FDA.reportPublic FDA data

Ketoprofen

Product NDC
42254-037
11-digit product format
422540037
Labeler code
42254
Product ID
42254-037_51f3222f-bc05-4117-881d-85880b092e42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA073517
Marketing category
ANDA
Marketing start
2011-01-18
Marketing end
0000-00-00
Substance
KETOPROFEN
Active strength
75 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
460c0bb5-c2b5-c96e-0f79-68a0385a39a0Product name220201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-037-302019-09-24C16284748780-19350213a-3c56-c013-e053-90daa90a1393KETOPROFEN CAPSULES Rx only
42254-037-602019-09-24C16284748780-19350213a-3c56-c013-e053-90daa90a1393KETOPROFEN CAPSULES Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-037-30Ketoprofen30 in 1 BOTTLECAPSULE301
42254-037-60Ketoprofen60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-037-30EA - Each42254-037fb086e82-1e0a-4ea4-9b65-ad7aef5e612712012-07-24
42254-037-60EA - Each42254-037f88e7dfe-0885-4744-8a61-9c0bf754632112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOPROFENACTIVE INGREDIENT90Y4QC304KKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
KETOPROFENACTIVE MOIETY90Y4QC304KKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-037KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120420_51f3222f-bc05-4117-881d-85880b092e42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197856ketoprofen 75 MG Oral CapsulePSN51f3222f-bc05-4117-881d-85880b092e421
197856ketoprofen 75 MG Oral CapsuleSCD51f3222f-bc05-4117-881d-85880b092e421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-037-304225400373030 in 1 BOTTLEHistorical
42254-037-604225400376060 in 1 BOTTLEHistorical