ASassyro
FDA Orange Book

Search FDA Orange Book

Search the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations): every NDA and ANDA drug product with its therapeutic equivalence (TE) code, Reference Listed Drug (RLD) and Reference Standard (RS) status, marketing status, listed patents and exclusivities. Use it for generic entry questions (which ANDAs reference an RLD, which are AB-rated), the patent and exclusivity landscape of a drug (patents expiring in a window, NCE/ODE/PED exclusivity end dates), and therapeutic equivalence. A TE code starting with A means FDA rates the product therapeutically equivalent; B means it does not. Data comes from FDA's monthly Orange Book data files, not the daily web site: each record's version is the edition (YYYY-MM). State that edition, and send the user to the record url for anything time-critical. Cite each product by its application and product number (for example NDA 215866 product 001, id N215866-001). Read the product before relying on patent use codes or exclusivity details. Give at least one filter; a search with sort newest and no filter lists the latest approvals.

get/v1/sources/orange-book/search

Request

  • Base URL
    https://api.assyro.com
  • Auth
    none declared

Query parameters

querystring

Words that must all appear in the ingredient, trade name or applicant, e.g. "budesonide foam".

ingredientstring

Active ingredient, substring match, e.g. "tirzepatide".

tradeNamestring

Trade (brand) name, substring match, e.g. "Mounjaro".

applicantstring

Applicant (holder) name, substring match.

applicationNumberstring

NDA or ANDA number, e.g. N215866, NDA 215866, A215328, or N215866-001 for one product.

applicationType'NDA' | 'ANDA'

NDA (brand, 505(b)) or ANDA (generic).

teCodesstring[]

TE codes. A two-letter code matches its numbered variants (AB matches AB1, AB2).

rldboolean

true for Reference Listed Drugs only.

rsboolean

true for Reference Standards only.

dosageFormstring

Dosage form, substring match, e.g. "TABLET, EXTENDED RELEASE".

routestring

Route, substring match, e.g. "ORAL", "SUBCUTANEOUS".

marketingStatusesstring[]

RX (prescription), OTC, DISCN (discontinued). Omit for all.

hasPatentsboolean

true: only products with listed patents; false: only products without.

patentExpiryFromstring

Products with a listed patent expiring on or after this date, YYYY-MM-DD.

patentExpiryTostring

Products with a listed patent expiring on or before this date, YYYY-MM-DD.

hasExclusivityboolean

true: only products with listed exclusivities; false: only products without.

exclusivityCodesstring[]

Exclusivity codes: NCE, ODE, PED, NP, NPP, NS, I, D, M, GAIN, CGT, PC. A base code matches its numbered forms (ODE matches ODE-123).

exclusivityExpiryFromstring

Exclusivity expiring on or after this date, YYYY-MM-DD.

exclusivityExpiryTostring

Exclusivity expiring on or before this date, YYYY-MM-DD.

approvedFromstring

Earliest approval date, YYYY-MM-DD.

approvedTostring

Latest approval date, YYYY-MM-DD.

sort'relevance' | 'newest' | 'patentExpiry'

relevance (default: RLDs and reference standards first, marketed before discontinued), newest approval first, or patentExpiry (earliest patent expiry in the window first).

limitinteger

How many products to return (default 8). total reports every match.

offsetinteger

Skip this many results (for paging), default 0.

Response

Matching records.

versionunknown required
totalinteger nullable required

Total matches the source reports, when it says.

notestring
summarystring[]

Changes

No recorded changes to this operation across all 1 revision of this API.