Celecoxib

Product NDC
71610-283
Requested package NDC
71610-283-53
11-digit product format
716100283
Labeler code
71610
Product ID
71610-283_008fb44d-7296-4e3c-a9ad-a6e55b2033a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA020998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-12-10
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
2020-12-31
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 packagepackage71610-28371610-283-53DDiscontinued by firm2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-3184e616aacf4f…
2026-09-14 22:38:342026-08N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-3184e616aacf4f…
2026-09-14 22:38:342026-08N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-2984e616aacf4f…
2026-09-14 22:38:342026-08N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-1584e616aacf4f…
2026-08-18 06:07:402026-07N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31caaa826d4ba7…
2026-08-18 06:07:402026-07N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31caaa826d4ba7…
2026-08-18 06:07:402026-07N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020998-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020998-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020998-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N020998-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N020998-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020998-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020998-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020998-004AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-283-30EA - Each71610-28340c8c0eb-fc20-4dd6-81bc-41190578643b12019-07-02
71610-283-53EA - Each71610-2837edc62e7-25cd-4a96-a710-5a3a79e8530512019-07-02
71610-283-60EA - Each71610-2832de5e800-ae79-406d-8c25-80a91b33a56312019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-283CELECOXIB CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20190601_35550cbe-128b-4947-b5dd-a3166caa519e.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
71610-283-537161002835360 CAPSULE in 1 BOTTLE (71610-283-53) 60 capsule2019-05-240000-00-00NoNoCurrent