CELECOXIB

Product NDC
70518-3292
11-digit product format
705183292
Labeler code
70518
Product ID
70518-3292_d7bfa8e7-728f-b1a4-e053-2a95a90af521
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210628
Marketing category
ANDA
Marketing start
2021-12-13
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-3292DDiscontinued by firm2026-08-03
excluded packagepackage70518-329270518-3292-0DDiscontinued by firm2026-08-03
excluded packagepackage70518-329270518-3292-1DDiscontinued by firm2026-08-03
excluded packagepackage70518-329270518-3292-2DDiscontinued by firm2026-08-03
excluded packagepackage70518-329270518-3292-3DDiscontinued by firm2026-08-03

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 · 38 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 packagepackage70518-3292-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3292-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3292-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3292-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3292-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3292-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3292-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3292-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3292-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3292-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3292-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3292-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3292-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3292-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3292-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3292-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3292-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3292-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3292-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3292-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3292-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3292-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3292-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3292-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3292-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3292-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3292-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3292-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3292-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3292-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-3292-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-3292-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-3292-2367a005e9d99…383a685ebd0f…

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3292CELECOXIB CAPSULE [REMEDYREPACK INC.]9Legacy NDC20250308_8c4b224e-7227-426c-98f3-33b9b7324e84.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3292-07051832920090 CAPSULE in 1 BOTTLE, PLASTIC (70518-3292-0) 90 capsule2021-12-130000-00-00NoNoCurrent
70518-3292-17051832920130 CAPSULE in 1 BOTTLE, PLASTIC (70518-3292-1) 30 capsule2021-12-280000-00-00NoNoCurrent
70518-3292-27051832920260 CAPSULE in 1 BOTTLE, PLASTIC (70518-3292-2) 60 capsule2022-02-030000-00-00NoNoCurrent