FDA.reportPublic FDA data

FENOPROFEN CALCIUM

Product NDC
71205-828
11-digit product format
712050828
Labeler code
71205
Product ID
71205-828_1d438989-6431-4c62-8f24-444475d423a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOPROFEN CALCIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
Rxcui858116

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
71205-828-30FENOPROFEN CALCIUM30 in 1 BOTTLECAPSULE301
71205-828-60FENOPROFEN CALCIUM60 in 1 BOTTLECAPSULE601
71205-828-90FENOPROFEN CALCIUM90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-828-90EA - Each71205-82825e09be0-6988-4773-989f-16814744a60c12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-828FENOPROFEN CALCIUM CAPSULE [PROFICIENT RX LP]1Current NDC, 3 package rows20230819_1d438989-6431-4c62-8f24-444475d423a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
71205-828-307120508283030 CAPSULE in 1 BOTTLE (71205-828-30) 30 capsule2023-08-15NoNoCurrent
71205-828-607120508286060 CAPSULE in 1 BOTTLE (71205-828-60) 60 capsule2023-08-15NoNoCurrent
71205-828-907120508289090 CAPSULE in 1 BOTTLE (71205-828-90) 90 capsule2023-08-15NoNoCurrent