/openfda/drug/orangebook

POST /api/openfda/drug/orangebook

Price: 1 credit

Get an FDA Orange Book product by its application and product number

How to use it

One Orange Book product — the approved-drug list that carries the patent and exclusivity terms no other endpoint here has. The id is the application number plus the product number ('NDA020702-001'); the same application usually has several products, one per strength. `patents` sit on brand (NDA) products only. Generics do hold exclusivity: an ANDA can carry a competitive-generic (CGT) or patent-challenge (PC) term, which the search endpoint isolates with has_exclusivity plus application_type=ANDA. `therapeutic_equivalence_codes` say which products substitute for each other (AB codes) and are absent on discontinued and OTC products. Drop the '-001' and prefix the number to call openfda/drug/approvals for the same application's submission history.

Parameters

• access-token string required

Request body

• timeout integer — Max scrapping execution timeout (in seconds) (default: 300; min: 20; max: 1500)
• id string required — Orange Book product id: FDA application number and product number, for example 'NDA020702-001' (examples: "NDA020702-001", "ANDA076708-001"; minLength: 1)

Response

• @type string (default: "OpenfdaDrugOrangebook")
• id string required
• application_number string required
• application_type string nullable
• product_number string nullable
• brand_name string nullable
• applicant string nullable
• applicant_full_name string nullable
• dosage_form string nullable
• route string nullable
• marketing_status string nullable
• therapeutic_equivalence_codes array (default: [])
• is_reference_listed_drug boolean nullable
• is_reference_standard boolean nullable
• approval_at integer nullable
• is_approved_prior_to_1982 boolean nullable
• active_ingredients array (default: [])
  • @type string (default: "OpenfdaNdcActiveIngredient")
  • name string required
  • strength string nullable
• patents array (default: [])
  • @type string (default: "OpenfdaOrangebookPatent")
  • patent_number string required
  • expiration_at integer nullable
  • submission_at integer nullable
  • use_code string nullable
  • is_drug_product boolean nullable
  • is_drug_substance boolean nullable
  • is_delisted boolean nullable
• exclusivity array (default: [])
  • @type string (default: "OpenfdaOrangebookExclusivity")
  • exclusivity_code string required
  • expiration_at integer nullable
• web_url string (default: "")

Errors

• 422 — The request body did not validate Check the fields against this schema. A URN with the wrong prefix is the most common cause.
• 408 — The request ran past its time limit Raise `timeout` in the request body, up to the maximum this endpoint documents. Lowering `count` or turning off the `with_*` flags also helps, because less work finishes sooner.
• 412 — Orange Book product not found Retrying will not help: either the entity does not exist, or the input points at a different one.
• 429 — Too many requests: a rate limit or a usage window is exhausted When the response carries an X-Retry-After header, wait that many seconds and retry: the same number is in the body as `detail.retry_after`, and the limit clears once that window passes. The message in the body names the limit that was hit.
• 500 — Something broke on our side Retrying will not help. If it keeps happening, send us the X-Request-ID from the response headers.
• 529 — Rate limit reached, or the endpoint is overloaded Wait at least 30 seconds, then retry.

Response headers

• X-Error — Error message text (present only on error)
• X-Request-ID — Unique request identifier
• X-Execution-Time — Execution time in seconds
• X-Result-Count — How many records the body carries. 0 means an empty result, which is a normal answer and not by itself an error. A non-zero count can come back together with X-Error when the failure happened partway through — read this header and X-Error independently.
• X-Total-Available-Results — How many records exist for this query, when the endpoint can say. On a `dry_run` request this is the answer and the body is empty. It saturates: the endpoint's documented maximum means 'at least that many', any smaller number is exact.
• X-Warning — Present when the request body carried keys this endpoint does not document. They were ignored, so any filter you meant to apply through them did not apply. Check the spelling against this schema and retry.
• X-Retry-After — Seconds to wait before retrying. Present only on 429.