Ketoprofen

Product NDC
52959-245
11-digit product format
529590245
Labeler code
52959
Product ID
52959-245_5fdf2c0a-67e1-44ca-9561-2caaf8d5ec9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA073516
Marketing category
ANDA
Marketing start
2011-01-18
Marketing end
0000-00-00
Substance
KETOPROFEN
Active strength
50 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-245-14Ketoprofen14 in 1 BOTTLECAPSULE142
52959-245-15Ketoprofen15 in 1 BOTTLECAPSULE152
52959-245-20Ketoprofen20 in 1 BOTTLECAPSULE202
52959-245-21Ketoprofen21 in 1 BOTTLECAPSULE212
52959-245-30Ketoprofen30 in 1 BOTTLECAPSULE302
52959-245-60Ketoprofen60 in 1 BOTTLECAPSULE602
52959-245-90Ketoprofen90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-245-14EA - Each52959-245ac4121d8-0679-4809-bdc4-5b58c097b85912012-07-24
52959-245-15EA - Each52959-24547bde6d1-dc5d-4a96-b91e-a5ffb359568a12012-07-24
52959-245-20EA - Each52959-245365db4b7-fc3c-4339-bf8c-64d6fb0a81b712012-07-24
52959-245-21EA - Each52959-2458f44d3f7-0e8c-4598-b082-cc489128e96012012-07-24
52959-245-30EA - Each52959-245da478c14-517a-4bb6-8d8e-0a149fdd87f012012-07-24
52959-245-60EA - Each52959-24570c1a335-8ca1-46d1-afc5-99ff5a8ae42812012-07-24
52959-245-90EA - Each52959-2452cdf56a4-079b-44c2-afcd-bc4ae8db83c912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOPROFENACTIVE INGREDIENT90Y4QC304KKETOPROFEN CAPSULE [H.J. HARKINS COMPANY, INC.]2
KETOPROFENACTIVE MOIETY90Y4QC304KKETOPROFEN CAPSULE [H.J. HARKINS COMPANY, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHKETOPROFEN CAPSULE [H.J. HARKINS COMPANY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKETOPROFEN CAPSULE [H.J. HARKINS COMPANY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LKETOPROFEN CAPSULE [H.J. HARKINS COMPANY, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GKETOPROFEN CAPSULE [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOPROFEN CAPSULE [H.J. HARKINS COMPANY, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKETOPROFEN CAPSULE [H.J. HARKINS COMPANY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOPROFEN CAPSULE [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-245KETOPROFEN CAPSULE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 7 package rows20111114_f9d258bc-2ae3-4cc8-a5d4-987164c1e0b4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-245-145295902451414 in 1 BOTTLEHistorical
52959-245-155295902451515 in 1 BOTTLEHistorical
52959-245-205295902452020 in 1 BOTTLEHistorical
52959-245-215295902452121 in 1 BOTTLEHistorical
52959-245-305295902453030 in 1 BOTTLEHistorical
52959-245-605295902456060 in 1 BOTTLEHistorical
52959-245-905295902459090 in 1 BOTTLEHistorical