Home NDC 69367-302 Celecoxib
Product NDC 69367-302
11-digit product format 693670302
Labeler code 69367
Product ID 69367-302_98458883-6f96-4aa8-8feb-4d940b51c88d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Application ANDA210071
Marketing category ANDA
Marketing start 2020-12-21
Substance CELECOXIB
Active strength 200 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 · 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CELECOXIB 200 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205322 Internal RxNorm lookup 205323 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 69367-302-01 Celecoxib 100 in 1 BOTTLE CAPSULE 100 6 69367-302-05 Celecoxib 500 in 1 BOTTLE CAPSULE 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-302 CELECOXIB CAPSULE [WESTMINSTER PHARMACEUTICALS, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241206_cb0be640-067e-4422-9bec-d5fa07175bd0.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 Marketing end Sample Exclude flag Status 69367-302-01 69367030201 100 CAPSULE in 1 BOTTLE (69367-302-01) 100 capsule 2020-12-21 0000-00-00 No No Current 69367-302-05 69367030205 500 CAPSULE in 1 BOTTLE (69367-302-05) 500 capsule 2020-12-21 0000-00-00 No No Current