FDA.reportPublic FDA data

celecoxib

Product NDC
50090-5638
11-digit product format
500905638
Labeler code
50090
Product ID
50090-5638_0d540a4e-27a4-4acc-b51c-5e6f9873dded
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202240
Marketing category
ANDA
Marketing start
2019-12-09
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
50090-5638-02023-02-06C16284748780-1f386c649-d4ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5638-12023-02-06C16284748780-1f386c649-d4ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5638-22023-02-06C16284748780-1f386c649-d4ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5638-02023-01-30C16284748780-1f386c649-d4ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5638-12023-01-30C16284748780-1f386c649-d4ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5638-22023-01-30C16284748780-1f386c649-d4ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5638-0celecoxib30 in 1 BOTTLECAPSULE303
50090-5638-1celecoxib60 in 1 BOTTLECAPSULE603
50090-5638-2celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5638-0EA - Each50090-5638c7b779e3-376b-4495-abf0-1fb64e1af60b12022-12-07
50090-5638-1EA - Each50090-56382d279b38-b9c8-4d1b-b811-802ee0f6258f12022-10-06
50090-5638-2EA - Each50090-56386f99e486-6fc4-4010-8991-4d2d57243ceb12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5638CELECOXIB CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 3 package rows20230208_85bfe02b-bfcb-44ee-81a0-11765c3054a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN85bfe02b-bfcb-44ee-81a0-11765c3054a93
205323celecoxib 200 MG Oral CapsuleSCD85bfe02b-bfcb-44ee-81a0-11765c3054a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5638-05009056380030 CAPSULE in 1 BOTTLE (50090-5638-0) 30 capsule2021-09-030000-00-00NoNoCurrent
50090-5638-15009056380160 CAPSULE in 1 BOTTLE (50090-5638-1) 60 capsule2021-09-030000-00-00NoNoCurrent
50090-5638-25009056380290 CAPSULE in 1 BOTTLE (50090-5638-2) 90 capsule2021-09-090000-00-00NoNoCurrent