FENOPROFEN CALCIUM

Product NDC
16571-688
11-digit product format
165710688
Labeler code
16571
Product ID
16571-688_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
2022-08-01
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
Rxcui197694, 197695, 858116

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0916fe0d-58e1-5e07-2471-9a804a1b0628Product name320240514
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
090af53b-bc54-1ac8-5eee-2f06b5d9cff9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-688-09FENOPROFEN CALCIUM90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-688-09EA - Each16571-688f3b6273e-c044-4272-bd84-f2a90e6ba73412022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-688FENOPROFEN CALCIUM CAPSULE [RISING PHARMA HOLDINGS, INC.]7Current NDC, Legacy 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
858116fenoprofen calcium 400 MG Oral CapsulePSN1d438989-6431-4c62-8f24-444475d423a31
858116fenoprofen 400 MG Oral CapsuleSCD1d438989-6431-4c62-8f24-444475d423a31
858116fenoprofen (as fenoprofen calcium) 400 MG Oral CapsuleSY1d438989-6431-4c62-8f24-444475d423a31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-688-091657106880990 CAPSULE in 1 BOTTLE (16571-688-09) 90 capsule2022-08-010000-00-00NoNoCurrent