Celecoxib

Product NDC: 29300-374
11-digit product format: 293000374
Labeler code: 29300
Product ID: 29300-374_b8a15e41-8327-44ff-98c9-d7e7da8bb869
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA213301
Marketing category: ANDA
Marketing start: 2021-01-12
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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	Approval date
A213301-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12
A213301-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12
A213301-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12
A213301-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12

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.

Product history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A213301-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213301-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213301-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213301-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213301-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213301-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213301-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213301-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213301-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213301-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213301-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213301-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213301-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213301-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213301-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213301-004	AB	1	`5aa47cf7b7d7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Celecoxib
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CELECOXIB	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JCX84Q7J1L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205322	Internal RxNorm lookup
205323	Internal RxNorm lookup
349514	Internal RxNorm lookup
686379	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0e8484a8-04a6-4be3-8c5c-1883b0490d53	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9a	Product name	1	20200925
827beb42-45f2-95b8-6aa3-f35174375422	Product name	9	20160429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29300-374-16	Celecoxib	60 in 1 BOTTLE	CAPSULE	60		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-374	CELECOXIB CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	7	Current NDC, Legacy NDC, 1 package rows	20241222_0e8484a8-04a6-4be3-8c5c-1883b0490d53.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205322	celecoxib 100 MG Oral Capsule	PSN	0e8484a8-04a6-4be3-8c5c-1883b0490d53	7
205323	celecoxib 200 MG Oral Capsule	PSN	0e8484a8-04a6-4be3-8c5c-1883b0490d53	7
349514	celecoxib 400 MG Oral Capsule	PSN	0e8484a8-04a6-4be3-8c5c-1883b0490d53	7
686379	celecoxib 50 MG Oral Capsule	PSN	0e8484a8-04a6-4be3-8c5c-1883b0490d53	7
205322	celecoxib 100 MG Oral Capsule	SCD	0e8484a8-04a6-4be3-8c5c-1883b0490d53	7
205323	celecoxib 200 MG Oral Capsule	SCD	0e8484a8-04a6-4be3-8c5c-1883b0490d53	7
349514	celecoxib 400 MG Oral Capsule	SCD	0e8484a8-04a6-4be3-8c5c-1883b0490d53	7
686379	celecoxib 50 MG Oral Capsule	SCD	0e8484a8-04a6-4be3-8c5c-1883b0490d53	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-374-16	29300037416	60 CAPSULE in 1 BOTTLE (29300-374-16)	60 capsule	2021-08-01	0000-00-00	No	No	Current