FENOPROFEN CALCIUM

Product NDC
71993-308
11-digit product format
719930308
Labeler code
71993
Product ID
71993-308_14a4aa5b-30ff-8ad7-e063-6294a90a889e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOPROFEN CALCIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Atland Pharmaceuticals, LLC
Application
ANDA214475
Marketing category
ANDA
Marketing start
2024-03-26
Substance
FENOPROFEN CALCIUM
Active strength
400 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FENOPROFEN CALCIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOPROFEN CALCIUM400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0X2CW1QABJ
Rxcui858116

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
71993-308-90FENOPROFEN CALCIUM90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71993-308-90EA - Each71993-308857fbce2-83e2-44e7-8661-0d0c53de883c12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71993-308FENOPROFEN CALCIUM CAPSULE [ATLAND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20240328_3daa336f-2acf-4109-a360-b1d30b192d41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858116fenoprofen calcium 400 MG Oral CapsulePSN3daa336f-2acf-4109-a360-b1d30b192d411
858116fenoprofen 400 MG Oral CapsuleSCD3daa336f-2acf-4109-a360-b1d30b192d411
858116fenoprofen (as fenoprofen calcium) 400 MG Oral CapsuleSY3daa336f-2acf-4109-a360-b1d30b192d411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71993-308-907199303089090 CAPSULE in 1 BOTTLE (71993-308-90) 90 capsule2024-03-26NoNoHistorical