Home NDC 63187-562 Celecoxib
Product NDC 63187-562
11-digit product format 631870562
Labeler code 63187
Product ID 63187-562_94327867-b615-4077-85a8-b7647355169b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
Application ANDA204197
Marketing category ANDA
Marketing start 2015-06-03
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 42 .
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 A204197-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 A204197-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 A204197-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02
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 · 126 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 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204197-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204197-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204197-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-06-02 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 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 63187-562-15 Celecoxib 15 in 1 BOTTLE CAPSULE 15 3 63187-562-30 Celecoxib 30 in 1 BOTTLE CAPSULE 30 3 63187-562-60 Celecoxib 60 in 1 BOTTLE CAPSULE 60 3 63187-562-90 Celecoxib 90 in 1 BOTTLE CAPSULE 90 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-562 CELECOXIB CAPSULE [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 4 package rows 20210113_6dd743d3-4821-4919-90eb-6d306ca7999f.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 d94849a7-1831-4319-982c-c6b20dc42038 2026-06-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204197 application number: ANDA204197 Celecoxib CELECOXIB PD-Rx Pharmaceuticals, Inc. 52572bfb-43f0-4b55-b1fd-231a05c8b83e 2026-05-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204197 application number: ANDA204197 Celecoxib CELECOXIB Apotex Corp. a62612b3-9564-2b34-be59-6aa5ac53679c 2026-04-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204197 application number: ANDA204197 Celecoxib CELECOXIB A-S Medication Solutions 217265c0-e98e-482c-8af2-f8ac0ab7a0a1 2024-09-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204197 application number: ANDA204197 Celecoxib CELECOXIB Proficient Rx LP 6dd743d3-4821-4919-90eb-6d306ca7999f 2021-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204197 application number: ANDA204197 ndc (product): 63187-562
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 63187-562-15 63187056215 15 CAPSULE in 1 BOTTLE (63187-562-15) 15 capsule 2018-12-01 0000-00-00 No No Current 63187-562-30 63187056230 30 CAPSULE in 1 BOTTLE (63187-562-30) 30 capsule 2018-12-01 0000-00-00 No No Current 63187-562-60 63187056260 60 CAPSULE in 1 BOTTLE (63187-562-60) 60 capsule 2018-12-01 0000-00-00 No No Current 63187-562-90 63187056290 90 CAPSULE in 1 BOTTLE (63187-562-90) 90 capsule 2018-12-01 0000-00-00 No No Current