Ibuprofen

Product NDC
63941-680
11-digit product format
639410680
Labeler code
63941
Product ID
63941-680_06d34c06-f0eb-0825-e063-6394a90ae0c9
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
ANDA078682
Marketing category
ANDA
Marketing start
2023-10-05
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
63941-680-11639410680111 BOTTLE in 1 CARTON (63941-680-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2023-10-05NoNoHistorical
63941-680-78639410680781 BOTTLE in 1 CARTON (63941-680-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2023-10-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen Capsules, 200 mgVALU MERCHANDISERS COMPANY | Bionpharma Inc. | Patheon Softgels Inc.2023-10-05HUMAN OTC DRUG LABEL2