FDA.reportPublic FDA data

Celecoxib

Product NDC
65162-820
11-digit product format
651620820
Labeler code
65162
Product ID
65162-820_bc256c1e-e9b9-4133-91b9-f03147f577bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA208833
Marketing category
ANDA
Marketing start
2018-06-25
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
400 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 productproduct65162-820DDiscontinued by firm2026-10-20
excluded packagepackage65162-82065162-820-06DDiscontinued by firm2026-10-20

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A208833-001CELECOXIBCELECOXIB50MGCAPSULE / ORAL2018-05-31
A208833-002CELECOXIBCELECOXIB100MGCAPSULE / ORAL2018-05-31
A208833-003CELECOXIBCELECOXIB200MGCAPSULE / ORAL2018-05-31
A208833-004CELECOXIBCELECOXIB400MGCAPSULE / ORAL2018-05-31

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A208833-001CELECOXIB50MGCAPSULE / ORAL2018-05-31c2088c7a36db…
2026-10-15 13:18:302026-09A208833-002CELECOXIB100MGCAPSULE / ORAL2018-05-31c2088c7a36db…
2026-10-15 13:18:302026-09A208833-003CELECOXIB200MGCAPSULE / ORAL2018-05-31c2088c7a36db…
2026-10-15 13:18:302026-09A208833-004CELECOXIB400MGCAPSULE / ORAL2018-05-31c2088c7a36db…
2026-09-14 22:38:342026-08A208833-001CELECOXIB50MGCAPSULE / ORAL2018-05-3184e616aacf4f…
2026-09-14 22:38:342026-08A208833-002CELECOXIB100MGCAPSULE / ORAL2018-05-3184e616aacf4f…
2026-09-14 22:38:342026-08A208833-003CELECOXIB200MGCAPSULE / ORAL2018-05-3184e616aacf4f…
2026-09-14 22:38:342026-08A208833-004CELECOXIB400MGCAPSULE / ORAL2018-05-3184e616aacf4f…
2026-08-18 06:07:402026-07A208833-001CELECOXIB50MGCAPSULE / ORAL2018-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07A208833-002CELECOXIB100MGCAPSULE / ORAL2018-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07A208833-003CELECOXIB200MGCAPSULE / ORAL2018-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07A208833-004CELECOXIB400MGCAPSULE / ORAL2018-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208833-001CELECOXIB50MGCAPSULE / ORAL2018-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208833-002CELECOXIB100MGCAPSULE / ORAL2018-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208833-003CELECOXIB200MGCAPSULE / ORAL2018-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208833-004CELECOXIB400MGCAPSULE / ORAL2018-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208833-001CELECOXIB50MGCAPSULE / ORAL2018-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208833-002CELECOXIB100MGCAPSULE / ORAL2018-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208833-003CELECOXIB200MGCAPSULE / ORAL2018-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208833-004CELECOXIB400MGCAPSULE / ORAL2018-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208833-001CELECOXIB50MGCAPSULE / ORAL2018-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208833-002CELECOXIB100MGCAPSULE / ORAL2018-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208833-003CELECOXIB200MGCAPSULE / ORAL2018-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208833-004CELECOXIB400MGCAPSULE / ORAL2018-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208833-001CELECOXIB50MGCAPSULE / ORAL2018-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208833-002CELECOXIB100MGCAPSULE / ORAL2018-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208833-003CELECOXIB200MGCAPSULE / ORAL2018-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208833-004CELECOXIB400MGCAPSULE / ORAL2018-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208833-001CELECOXIB50MGCAPSULE / ORAL2018-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208833-002CELECOXIB100MGCAPSULE / ORAL2018-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208833-003CELECOXIB200MGCAPSULE / ORAL2018-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208833-004CELECOXIB400MGCAPSULE / ORAL2018-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208833-001CELECOXIB50MGCAPSULE / ORAL2018-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208833-002CELECOXIB100MGCAPSULE / ORAL2018-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208833-003CELECOXIB200MGCAPSULE / ORAL2018-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208833-004CELECOXIB400MGCAPSULE / ORAL2018-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208833-001CELECOXIB50MGCAPSULE / ORAL2018-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208833-002CELECOXIB100MGCAPSULE / ORAL2018-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208833-003CELECOXIB200MGCAPSULE / ORAL2018-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208833-004CELECOXIB400MGCAPSULE / ORAL2018-05-312680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208833-001BX16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208833-002BX16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208833-003BX16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208833-004BX16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208833-001BX11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A208833-002BX11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A208833-003BX11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A208833-004BX11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208833-001BX1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A208833-002BX1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A208833-003BX1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A208833-004BX1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208833-001BX1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208833-002BX1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208833-003BX1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208833-004BX1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208833-001BX19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208833-002BX19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208833-003BX19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208833-004BX19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208833-001BX1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208833-002BX1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208833-003BX1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208833-004BX1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208833-001BX13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208833-002BX13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208833-003BX13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208833-004BX13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208833-001BX1053a50430f4f…
2023-05-13 08:27 UTC2023-05A208833-002BX1053a50430f4f…
2023-05-13 08:27 UTC2023-05A208833-003BX1053a50430f4f…
2023-05-13 08:27 UTC2023-05A208833-004BX1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208833-001BX13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A208833-002BX13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A208833-003BX13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A208833-004BX13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208833-001BX13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208833-002BX13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208833-003BX13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208833-004BX13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-820CELECOXIB CAPSULE [AMNEAL PHARMACEUTICALS LLC]14Legacy NDC20250107_237ea981-d1f7-498d-8d3a-37599a763c66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-820-066516208200660 CAPSULE in 1 BOTTLE (65162-820-06) 60 capsule2018-06-250000-00-00NoNoCurrent