Celecoxib

Product NDC
80425-0167
11-digit product format
804250167
Labeler code
80425
Product ID
80425-0167_2a99a670-af30-299d-e063-6294a90a05d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA204590
Marketing category
ANDA
Marketing start
2016-03-16
Substance
CELECOXIB
Active strength
100 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
2026-12-31
Current FDA listing
Yes

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
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 · 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 UTC2026-02A204590-001CELECOXIB50MGCAPSULE / 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…
2024-10-29 15:01 UTC2024-10A204590-001CELECOXIB50MGCAPSULE / ORALAB2016-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A204590-002CELECOXIB100MGCAPSULE / ORALAB2016-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A204590-003CELECOXIB200MGCAPSULE / ORALAB2016-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A204590-004CELECOXIB400MGCAPSULE / ORALAB2016-03-16d06236e962d9…

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 UTC2026-02A204590-001AB1011fe1cb6892…
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…
2024-10-29 15:01 UTC2024-10A204590-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204590-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204590-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204590-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JCX84Q7J1LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205322Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8ade384-2072-2cc2-e053-2a95a90ae791Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9aProduct name120200925
827beb42-45f2-95b8-6aa3-f35174375422Product name920160429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0167-1Celecoxib30 in 1 BOTTLECAPSULE307
80425-0167-2Celecoxib60 in 1 BOTTLECAPSULE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0167-1EA - Each80425-016738c85090-0fae-4c8a-a95f-f1159e081c5b12023-03-13
80425-0167-2EA - Each80425-0167e68c30fe-2235-428f-a756-dc3cc3db78a012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0167CELECOXIB CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_c8ade384-2072-2cc2-e053-2a95a90ae791.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 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
ndc (product): 80425-0167
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNc8ade384-2072-2cc2-e053-2a95a90ae7917
205322celecoxib 100 MG Oral CapsuleSCDc8ade384-2072-2cc2-e053-2a95a90ae7917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0167-18042501670130 CAPSULE in 1 BOTTLE (80425-0167-1) 30 capsule2016-03-160000-00-00NoNoCurrent
80425-0167-28042501670260 CAPSULE in 1 BOTTLE (80425-0167-2) 60 capsule2016-03-160000-00-00NoNoCurrent