celecoxib

Product NDC
70518-2922
Requested package NDC
70518-2922-1
11-digit product format
705182922
Labeler code
70518
Product ID
70518-2922_caef5e61-0c35-187a-e053-2995a90acd5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204590
Marketing category
ANDA
Marketing start
2020-10-26
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
100 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-292270518-2922-1DDiscontinued by firm2026-08-17

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 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204590-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2016-03-16
A204590-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2016-03-16
A204590-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2016-03-16
A204590-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2016-03-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204590-001AB
A204590-002AB
A204590-003AB
A204590-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-16d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204590-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204590-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204590-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204590-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204590-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204590-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204590-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204590-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204590-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204590-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204590-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204590-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204590-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204590-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204590-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204590-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204590-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204590-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204590-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204590-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204590-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204590-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204590-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204590-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204590-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204590-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204590-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204590-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204590-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204590-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204590-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204590-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204590-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204590-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204590-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204590-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204590-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204590-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204590-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204590-004AB1d8e5a09893c0…

FDA-Initiated Inactive NDC Indexing#

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
celecoxibCELECOXIBHAWAII REPACK, INC.45816eae-ad83-4d2f-a035-c3f9f24708f92026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.78d59905-4a78-4d9f-ac29-58790a5b3a922026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBMacleods Pharmaceuticals Limitedd14aecf5-16e9-459a-bda4-4ca8f290796a2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBPreferred Pharmaceuticals Inc.a6000132-ac6c-4b61-a98a-8cc2dd84b3f02026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBPreferred Pharmaceuticals, Inc.2fc74af6-4573-411d-9082-f3edd44a52a42026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
CELECOXIBCELECOXIBDirect Rxac87b4f9-3f66-8cf7-e053-2995a90ade0f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBSportpharm LLC1ae11faa-5bbe-49b7-a4dd-b573c304cf662026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBNorthwind Health Company, LLCc213e224-c2fb-726e-e053-2a95a90a21c52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBBryant Ranch Prepack351f5f07-bdd4-9893-e063-6394a90a72812025-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBRedPharm Drug, Inc.50c29846-3426-0310-e054-00144ff8d46c2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBAsclemed USA, Inc.f6291230-7598-407a-aef0-ec1f09277d2a2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBBryant Ranch Prepackac5c0d72-1bb3-4065-b2f4-5516b08697752025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf73fea0-5cd1-0fa2-e053-2a95a90af8fc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCb3545cfb-97c3-b896-e053-2a95a90a15a02024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCc8ade384-2072-2cc2-e053-2a95a90ae7912024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf8fdd580-09da-9c1c-e053-6394a90a47062024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBQuality Care Products LLCf0df546e-17c9-4e85-839d-336612d7b9e52024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBNuCare Pharmaceuticals,Inc.69aebbab-9906-be86-e053-2991aa0aa8a52024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBAsclemed USA, Inc.2a926010-08e1-44dd-bc6d-ed15374bd0d32023-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590
celecoxibCELECOXIBProficient Rx LP0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d02022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204590
application number: ANDA204590

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2922-17051829220190 CAPSULE in 1 BOTTLE, PLASTIC (70518-2922-1) 90 capsule2021-08-310000-00-00NoNoCurrent