CELECOXIB

Product NDC
53002-2338
Requested package NDC
53002-2338-2
11-digit product format
530022338
Labeler code
53002
Product ID
53002-2338_378dface-e55a-4b77-a14e-26a9b9d18f03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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
2021-12-31
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 packagepackage53002-233853002-2338-2IInactivated 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 · 9 matching rows.

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

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

NDC, Effective, Related label table
NDCEffectiveRelated label
53002-2338-12025-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
53002-2338-22025-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
53002-2338-32025-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
53002-2338-12023-06-08These highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
53002-2338-22023-06-08These highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
53002-2338-32023-06-08These highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
53002-2338-12023-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
53002-2338-22023-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
53002-2338-32023-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2338-1CELECOXIB10 in 1 BOTTLECAPSULE103
53002-2338-2CELECOXIB20 in 1 BOTTLECAPSULE203
53002-2338-3CELECOXIB30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2338CELECOXIB (CELECOXIB) CAPSULE [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20230609_65cb4362-f034-406e-a118-a09cfd44e2da.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 CapsulePSN65cb4362-f034-406e-a118-a09cfd44e2da3
205323celecoxib 200 MG Oral CapsuleSCD65cb4362-f034-406e-a118-a09cfd44e2da3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2338-25300223380220 CAPSULE in 1 BOTTLE (53002-2338-2) 20 capsule2019-01-010000-00-00NoNoCurrent