Home NDC 71209-054 Celecoxib
Product NDC 71209-054
11-digit product format 712090054
Labeler code 71209
Product ID 71209-054_491c8284-c565-4c6b-8d88-4373b179be4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Cadila Pharmaceuticals Limited
Application ANDA208701
Marketing category ANDA
Marketing start 2015-12-09
Substance CELECOXIB
Active strength 50 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 42 .
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 A208701-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 A208701-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 A208701-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 A208701-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208701-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208701-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208701-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208701-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-14 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 156 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Celecoxib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CELECOXIB 50 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 71209-054-03 Celecoxib 60 in 1 BOTTLE CAPSULE 60 14 71209-054-11 Celecoxib 1000 in 1 BOTTLE CAPSULE 1000 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71209-054 CELECOXIB CAPSULE [CADILA PHARMACEUTICALS LIMITED] 14 Current NDC, Legacy NDC, 2 package rows 20241212_78ce3df5-07ee-43bb-9348-104a9524a032.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Celecoxib CELECOXIB REMEDYREPACK INC. 56d64558-1fad-420e-8fcd-7103cd073127 2026-05-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208701 application number: ANDA208701 Celecoxib CELECOXIB Modavar Pharmaceuticals LLC b0f73074-f3d8-4812-8e64-f88a02869ed3 2024-12-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208701 application number: ANDA208701 Celecoxib CELECOXIB Cadila Pharmaceuticals Limited 78ce3df5-07ee-43bb-9348-104a9524a032 2024-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208701 application number: ANDA208701 ndc (product): 71209-054 Celecoxib CELECOXIB Bryant Ranch Prepack 1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a6 2024-11-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208701 application number: ANDA208701
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 71209-054-03 71209005403 60 CAPSULE in 1 BOTTLE (71209-054-03) 60 capsule 2018-08-23 0000-00-00 No No Current 71209-054-11 71209005411 1000 CAPSULE in 1 BOTTLE (71209-054-11) 1000 capsule 2018-08-23 0000-00-00 No No Current