CELECOXIB

Product NDC
68071-2626
11-digit product format
680712626
Labeler code
68071
Product ID
68071-2626_d61d3545-f90a-85c1-e053-2995a90aff61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210628
Marketing category
ANDA
Marketing start
2020-09-03
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2626IInactivated by FDA2026-08-07
excluded packagepackage68071-262668071-2626-3IInactivated by FDA2026-08-07

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2626-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2626-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2626-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2626-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2626-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2626-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2626-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2626-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2626-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-2626-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-2626-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-2626-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-2626-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-2626-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-2626-31332a3947898…d4bfe170f9cd…

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
A210628-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2019-11-27
A210628-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2019-11-27
A210628-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2019-11-27
A210628-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2019-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210628-001AB
A210628-002AB
A210628-003AB
A210628-004AB

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 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210628-001CELECOXIB50MGCAPSULE / ORALAB2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210628-002CELECOXIB100MGCAPSULE / ORALAB2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210628-003CELECOXIB200MGCAPSULE / ORALAB2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210628-004CELECOXIB400MGCAPSULE / ORALAB2019-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210628-001CELECOXIB50MGCAPSULE / ORALAB2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210628-002CELECOXIB100MGCAPSULE / ORALAB2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210628-003CELECOXIB200MGCAPSULE / ORALAB2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210628-004CELECOXIB400MGCAPSULE / ORALAB2019-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210628-001CELECOXIB50MGCAPSULE / ORALAB2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210628-002CELECOXIB100MGCAPSULE / ORALAB2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210628-003CELECOXIB200MGCAPSULE / ORALAB2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210628-004CELECOXIB400MGCAPSULE / ORALAB2019-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210628-001CELECOXIB50MGCAPSULE / ORALAB2019-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210628-002CELECOXIB100MGCAPSULE / ORALAB2019-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210628-003CELECOXIB200MGCAPSULE / ORALAB2019-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210628-004CELECOXIB400MGCAPSULE / ORALAB2019-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210628-001CELECOXIB50MGCAPSULE / ORALAB2019-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210628-002CELECOXIB100MGCAPSULE / ORALAB2019-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210628-003CELECOXIB200MGCAPSULE / ORALAB2019-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210628-004CELECOXIB400MGCAPSULE / ORALAB2019-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210628-001CELECOXIB50MGCAPSULE / ORALAB2019-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210628-002CELECOXIB100MGCAPSULE / ORALAB2019-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210628-003CELECOXIB200MGCAPSULE / ORALAB2019-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210628-004CELECOXIB400MGCAPSULE / ORALAB2019-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210628-001CELECOXIB50MGCAPSULE / ORALAB2019-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210628-002CELECOXIB100MGCAPSULE / ORALAB2019-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210628-003CELECOXIB200MGCAPSULE / ORALAB2019-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210628-004CELECOXIB400MGCAPSULE / ORALAB2019-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210628-001CELECOXIB50MGCAPSULE / ORALAB2019-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210628-002CELECOXIB100MGCAPSULE / ORALAB2019-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210628-003CELECOXIB200MGCAPSULE / ORALAB2019-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210628-004CELECOXIB400MGCAPSULE / ORALAB2019-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210628-001CELECOXIB50MGCAPSULE / ORALAB2019-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210628-002CELECOXIB100MGCAPSULE / ORALAB2019-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210628-003CELECOXIB200MGCAPSULE / ORALAB2019-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210628-004CELECOXIB400MGCAPSULE / ORALAB2019-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210628-001CELECOXIB50MGCAPSULE / ORALAB2019-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A210628-002CELECOXIB100MGCAPSULE / ORALAB2019-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A210628-003CELECOXIB200MGCAPSULE / ORALAB2019-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A210628-004CELECOXIB400MGCAPSULE / ORALAB2019-11-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210628-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210628-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210628-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210628-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210628-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210628-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210628-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210628-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210628-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210628-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210628-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210628-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210628-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210628-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210628-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210628-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210628-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210628-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210628-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210628-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210628-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210628-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210628-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210628-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210628-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210628-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210628-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210628-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210628-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210628-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210628-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210628-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210628-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210628-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210628-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210628-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210628-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210628-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210628-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210628-004AB1d06236e962d9…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2626-3CELECOXIB30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2626CELECOXIB CAPSULE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220123_d61d3658-5138-4fba-e053-2995a90ae525.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELECOXIBCELECOXIBBryant Ranch Prepackfd569104-8243-48fa-8e93-5a08654ad6dd2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210628
application number: ANDA210628
CELECOXIBCELECOXIBREMEDYREPACK INC.d0ca85fa-8b80-4a48-a1a4-a1c181821c392026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210628
application number: ANDA210628
CELECOXIBCELECOXIBBryant Ranch Prepack47be1d99-eebb-42f9-80d9-291a024b13642026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210628
application number: ANDA210628
CELECOXIBCELECOXIBUmedica Laboratories USA Inc.b0e0243e-59b3-4f73-8c21-86b60fc7894b2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210628
application number: ANDA210628
CELECOXIBCELECOXIBNIVAGEN PHARMACEUTICALS, INC.ae7943ab-b1fc-f08f-e053-2995a90a051e2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210628
application number: ANDA210628
CELECOXIBCELECOXIBPHOENIX RX LLC3a669c28-fbc7-827c-e063-6394a90a08292025-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210628
application number: ANDA210628
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf60394f5-fd69-929b-e053-2995a90a57932024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210628
application number: ANDA210628

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNd61d3658-5138-4fba-e053-2995a90ae5251
205323celecoxib 200 MG Oral CapsuleSCDd61d3658-5138-4fba-e053-2995a90ae5251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2626-36807126260330 CAPSULE in 1 BOTTLE (68071-2626-3) 30 capsule2022-01-210000-00-00NoNoCurrent