FENOPROFEN CALCIUM

Product NDC
16571-887
11-digit product format
165710887
Labeler code
16571
Product ID
16571-887_ba5e0066-40c5-4ea4-bd0c-cfcb18bdbc48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOPROFEN CALCIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA214475
Marketing category
ANDA
Marketing start
2024-07-26
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
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 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
16571-887-01FENOPROFEN CALCIUM100 in 1 BOTTLECAPSULE1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-887FENOPROFEN CALCIUM CAPSULE [RISING PHARMA HOLDINGS, INC.]7Current NDC, 1 package rows20241211_4aa38cca-9f8f-4ab6-8103-4f1f48801a43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197694fenoprofen calcium 200 MG Oral CapsulePSN4aa38cca-9f8f-4ab6-8103-4f1f48801a438
197695fenoprofen calcium 300 MG Oral CapsulePSN4aa38cca-9f8f-4ab6-8103-4f1f48801a438
858116fenoprofen calcium 400 MG Oral CapsulePSN4aa38cca-9f8f-4ab6-8103-4f1f48801a438
197694fenoprofen 200 MG Oral CapsuleSCD4aa38cca-9f8f-4ab6-8103-4f1f48801a438
197695fenoprofen 300 MG Oral CapsuleSCD4aa38cca-9f8f-4ab6-8103-4f1f48801a438
858116fenoprofen 400 MG Oral CapsuleSCD4aa38cca-9f8f-4ab6-8103-4f1f48801a438
197694fenoprofen (as fenoprofen calcium) 200 MG Oral CapsuleSY4aa38cca-9f8f-4ab6-8103-4f1f48801a438
197695fenoprofen (as fenoprofen calcium) 300 MG Oral CapsuleSY4aa38cca-9f8f-4ab6-8103-4f1f48801a438
858116fenoprofen (as fenoprofen calcium) 400 MG Oral CapsuleSY4aa38cca-9f8f-4ab6-8103-4f1f48801a438

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-887-0116571088701100 CAPSULE in 1 BOTTLE (16571-887-01) 100 capsule2024-07-26NoNoHistorical