FDA.reportPublic FDA data

Celecoxib

Product NDC
81288-023
11-digit product format
812880023
Labeler code
81288
Product ID
81288-023_9dca0e35-a3f7-499a-a256-ad4de9a78812
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
EMC PHARMA, LLC
Application
ANDA211412
Marketing category
ANDA
Marketing start
2022-07-18
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
400 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct81288-023DDiscontinued by firm2026-08-03
excluded packagepackage81288-02381288-023-10DDiscontinued by firm2026-08-03
excluded packagepackage81288-02381288-023-20DDiscontinued by firm2026-08-03
excluded packagepackage81288-02381288-023-30DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211412-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2020-03-06
A211412-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2020-03-06
A211412-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2020-03-06
A211412-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2020-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A211412-001AB
A211412-002AB
A211412-003AB
A211412-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211412-001CELECOXIB50MGCAPSULE / ORALAB2020-03-06a50c72e98297…
2026-08-01 22:54:322026-06A211412-002CELECOXIB100MGCAPSULE / ORALAB2020-03-06a50c72e98297…
2026-08-01 22:54:322026-06A211412-003CELECOXIB200MGCAPSULE / ORALAB2020-03-06a50c72e98297…
2026-08-01 22:54:322026-06A211412-004CELECOXIB400MGCAPSULE / ORALAB2020-03-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211412-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211412-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A211412-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A211412-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBAvet Pharmaceuticals Inc.4bc96d0c-b484-3cee-e063-6294a90a91932026-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211412
application number: ANDA211412
CelecoxibCELECOXIBYiling Pharmaceutical, Inc.43979279-867b-4303-8f30-fc58ae75a0692025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211412
application number: ANDA211412
CelecoxibCELECOXIBChartwell RX, LLCa99a67f3-ccaa-4d54-8922-d6dd30fba2742025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211412
application number: ANDA211412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81288-023-108128800231060 CAPSULE in 1 BOTTLE (81288-023-10) 60 capsule2022-07-180000-00-00NoNoCurrent
81288-023-2081288002320100 CAPSULE in 1 BOTTLE (81288-023-20) 100 capsule2022-07-180000-00-00NoNoCurrent
81288-023-3081288002330500 CAPSULE in 1 BOTTLE (81288-023-30) 500 capsule2022-07-180000-00-00NoNoCurrent