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NCE Grid Presents FDA Filing Intelligence
Search any molecule. See every FDA filer.
Look up every FDA drug application — NDAs (originators), ANDAs (generics), and BLAs (biologics) — by active ingredient, with the NDC codes and Orange Book therapeutic-equivalence ratings listed against each one.
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What app-level means
Drugs@FDA and the NDC Directory are two separate FDA datasets. This tool joins them on the application number, then narrows to the exact strength and dosage form. When that last step can't be resolved, the row is flagged.
- No flag
- The NDC codes shown are the ones listed for this exact strength and dosage form. Safe to quote against this line.
- app-level
- The NDC codes belong to this application, but not necessarily this strength. It usually happens when the labeler wrote the strength differently than Drugs@FDA did, or when the application covers a kit or a multi-strength pack. Treat the codes as a shortlist for the application and confirm the strength before quoting.
Also worth checking: a solid-outline NDC is the original packager's own listing. A dashed outline is a repackager or relabeler operating under the same application number — a different physical source. Hover any code to see its labeler.
The CSV export carries an NDC Match Quality column so you can filter these rows in Excel.
The CSV export carries an NDC Match Quality column so you can filter these rows in Excel.
Reading the TE code
The Therapeutic Equivalence code is FDA's Orange Book rating for whether a product can be substituted for the reference listed drug. The first letter is the whole story.
- A — therapeutically equivalent
- FDA considers the product substitutable for the reference drug. AB is the common case (bioequivalence demonstrated). AA means no bioequivalence issues exist in the first place; AP covers injectable solutions, AT topicals, AN inhalation solutions, AO injectable oils.
- B — not therapeutically equivalent
- FDA has not found the product substitutable — typically an unresolved bioequivalence question or a documented formulation issue. BX means the data are insufficient to determine equivalence. Do not treat a B-rated product as interchangeable.
The digit matters more than people expect. When a code carries a number — AB1, AB2, AB3 — the number identifies a distinct bioequivalence group. Products are substitutable only within the same number. An AB1 product is not interchangeable with an AB2 product, even though both are "AB". This happens when a molecule has several delivery designs that are each equivalent internally but not to each other, as with diltiazem's extended-release forms.
A blank TE code is normal for an originator NDA with no approved generic, for single-source products, and for discontinued listings — it does not imply a problem.
RLD marks the Reference Listed Drug, the product generics are filed against. RS marks the Reference Standard, the product used for bioequivalence testing.
Ratings shown here come from Drugs@FDA. For a filing decision, confirm against the current Orange Book.
A blank TE code is normal for an originator NDA with no approved generic, for single-source products, and for discontinued listings — it does not imply a problem.
RLD marks the Reference Listed Drug, the product generics are filed against. RS marks the Reference Standard, the product used for bioequivalence testing.
Ratings shown here come from Drugs@FDA. For a filing decision, confirm against the current Orange Book.
