CELECOXIB

Product NDC
76282-693
Requested package NDC
76282-693-05
11-digit product format
762820693
Labeler code
76282
Product ID
76282-693_3c87c0ca-ac6b-40bf-8532-2f995faeceda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc
Application
ANDA207446
Marketing category
ANDA
Marketing start
2020-12-28
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
100 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 packagepackage76282-69376282-693-05IInactivated by FDA2026-08-11

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
A207446-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2015-09-23
A207446-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2015-09-23
A207446-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2015-09-23
A207446-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2015-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207446-001AB
A207446-002AB
A207446-003AB
A207446-004AB

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 UTC2026-02A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-23d06236e962d9…

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 UTC2026-02A207446-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207446-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207446-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-004AB1d06236e962d9…

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
76282-693-01CELECOXIB100 in 1 BOTTLECAPSULE1001
76282-693-05CELECOXIB500 in 1 BOTTLECAPSULE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-693CELECOXIB CAPSULE [EXELAN PHARMACEUTICALS, INC]1Legacy NDC, 2 package rows20201228_c96b34d6-52b5-4bd6-b7d0-93bf6380ef08.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELECOXIBCELECOXIBREMEDYREPACK INC.27f17ae7-939b-402e-9498-3b66111040892026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBNorthwind Health Company, LLCf874eddf-b2f3-6830-e053-6394a90ade7a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBNorthwind Health Company, LLCf2a0db9f-174b-1603-e053-2995a90a79a32026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBA-S Medication Solutions95b2ced1-eca2-4c25-aa10-c9fb86b353a32025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBA-S Medication Solutions7b8e923c-253f-461e-94d7-669e75dc73e92025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.3191c9dc-bfdf-0591-e054-00144ff8d46c2025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBQuallent Pharmaceuticals Health LLCaaa3a4f5-b281-415f-a08c-e0cefdae2fb52025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBCipla USA Inc.d12625b1-2af9-4532-af91-d40b65eeffef2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBNorthStar RxLLCce61a585-5ac0-4185-99eb-a9511cd25a982025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9d962a-5469-2039-e053-2a95a90ad59f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCc1abc73e-c6ab-a0a5-e053-2a95a90a08172024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBProficient Rx LPc91e5933-1798-4096-9f08-fb1200e154e12021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
205323celecoxib 200 MG Oral CapsulePSNc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
349514celecoxib 400 MG Oral CapsulePSNc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
686379celecoxib 50 MG Oral CapsulePSNc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
205322celecoxib 100 MG Oral CapsuleSCDc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
205323celecoxib 200 MG Oral CapsuleSCDc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
349514celecoxib 400 MG Oral CapsuleSCDc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
686379celecoxib 50 MG Oral CapsuleSCDc96b34d6-52b5-4bd6-b7d0-93bf6380ef081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-693-0576282069305500 CAPSULE in 1 BOTTLE (76282-693-05) 500 capsule2020-12-280000-00-00NoNoCurrent