Ibuprofen

Product NDC
68071-3696
11-digit product format
680713696
Labeler code
68071
Product ID
68071-3696_23fafe2b-6563-60a0-e063-6394a90af87a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA213794
Marketing category
ANDA
Marketing start
2020-05-08
Substance
IBUPROFEN
Active strength
800 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
68071-3696-868071369608180 TABLET in 1 BOTTLE (68071-3696-8) 180 tablet2024-10-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen Tablets, USP Rx onlyNuCare Pharmaceuticals, Inc.2024-10-08HUMAN PRESCRIPTION DRUG LABEL1