Ketoprofen

Product NDC
45865-379
11-digit product format
458650379
Labeler code
45865
Product ID
45865-379_715dddb1-dad7-2c39-e053-2995a90a9ee7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
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
45865-379-30Ketoprofen30 in 1 BOTTLECAPSULE308
45865-379-60Ketoprofen60 in 1 BOTTLECAPSULE608
45865-379-90Ketoprofen90 in 1 BOTTLECAPSULE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-379KETOPROFEN CAPSULE [MEDSOURCE PHARMACEUTICALS]8Legacy NDC, 3 package rows20180719_715dddb1-dad6-2c39-e053-2995a90a9ee7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197856ketoprofen 75 MG Oral CapsulePSN715dddb1-dad6-2c39-e053-2995a90a9ee78
197856ketoprofen 75 MG Oral CapsuleSCD715dddb1-dad6-2c39-e053-2995a90a9ee78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-379-304586503793030 in 1 BOTTLEHistorical
45865-379-604586503796060 in 1 BOTTLEHistorical
45865-379-904586503799090 in 1 BOTTLEHistorical