Home NDC 76420-728-07 Celecoxib
Product NDC 76420-728
Requested package NDC 76420-728-07
11-digit product format 764200728
Labeler code 76420
Product ID 76420-728_1814718c-03dc-471b-e063-6394a90a880e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA200562
Marketing category ANDA
Marketing start 2015-03-12
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 43 .
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 A200562-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 A200562-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 A200562-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 A200562-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11
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 5 · 172 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 2026-09-14 22:38:34 2026-08 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-728 CELECOXIB CAPSULE [ASCLEMED USA, INC.] 1 Current NDC, 7 package rows 20240512_265b50cc-6d99-4ef8-8439-6792e1f21c68.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Celecoxib CELECOXIB Actavis Pharma, Inc. 05224473-27dc-4f6d-a52a-c40a7af2f2f4 2025-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200562 application number: ANDA200562 Celecoxib CELECOXIB Asclemed USA, Inc. 265b50cc-6d99-4ef8-8439-6792e1f21c68 2024-05-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200562 application number: ANDA200562 ndc (package): 76420-728-07 ndc (product): 76420-728 ndc11 (package): 76420072807 Celecoxib CELECOXIB Proficient Rx LP c529b321-38ed-434f-b76e-06902cdd40dc 2023-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200562 application number: ANDA200562
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76420-728-07 76420072807 7 CAPSULE in 1 BOTTLE (76420-728-07) 7 capsule 2024-05-10 No No Current