Home NDC 29300-374 Celecoxib
Product NDC 29300-374
11-digit product format 293000374
Labeler code 29300
Product ID 29300-374_fbb9cff1-8a87-4280-a3f1-4d0560d65b0d
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 2026-12-31
Current FDA listing Yes 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 RLD / RS 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 · 140 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213301-001 CELECOXIB 50MG CAPSULE / ORAL 2021-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213301-002 CELECOXIB 100MG CAPSULE / ORAL 2021-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213301-003 CELECOXIB 200MG CAPSULE / ORAL 2021-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213301-004 CELECOXIB 400MG CAPSULE / ORAL 2021-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213301-001 CELECOXIB 50MG CAPSULE / ORAL 2021-01-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213301-002 CELECOXIB 100MG CAPSULE / ORAL 2021-01-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213301-003 CELECOXIB 200MG CAPSULE / ORAL 2021-01-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213301-004 CELECOXIB 400MG CAPSULE / ORAL 2021-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213301-001 CELECOXIB 50MG CAPSULE / ORAL 2021-01-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213301-002 CELECOXIB 100MG CAPSULE / ORAL 2021-01-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213301-003 CELECOXIB 200MG CAPSULE / ORAL 2021-01-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213301-004 CELECOXIB 400MG CAPSULE / ORAL 2021-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213301-001 CELECOXIB 50MG CAPSULE / ORAL 2021-01-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213301-002 CELECOXIB 100MG CAPSULE / ORAL 2021-01-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213301-003 CELECOXIB 200MG CAPSULE / ORAL 2021-01-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213301-004 CELECOXIB 400MG CAPSULE / ORAL 2021-01-12 d06236e962d9…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Celecoxib
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Celecoxib CELECOXIB Unichem Pharmaceuticals (USA), Inc. 0e8484a8-04a6-4be3-8c5c-1883b0490d53 2024-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213301 application number: ANDA213301 ndc (product): 29300-374
DailyMed RxNorm Mappings# 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