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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0X2CW1QABJFENOPROFEN CALCIUM53746-45-5FENOPROFEN CALCIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-828-307120508283030 CAPSULE in 1 BOTTLE (71205-828-30) 30 capsule2023-08-15NoNoHistorical
71205-828-607120508286060 CAPSULE in 1 BOTTLE (71205-828-60) 60 capsule2023-08-15NoNoHistorical
71205-828-907120508289090 CAPSULE in 1 BOTTLE (71205-828-90) 90 capsule2023-08-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FENOPROFEN CALCIUMProficient Rx LP2023-08-01HUMAN PRESCRIPTION DRUG LABEL1