Celecoxib

Product NDC: 81288-023
Requested package NDC: 81288-023-10
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	81288-023	81288-023-10	D	Discontinued by firm		2026-08-03

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211412-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-03-06
A211412-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-03-06
A211412-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-03-06
A211412-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-03-06

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A211412-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211412-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211412-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211412-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-03-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A211412-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211412-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211412-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211412-004	AB	1	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Avet Pharmaceuticals Inc.	4bc96d0c-b484-3cee-e063-6294a90a9193	2026-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211412 application number: ANDA211412
Celecoxib	CELECOXIB	Yiling Pharmaceutical, Inc.	43979279-867b-4303-8f30-fc58ae75a069	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211412 application number: ANDA211412
Celecoxib	CELECOXIB	Chartwell RX, LLC	a99a67f3-ccaa-4d54-8922-d6dd30fba274	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211412 application number: ANDA211412

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JCX84Q7J1L	CELECOXIB	169590-42-5	CELECOXIB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81288-023-10	81288002310	60 CAPSULE in 1 BOTTLE (81288-023-10)	60 capsule	2022-07-18	0000-00-00	No	No	Current