PROPRINAL

Product NDC
50090-3507
11-digit product format
500903507
Labeler code
50090
Product ID
50090-3507_4ed90335-efbd-499b-88ca-a39348b8e13d
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen Capsules 200 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079205
Marketing category
ANDA
Marketing start
2017-01-11
Substance
IBUPROFEN
Active strength
200 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
WK2XYI10QMIBUPROFEN15687-27-1IBUPROFEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-3507-050090350700300 PACKET in 1 BOX (50090-3507-0) / 2 CAPSULE, LIQUID FILLED in 1 PACKET300 packet2018-07-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PROPRINALA-S Medication Solutions2024-01-29HUMAN OTC DRUG LABEL1