CELEBREX

Product NDC
63187-079
Requested package NDC
63187-079-15
11-digit product format
631870079
Labeler code
63187
Product ID
63187-079_df47793e-33f4-4823-b58f-ad991b48b22f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA020998
Marketing category
NDA
Marketing start
1998-10-02
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
200 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 packagepackage63187-07963187-079-15DDiscontinued by firm2026-08-07

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…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-079CELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]3Legacy NDC20210121_9f9dd7b9-a072-46d0-a8b5-b3e138c85f1c.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 · 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
63187-079-156318700791515 CAPSULE in 1 BOTTLE (63187-079-15) 15 capsule2019-01-010000-00-00NoNoCurrent