Fenoprofen Calcium

Product NDC
0276-0502
11-digit product format
002760502
Labeler code
0276
Product ID
0276-0502_4fa9e651-402e-420b-e063-6294a90a7dc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenoprofen Calcium
Dosage form
CAPSULE
Route
ORAL
Labeler
Misemer Pharmaceuticals, Inc.
Application
NDA017604
Marketing category
NDA
Marketing start
2021-11-01
Substance
FENOPROFEN CALCIUM
Active strength
300 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
Fenoprofen Calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOPROFEN CALCIUM300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0X2CW1QABJ
Rxcui197694, 197695, 858116

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0916fe0d-58e1-5e07-2471-9a804a1b0628Product name320240514
090af53b-bc54-1ac8-5eee-2f06b5d9cff9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0276-0502-10Fenoprofen Calcium100 in 1 BOTTLECAPSULE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0276-0502FENOPROFEN CALCIUM CAPSULE [MISEMER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20250206_d33ad329-1ca6-ac2e-e053-2995a90a15c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197694fenoprofen calcium 200 MG Oral CapsulePSNd33ad329-1ca6-ac2e-e053-2995a90a15c55
197695fenoprofen calcium 300 MG Oral CapsulePSNd33ad329-1ca6-ac2e-e053-2995a90a15c55
858116fenoprofen calcium 400 MG Oral CapsulePSNd33ad329-1ca6-ac2e-e053-2995a90a15c55
197694fenoprofen 200 MG Oral CapsuleSCDd33ad329-1ca6-ac2e-e053-2995a90a15c55
197695fenoprofen 300 MG Oral CapsuleSCDd33ad329-1ca6-ac2e-e053-2995a90a15c55
858116fenoprofen 400 MG Oral CapsuleSCDd33ad329-1ca6-ac2e-e053-2995a90a15c55
197694fenoprofen (as fenoprofen calcium) 200 MG Oral CapsuleSYd33ad329-1ca6-ac2e-e053-2995a90a15c55
197695fenoprofen (as fenoprofen calcium) 300 MG Oral CapsuleSYd33ad329-1ca6-ac2e-e053-2995a90a15c55
858116fenoprofen (as fenoprofen calcium) 400 MG Oral CapsuleSYd33ad329-1ca6-ac2e-e053-2995a90a15c55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0276-0502-1000276050210100 CAPSULE in 1 BOTTLE (0276-0502-10) 100 capsule2021-11-010000-00-00NoNoCurrent