FDA.reportPublic FDA data

CELECOXIB

Product NDC
50090-4789
11-digit product format
500904789
Labeler code
50090
Product ID
50090-4789_2bbd635f-76fa-4feb-9d3d-f84505d0e381
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204776
Marketing category
ANDA
Marketing start
2018-06-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CELECOXIB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205323

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4789-02023-02-07C16284748780-1f386c649-f269-0266-e053-dadaa90a7c1aThese 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
50090-4789-12023-02-07C16284748780-1f386c649-f269-0266-e053-dadaa90a7c1aThese 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
50090-4789-22023-02-07C16284748780-1f386c649-f269-0266-e053-dadaa90a7c1aThese 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
50090-4789-02023-01-30C16284748780-1f386c649-f269-0266-e053-dadaa90a7c1aThese 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
50090-4789-12023-01-30C16284748780-1f386c649-f269-0266-e053-dadaa90a7c1aThese 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
50090-4789-22023-01-30C16284748780-1f386c649-f269-0266-e053-dadaa90a7c1aThese 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
50090-4789-0CELECOXIB30 in 1 BOTTLECAPSULE309
50090-4789-1CELECOXIB60 in 1 BOTTLECAPSULE609
50090-4789-2CELECOXIB90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4789-0EA - Each50090-478978af8dcf-51f5-45c3-b2d6-d96d9efb1c9e12023-09-05
50090-4789-1EA - Each50090-47895150f0e2-a503-43d8-85d0-578e6094735c12023-09-05
50090-4789-2EA - Each50090-4789b24275e8-d69e-4868-a98d-355ed392d05112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4789CELECOXIB (CELECOXIB) CAPSULE [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20230825_00e67d5e-df6f-4dfd-8c2d-a001c8a99af0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN00e67d5e-df6f-4dfd-8c2d-a001c8a99af09
205323celecoxib 200 MG Oral CapsuleSCD00e67d5e-df6f-4dfd-8c2d-a001c8a99af09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4789-05009047890030 CAPSULE in 1 BOTTLE (50090-4789-0) 30 capsule2019-12-100000-00-00NoNoCurrent
50090-4789-15009047890160 CAPSULE in 1 BOTTLE (50090-4789-1) 60 capsule2019-12-100000-00-00NoNoCurrent
50090-4789-25009047890290 CAPSULE in 1 BOTTLE (50090-4789-2) 90 capsule2019-12-100000-00-00NoNoCurrent