CELEBREX

Product NDC
63629-3021
Requested package NDC
63629-3021-2
11-digit product format
636293021
Labeler code
63629
Product ID
63629-3021_22d6020b-a76e-5068-e98c-299310df2898
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA020998
Marketing category
NDA
Marketing start
1998-10-02
Marketing end
0000-00-00
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
2023-12-31
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 packagepackage63629-302163629-3021-2DDiscontinued by firm2026-08-11

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020998-001CELEBREXCELECOXIB100MGCAPSULE / ORALABRLD1998-12-31
N020998-002CELEBREXCELECOXIB200MGCAPSULE / ORALABRLD1998-12-31
N020998-003CELEBREXCELECOXIB400MGCAPSULE / ORALABRLD, RS2002-08-29
N020998-004CELEBREXCELECOXIB50MGCAPSULE / ORALABRLD2006-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020998-001AB
N020998-002AB
N020998-003AB
N020998-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020998-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020998-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020998-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-004AB1d06236e962d9…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-3021-02020-10-16These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-12020-10-16These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-22020-10-16These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-32020-10-16These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-42020-10-16These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-52020-10-16These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-62020-10-16These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-72020-10-16These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-82020-10-16These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-92020-10-16These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-02020-01-31These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-12020-01-31These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-22020-01-31These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-32020-01-31These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-42020-01-31These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-52020-01-31These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-62020-01-31These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-72020-01-31These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-82020-01-31These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
63629-3021-92020-01-31These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3021-0EA - Each63629-3021669dbd19-17a2-4513-851e-b967bd84839412015-10-02
63629-3021-1EA - Each63629-30219a35d96a-5aa3-4efe-95f9-39bcb79a2cac12012-07-24
63629-3021-2EA - Each63629-3021a1df2611-e6a3-4770-8bd6-a853cb04ae4a12012-07-24
63629-3021-3EA - Each63629-3021ad6d289a-741e-406e-94bd-272a870363c512012-07-24
63629-3021-4EA - Each63629-3021099ce832-36e5-473a-867e-c7eb7d62570112012-07-24
63629-3021-5EA - Each63629-302170a8888e-dd1d-4f3d-bb2a-7bb29f9ecea512012-07-24
63629-3021-6EA - Each63629-30213ad5d2ba-f062-4e43-873b-3cd0765726fa12012-07-24
63629-3021-7EA - Each63629-3021901bdc30-b797-47c0-93d6-9bd65289a5a412012-07-24
63629-3021-8EA - Each63629-30216d5a23cc-4d58-4728-8e05-f57be06356b212012-07-24
63629-3021-9EA - Each63629-302170562e49-0ae0-470e-a89b-1986513e6d8612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CelecoxibACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]2
CelecoxibACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]2
gelatinINACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]2
povidoneINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCELEBREX (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]2

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELEBREXCELECOXIBViatris Specialty LLC2d6675e4-5859-4be2-8037-a20ce9f707aa2024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020998
application number: NDA020998

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3021-26362930210220 CAPSULE in 1 BOTTLE (63629-3021-2) 20 capsule2008-10-240000-00-00NoNoCurrent