Home NDC 72241-023 Celecoxib
Product NDC 72241-023
11-digit product format 722410023
Labeler code 72241
Product ID 72241-023_75f7a2cd-9aa3-4f66-a708-f3f6a8a571da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Modavar Pharmaceuticals LLC
Application ANDA208701
Marketing category ANDA
Marketing start 2021-08-23
Substance CELECOXIB
Active strength 100 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 100 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 72241-023-03 Celecoxib 60 in 1 BOTTLE CAPSULE 60 4 72241-023-05 Celecoxib 100 in 1 BOTTLE CAPSULE 100 4 72241-023-10 Celecoxib 500 in 1 BOTTLE CAPSULE 500 4 72241-023-11 Celecoxib 1000 in 1 BOTTLE CAPSULE 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72241-023 CELECOXIB CAPSULE [MODAVAR PHARMACEUTICALS LLC] 4 Current NDC, Legacy NDC, 4 package rows 20250108_b0f73074-f3d8-4812-8e64-f88a02869ed3.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 ndc (product): 72241-023 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 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 72241-023-03 72241002303 60 CAPSULE in 1 BOTTLE (72241-023-03) 60 capsule 2021-08-23 0000-00-00 No No Current 72241-023-05 72241002305 100 CAPSULE in 1 BOTTLE (72241-023-05) 100 capsule 2021-08-23 0000-00-00 No No Current 72241-023-10 72241002310 500 CAPSULE in 1 BOTTLE (72241-023-10) 500 capsule 2021-08-23 0000-00-00 No No Current 72241-023-11 72241002311 1000 CAPSULE in 1 BOTTLE (72241-023-11) 1000 capsule 2021-08-23 0000-00-00 No No Current