Ketoprofen

Product NDC
0276-0504
11-digit product format
002760504
Labeler code
0276
Product ID
0276-0504_4add4a71-ad1b-2577-e063-6294a90a3263
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Misemer Pharmaceuticals, Inc.
Application
ANDA074014
Marketing category
ANDA
Marketing start
2019-06-19
Substance
KETOPROFEN
Active strength
25 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ketoprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOPROFEN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii90Y4QC304K
Rxcui197854, 197855, 197856

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
0276-0504-102024-02-01C16284748780-11030e365-5724-111a-e063-dadaa90a10e2KETOPROFEN CAPSULES USP
0276-0504-102024-01-30C16284748780-11030e365-5724-111a-e063-dadaa90a10e2KETOPROFEN CAPSULES USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0276-0504-10Ketoprofen100 in 1 BOTTLECAPSULE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0276-0504-10EA - Each0276-0504b76d087e-0eca-455a-95b7-7f660e6220cc12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0276-0504KETOPROFEN CAPSULE [MISEMER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20240731_d0f47ab6-29ff-df07-e053-2a95a90a2b51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197854ketoprofen 25 MG Oral CapsulePSNd0f47ab6-29ff-df07-e053-2a95a90a2b5111
197855ketoprofen 50 MG Oral CapsulePSNd0f47ab6-29ff-df07-e053-2a95a90a2b5111
197856ketoprofen 75 MG Oral CapsulePSNd0f47ab6-29ff-df07-e053-2a95a90a2b5111
197854ketoprofen 25 MG Oral CapsuleSCDd0f47ab6-29ff-df07-e053-2a95a90a2b5111
197855ketoprofen 50 MG Oral CapsuleSCDd0f47ab6-29ff-df07-e053-2a95a90a2b5111
197856ketoprofen 75 MG Oral CapsuleSCDd0f47ab6-29ff-df07-e053-2a95a90a2b5111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0276-0504-1000276050410100 CAPSULE in 1 BOTTLE (0276-0504-10) 100 capsule2021-11-010000-00-00NoNoCurrent