Home NDC 80425-0281 Celecoxib
Product NDC 80425-0281
11-digit product format 804250281
Labeler code 80425
Product ID 80425-0281_2a9ba8f4-6cea-e827-e063-6394a90a0300
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA210628
Marketing category ANDA
Marketing start 2023-03-03
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 44 .
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 A210628-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 A210628-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 A210628-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 A210628-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27
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 · 164 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 2026-10-15 13:18:30 2026-09 A210628-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A210628-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A210628-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A210628-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A210628-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210628-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210628-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210628-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210628-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210628-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210628-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210628-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210628-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210628-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210628-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210628-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210628-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210628-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210628-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210628-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210628-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210628-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210628-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210628-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210628-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210628-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210628-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210628-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210628-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210628-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210628-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210628-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210628-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210628-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210628-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210628-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210628-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210628-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210628-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210628-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-11-27 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 80425-0281-1 Celecoxib 30 in 1 BOTTLE CAPSULE 30 2 80425-0281-2 Celecoxib 60 in 1 BOTTLE CAPSULE 60 2 80425-0281-3 Celecoxib 90 in 1 BOTTLE CAPSULE 90 2 80425-0281-4 Celecoxib 180 in 1 BOTTLE CAPSULE 180 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0281 CELECOXIB CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 4 package rows 20250102_f60394f5-fd69-929b-e053-2995a90a5793.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CELECOXIB CELECOXIB Bryant Ranch Prepack fd569104-8243-48fa-8e93-5a08654ad6dd 2026-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210628 application number: ANDA210628 CELECOXIB CELECOXIB Bryant Ranch Prepack 47be1d99-eebb-42f9-80d9-291a024b1364 2026-03-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210628 application number: ANDA210628 CELECOXIB CELECOXIB NIVAGEN PHARMACEUTICALS, INC. ae7943ab-b1fc-f08f-e053-2995a90a051e 2026-01-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210628 application number: ANDA210628 CELECOXIB CELECOXIB PHOENIX RX LLC 3a669c28-fbc7-827c-e063-6394a90a0829 2025-08-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210628 application number: ANDA210628 Celecoxib CELECOXIB Advanced Rx Pharmacy of Tennessee, LLC f60394f5-fd69-929b-e053-2995a90a5793 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210628 application number: ANDA210628 ndc (product): 80425-0281
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0281-1 80425028101 30 CAPSULE in 1 BOTTLE (80425-0281-1) 30 capsule 2023-03-03 No No Current 80425-0281-2 80425028102 60 CAPSULE in 1 BOTTLE (80425-0281-2) 60 capsule 2023-03-03 No No Current 80425-0281-3 80425028103 90 CAPSULE in 1 BOTTLE (80425-0281-3) 90 capsule 2023-03-03 No No Current 80425-0281-4 80425028104 180 CAPSULE in 1 BOTTLE (80425-0281-4) 180 capsule 2023-03-03 No No Current