Home NDC 0591-3982 Celecoxib
Product NDC 0591-3982
11-digit product format 005913982
Labeler code 0591
Product ID 0591-3982_42c5f4e4-5a65-4062-bf0a-b640659bc6f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA200562
Marketing category ANDA
Marketing start 2015-03-12
Marketing end 2027-03-31
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
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0591-3982 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0591-3982 0591-3982-00 UNFINISHED Active or certified unfinished drug listing 2026-08-17
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 0591-3982-00 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 0591-3982-00 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 0591-3982-00 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 0591-3982-00 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 0591-3982-00 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 0591-3982-00 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 0591-3982-00 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 0591-3982-00 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0591-3982-00 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0591-3982-00 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0591-3982-00 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0591-3982-00 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0591-3982-00 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 0591-3982-00 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 0591-3982-00 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 0591-3982-00 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 0591-3982-00 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 0591-3982-00 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 0591-3982-00 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 0591-3982-00 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 0591-3982-00 5b2001dcd8f5…54b53d4dc9e4…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 168 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 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200562-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200562-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200562-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200562-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-02-11 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Celecoxib 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 · 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-3982-60 Celecoxib 60 in 1 BOTTLE CAPSULE 60 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CELECOXIB ACTIVE INGREDIENT JCX84Q7J1L CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] 5 CELECOXIB ACTIVE MOIETY JCX84Q7J1L CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] 5 GELATIN INACTIVE INGREDIENT 2G86QN327L CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] 5 POVIDONES INACTIVE INGREDIENT FZ989GH94E CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3982 CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] 20 Current NDC, Legacy NDC, 1 package rows 20250411_05224473-27dc-4f6d-a52a-c40a7af2f2f4.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 ndc (product): 0591-3982 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 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 Marketing end Sample Exclude flag Status 0591-3982-00 00591398200 28735 CAPSULE in 1 CONTAINER (0591-3982-00) 28735 capsule 12-MAR-15 Current 0591-3982-60 00591398260 60 CAPSULE in 1 BOTTLE (0591-3982-60) 60 capsule 2015-03-12 2027-03-31 No No Current