Ketoprofen

Product NDC
33261-064
11-digit product format
332610064
Labeler code
33261
Product ID
33261-064_db694f6b-8c95-4f66-9b6e-5ab64d416abe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA073517
Marketing category
ANDA
Marketing start
1993-01-01
Marketing end
0000-00-00
Substance
KETOPROFEN
Active strength
75 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
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-064-60Ketoprofen60 in 1 BOTTLE, PLASTICCAPSULE601
33261-064-90Ketoprofen90 in 1 BOTTLE, PLASTICCAPSULE901
33261-064-97Ketoprofen126 in 1 BOTTLE, PLASTICCAPSULE1261

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-064-60EA - Each33261-06429c2df80-5237-40fb-9069-c258a61a2de512015-10-02
33261-064-90EA - Each33261-064ba200d4a-c72f-460a-b962-c8f886f3425412014-02-04
33261-064-97EA - Each33261-06432cabcc3-bb03-475b-bb98-958bc9c0b2aa12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOPROFENACTIVE INGREDIENT90Y4QC304KKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
KETOPROFENACTIVE MOIETY90Y4QC304KKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2KETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-064KETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140110_4bfd7816-73c1-49c4-833e-a8e5a6a7bd64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197856ketoprofen 75 MG Oral CapsulePSN4bfd7816-73c1-49c4-833e-a8e5a6a7bd641
197856ketoprofen 75 MG Oral CapsuleSCD4bfd7816-73c1-49c4-833e-a8e5a6a7bd641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-064-603326100646060 in 1 BOTTLE, PLASTICHistorical
33261-064-903326100649090 in 1 BOTTLE, PLASTICHistorical
33261-064-9733261006497126 in 1 BOTTLE, PLASTICHistorical