Ketoprofen

Product NDC
21695-341
11-digit product format
216950341
Labeler code
21695
Product ID
21695-341_9bc31f67-cfce-4ad6-9c07-3845ead3542c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074035
Marketing category
ANDA
Marketing start
2010-04-20
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
21695-341-212019-09-24C16284748780-1934fe258-4ba5-48b1-e053-8cdaa90a720aKetoprofen
21695-341-302019-09-24C16284748780-1934fe258-4ba5-48b1-e053-8cdaa90a720aKetoprofen
21695-341-422019-09-24C16284748780-1934fe258-4ba5-48b1-e053-8cdaa90a720aKetoprofen
21695-341-602019-09-24C16284748780-1934fe258-4ba5-48b1-e053-8cdaa90a720aKetoprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-341-21Ketoprofen21 in 1 BOTTLECAPSULE211
21695-341-30Ketoprofen30 in 1 BOTTLECAPSULE301
21695-341-42Ketoprofen42 in 1 BOTTLECAPSULE421
21695-341-60Ketoprofen60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-341-21EA - Each21695-3414a298dbe-6507-4abb-82a1-49e88dd7242712012-07-24
21695-341-30EA - Each21695-341b3ee56bc-3522-46cd-97b0-59fb14362b0312012-07-24
21695-341-42EA - Each21695-341e5d66984-66ee-42fb-917d-cfb69c5f3c9612012-07-24
21695-341-60EA - Each21695-341a53fb53b-c7b3-485f-aaf4-cd42ca91cb7612012-07-24

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 YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKETOPROFEN 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
21695-341KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20110104_9bc31f67-cfce-4ad6-9c07-3845ead3542c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197855ketoprofen 50 MG Oral CapsulePSN9bc31f67-cfce-4ad6-9c07-3845ead3542c1
197856ketoprofen 75 MG Oral CapsulePSN9bc31f67-cfce-4ad6-9c07-3845ead3542c1
197855ketoprofen 50 MG Oral CapsuleSCD9bc31f67-cfce-4ad6-9c07-3845ead3542c1
197856ketoprofen 75 MG Oral CapsuleSCD9bc31f67-cfce-4ad6-9c07-3845ead3542c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-341-212169503412121 in 1 BOTTLEHistorical
21695-341-302169503413030 in 1 BOTTLEHistorical
21695-341-422169503414242 in 1 BOTTLEHistorical
21695-341-602169503416060 in 1 BOTTLEHistorical