Home NDC 83301-0028 Celecoxib
Product NDC 83301-0028
11-digit product format 833010028
Labeler code 83301
Product ID 83301-0028_596c7695-b38d-0d40-e063-6394a90ac40f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Mullan Pharmaceutical Inc.
Application ANDA210071
Marketing category ANDA
Marketing start 2024-01-01
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 2027-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210071-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 A210071-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 A210071-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 129 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 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210071-002 CELECOXIB 100MG CAPSULE / ORAL AB 2018-01-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210071-003 CELECOXIB 200MG CAPSULE / ORAL AB 2018-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210071-001 CELECOXIB 50MG CAPSULE / ORAL AB 2018-01-23 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205322 Internal RxNorm lookup 205323 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 83301-0028-1 Celecoxib 60 in 1 BOTTLE CAPSULE 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83301-0028 CELECOXIB CAPSULE [MULLAN PHARMACEUTICAL INC.] 2 Current NDC, 1 package rows 20250425_643e177f-216d-4dfa-824a-7516a488304e.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 2 of 2 · 22 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83301-0028-1 83301002801 60 CAPSULE in 1 BOTTLE (83301-0028-1) 60 capsule 2024-01-01 No No Current