CELECOXIB

Product NDC
45865-970
11-digit product format
458650970
Labeler code
45865
Product ID
45865-970_9af06651-d73c-2269-e053-2a95a90a1c56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA204776
Marketing category
ANDA
Marketing start
2018-06-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45865-970IInactivated by FDA2026-08-03
excluded packagepackage45865-97045865-970-30IInactivated by FDA2026-08-03

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-970-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-970-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-970-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-970-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-970-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-970-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-970-30UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-970-30UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-970-30UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A204776-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2018-04-30
A204776-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2018-04-30
A204776-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2018-04-30
A204776-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204776-001AB
A204776-002AB
A204776-003AB
A204776-004AB

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 UTC2026-02A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30d06236e962d9…

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 UTC2026-02A204776-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204776-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204776-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-004AB1d06236e962d9…

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
45865-970-30CELECOXIB30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-970CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191231_9af06651-d73b-2269-e053-2a95a90a1c56.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELECOXIBCELECOXIBAmerican Health Packaging4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc72026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBNorthwind Health Company, LLCdabfb290-0a7f-3429-e053-2a95a90ae04c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBNorthwind Health Company, LLCdac05189-4acf-d6bb-e053-2a95a90a46a92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBMicro Labs Limited408b30d6-f5c2-4239-b993-d8f77a8e160b2025-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBBryant Ranch Prepack550c828b-8c88-4c47-a7b8-a436aed46dc72025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBBryant Ranch Prepackdeeecba5-7a76-444b-a891-b00b1fb16d512025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9da1f2-717b-32b6-e053-2995a90ae5852024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBProficient Rx LP1071fcb5-0e9f-4e30-8fb4-df76fd876fe82024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBBryant Ranch Prepack627abea5-e39a-4e4f-b1ab-4842ed8112e92024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBA-S Medication Solutions00e67d5e-df6f-4dfd-8c2d-a001c8a99af02023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBA-S Medication Solutionsc7a183dc-f4d5-483f-964c-f2745a3640ad2023-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN9af06651-d73b-2269-e053-2a95a90a1c561
205323celecoxib 200 MG Oral CapsuleSCD9af06651-d73b-2269-e053-2a95a90a1c561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-970-304586509703030 CAPSULE in 1 BOTTLE (45865-970-30) 30 capsule2019-12-110000-00-00NoNoCurrent