celecoxib

Product NDC
0615-8338
11-digit product format
006158338
Labeler code
0615
Product ID
0615-8338_efff08d1-657d-453a-96e9-08ca5a05288c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA202240
Marketing category
ANDA
Marketing start
2019-12-09
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-8338DDiscontinued by firm2026-08-17
excluded packagepackage0615-83380615-8338-39DDiscontinued by firm2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0615-8338DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-83380615-8338-39DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202240-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2014-10-29
A202240-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2015-06-09
A202240-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2015-06-09
A202240-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2015-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202240-001AB
A202240-002AB
A202240-003AB
A202240-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-09d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202240-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202240-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202240-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-004AB1d8e5a09893c0…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8338CELECOXIB CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]3Legacy NDC20241207_52311f40-fe10-408f-95c3-484c902d388a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
celecoxibCELECOXIBLupin Pharmaceuticals, Inc.560017b1-daf8-464e-b86f-0a75c78002ec2023-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202240
application number: ANDA202240
celecoxibCELECOXIBA-S Medication Solutions85bfe02b-bfcb-44ee-81a0-11765c3054a92023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202240
application number: ANDA202240

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8338-390061583383930 CAPSULE in 1 BLISTER PACK (0615-8338-39) 30 capsule2020-03-040000-00-00NoNoCurrent