Reference

Glossary of Terms

Key terminology used throughout this site, the database, and the pharmaceutical industry. Understanding these terms will help you interpret the data and make more informed comparisons.

FDA & Regulatory

FDA: Food and Drug Administration. The US federal agency responsible for regulating drugs, including approving new medications, inspecting manufacturing facilities, and enforcing safety standards.
NDA (New Drug Application): The application a drug manufacturer submits to the FDA to request approval to market a new brand-name drug. Contains full clinical trial data, manufacturing details, and proposed labeling.
ANDA (Abbreviated New Drug Application): The application for generic drug approval. "Abbreviated" because the generic manufacturer can reference the brand-name drug's clinical data instead of conducting their own full trials. Must demonstrate bioequivalence.
CGMP (Current Good Manufacturing Practice): FDA regulations that establish the minimum requirements for the methods, facilities, and controls used in manufacturing pharmaceuticals. Violations can result in warning letters, import alerts, or facility shutdowns.
Warning Letter: An official FDA communication to a manufacturer notifying them of significant regulatory violations found during an inspection. Requires a corrective action response. Public record.
Class I Recall: The most serious type of FDA recall. There is a reasonable probability that the product will cause serious adverse health consequences or death. Rare for ADHD medications.
Class II Recall: A situation where the product may cause temporary or medically reversible adverse health consequences. The most common recall classification for ADHD drugs — includes dissolution failures, impurity issues, and labeling errors.
Class III Recall: A situation where the product is not likely to cause adverse health consequences. Typically involves minor labeling issues or packaging defects.
DEA Schedule / CII: The Drug Enforcement Administration classifies controlled substances into schedules I-V. Most ADHD stimulants (amphetamine, methylphenidate) are Schedule II (CII) — high potential for abuse, currently accepted medical use, severe psychological or physical dependence potential.
DMF (Drug Master File): A confidential submission to the FDA containing detailed information about facilities, processes, or articles used in drug manufacturing. API suppliers file DMFs so that drug manufacturers can reference them without disclosing proprietary manufacturing details.

Drug Product Identifiers

NDC (National Drug Code): A unique 10-digit, 3-segment number identifying a specific drug product. The three segments identify the labeler (manufacturer/distributor), the product (drug, strength, dosage form), and the package size. Every marketed drug in the US has an NDC.
SPL (Structured Product Labeling): The standardized XML format used to submit drug labeling information to the FDA via DailyMed. Contains the full drug label including ingredients (active and inactive), manufacturer information, establishment data, warnings, and dosing. This is our primary data source for inactive ingredients.
FEI Number (FDA Establishment Identifier): A unique number assigned by the FDA to each registered drug manufacturing facility. Used to track inspections, compliance history, and facility registrations. Each physical manufacturing location has its own FEI, even if owned by the same company.
DUNS Number: A 9-digit identifier assigned by Dun & Bradstreet to business entities. Used in SPL filings to identify establishments. Not the same as FEI — a facility has both a DUNS number (business identity) and an FEI number (FDA regulatory identity).
UNII Code: Unique Ingredient Identifier. An alphanumeric code assigned by the FDA to each substance (active and inactive) used in drugs. Enables precise identification regardless of naming variations — "magnesium stearate NF" and "MAGNESIUM STEARATE" both map to the same UNII.
Set ID: A unique identifier for an SPL document that persists across all versions of a drug label. When a manufacturer updates their label (new warnings, reformulation), the set ID stays the same but the version number increments. We use set IDs to track formulation history over time.

Drug Formulation

Active Ingredient: The substance in a medication that produces the therapeutic effect. For example, methylphenidate hydrochloride is the active ingredient in Concerta. Generic drugs must contain the same active ingredient at the same strength as the brand-name version.
Inactive Ingredient (Excipient): Any substance in a drug product other than the active ingredient. Includes binders, fillers, coatings, colorants, preservatives, and flavoring agents. Generics can use completely different inactive ingredients from the brand-name drug — this is the core focus of our database.
Excipient: Another term for inactive ingredient. Pharmaceutical excipients serve specific functions: binders hold tablets together, disintegrants help them break apart, lubricants prevent sticking during manufacturing, coatings protect or control release, and colorants aid identification.
Formulation: The specific combination of active and inactive ingredients, along with their proportions and manufacturing process, that make up a drug product. Two generics of the same drug may have very different formulations despite having the same active ingredient.
Bioequivalence: The FDA standard for generic drug approval. A generic is bioequivalent if it delivers the same amount of active ingredient to the bloodstream at the same rate as the brand-name drug. Bioequivalence testing does not evaluate differences in inactive ingredients.
Dissolution: The process by which a solid drug dissolves in fluid. Dissolution testing measures how quickly a tablet or capsule releases its active ingredient. Failed dissolution specifications are a common reason for ADHD medication recalls — the drug doesn't dissolve as expected, potentially reducing effectiveness.
Dosage Form: The physical form of a drug product: tablet, capsule, solution, patch, etc. "TABLET" is immediate-release; "CAPSULE, EXTENDED RELEASE" delivers the drug gradually over hours. Different dosage forms of the same drug (e.g., Adderall IR tablets vs. Adderall XR capsules) use fundamentally different inactive ingredients.
Immediate Release (IR): A dosage form that releases the active ingredient immediately after ingestion. The drug enters the bloodstream quickly, producing a faster onset but shorter duration of effect. Adderall IR tablets typically last 4-6 hours.
Extended Release (ER/XR): A dosage form engineered to release the active ingredient gradually over an extended period. Uses specialized coatings, beads, or matrix systems that require additional inactive ingredients. Adderall XR capsules contain coated beads that release in two phases, lasting 10-12 hours.

Supply Chain

Labeler: The company whose name appears on the drug label — usually the manufacturer or distributor. The first segment of the NDC code identifies the labeler. A labeler may or may not be the actual manufacturer; some labelers contract manufacturing to other companies.
Manufacturer: A company that actually produces the drug product — synthesizing the API, formulating the final dosage form, or both. In our database, we distinguish actual manufacturers from repackagers and distributors.
Repackager: A company that purchases finished medications from the original manufacturer and repackages them into different container sizes (e.g., splitting a 1,000-count bottle into 30-count bottles). They never alter the drug itself — same pills, different packaging. They file their own SPLs and get their own NDC codes, which is why they appear in our database. We tag them as repackagers and hide them from rankings by default.
CMO (Contract Manufacturing Organization): A company that manufactures drugs on behalf of another company. Many brand-name pharmaceutical companies (including Takeda for Vyvanse) don't own manufacturing facilities — they contract with CMOs like Patheon (Thermo Fisher) or Cambrex. CMO relationships are sometimes disclosed in SPL filings.
API (Active Pharmaceutical Ingredient): The raw active substance before it's formulated into a finished drug product. API manufacturing is often done at specialized facilities, sometimes in different countries from where the final drug is made. "API MANUFACTURE" in our supply chain data indicates where the raw active ingredient is synthesized.
FDF (Finished Dosage Form): The final drug product ready for patient use — the actual tablet, capsule, or solution. "FDF MANUFACTURE" indicates where the final drug is produced from the API and excipients.
Supply Chain Roles: The specific functions a facility performs: API MANUFACTURE (synthesize active ingredient), MANUFACTURE (produce finished drug), ANALYSIS (quality testing), PACK (packaging), LABEL (labeling), REPACK (repackaging), RELABEL (relabeling). A single facility may perform multiple roles.

Ingredient Categories

Binder: Holds tablet ingredients together during compression. Common examples: microcrystalline cellulose, povidone, hydroxypropyl cellulose.
Filler / Diluent: Adds bulk to a tablet when the active ingredient dose is very small. Common examples: lactose monohydrate, mannitol, microcrystalline cellulose, starch.
Disintegrant: Helps a tablet break apart after swallowing so the drug can dissolve. Common examples: croscarmellose sodium, sodium starch glycolate, crospovidone.
Lubricant: Prevents the drug mixture from sticking to manufacturing equipment during tablet compression. Magnesium stearate is by far the most common pharmaceutical lubricant — present in virtually every compressed tablet.
Glidant: Improves powder flow during manufacturing by reducing friction between particles. Silicon dioxide (colloidal silicon dioxide) is the most common glidant.
Coating: A film or layer applied to the outside of a tablet or capsule. Protects the drug from moisture, masks taste, controls release, or aids identification. Coatings often include polymers (hypromellose), plasticizers (triethyl citrate), and opacifiers (titanium dioxide).
Colorant: Dyes or pigments added for product identification and visual differentiation between strengths. Includes synthetic dyes (FD&C Blue No. 1, FD&C Yellow No. 6) and iron oxide pigments. Some synthetic dyes are flagged as allergens in our database due to sensitivity risks.
Sustained-Release Agent: Polymers and materials that control how quickly the drug is released in the body. Essential for extended-release formulations. Examples: methacrylic acid copolymers, ethylcellulose, hypromellose. This is why XR products have more ingredients than IR versions.
Enteric Coating: A coating that resists stomach acid but dissolves in the intestine. Protects acid-sensitive drugs or prevents stomach irritation. Used in some methylphenidate extended-release products.
Allergen (in our database): An ingredient we've flagged as having known sensitivity or allergy potential. Includes: FD&C dyes (especially Yellow No. 5/tartrazine), lactose (lactose intolerance), gelatin (animal-derived), aspartame (contains phenylalanine — dangerous for PKU), and corn starch (rare corn allergy). 50 ingredients in our database carry allergen flags.

Our Database & Methodology

Formulation Change: A confirmed modification to a drug's inactive ingredient list between two consecutive SPL versions. We detect these by comparing SHA-256 hashes of sorted, normalized ingredient lists. Not all SPL version updates are formulation changes — most are labeling updates (new warnings, dosing changes). Some detected "changes" may be relabeling rather than real reformulation (e.g., "gelatin" → "gelatin, unspecified").
Manufacturer Ranking Score: Our composite 0-100 score for each manufacturer per drug. Weighted: supply chain transparency (35%), FDA recall history (40%), ingredient disclosure (15%), formulation stability (10%). Manufacturers declaring zero facilities receive a non-disclosure penalty. Rankings are calculated separately for Adderall IR and XR since they are different formulations.
Non-Disclosure Penalty: A deduction applied to a manufacturer's supply chain score when they declare zero facilities in their FDA drug label filing. Many manufacturers — including some of the largest generic companies — disclose minimal or no supply chain information in their SPLs, making it impossible to trace where their drugs are made from public data alone.
FEI Registry Match: A supply chain entry that was not declared in the drug's SPL filing but was matched by cross-referencing the manufacturer's name against the FDA's facility registration database. These entries show the broader manufacturing network a company has registered with the FDA, even if they don't disclose which specific facilities make which drugs.
Historical Facility: A facility that appeared in an SPL filing but whose FEI number is no longer present in the current year's FDA facility registration data. May indicate the facility was closed, sold, or its registration lapsed. Active facilities are confirmed in the most recent fiscal year's FEI data.

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