Ketoprofen

Product NDC
45865-485
11-digit product format
458650485
Labeler code
45865
Product ID
45865-485_7176c8c1-1fc8-88c1-e053-2a95a90a89f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA073516
Marketing category
ANDA
Marketing start
1993-01-01
Marketing end
0000-00-00
Substance
KETOPROFEN
Active strength
50 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
2020-12-31
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
45865-485-30Ketoprofen30 in 1 BOTTLECAPSULE301
45865-485-51Ketoprofen120 in 1 BOTTLECAPSULE1201
45865-485-60Ketoprofen60 in 1 BOTTLECAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-485KETOPROFEN CAPSULE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 3 package rows20180723_71770241-8e44-c120-e053-2a95a90a107b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197855ketoprofen 50 MG Oral CapsulePSN71770241-8e44-c120-e053-2a95a90a107b1
197855ketoprofen 50 MG Oral CapsuleSCD71770241-8e44-c120-e053-2a95a90a107b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-485-304586504853030 CAPSULE in 1 BOTTLE (45865-485-30) 30 capsule2018-01-010000-00-00NoNoCurrent
45865-485-5145865048551120 CAPSULE in 1 BOTTLE (45865-485-51) 120 capsule2018-01-010000-00-00NoNoCurrent
45865-485-604586504856060 CAPSULE in 1 BOTTLE (45865-485-60) 60 capsule2018-01-010000-00-00NoNoCurrent