ibuprofen

Product NDC
71335-1911
11-digit product format
713351911
Labeler code
71335
Product ID
71335-1911_97810365-78c2-4332-87e7-c873715fea15
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA072096
Marketing category
ANDA
Marketing start
2018-09-20
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

Additional Listing Data

Finished product
Yes
Brand name base
ibuprofen
Listing expiration
2026-12-31

Related Records

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers

FieldValues
UniiWK2XYI10QM
Rxcui310965

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WK2XYI10QMIBUPROFEN15687-27-1IBUPROFEN

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1911-07133519110090 TABLET, FILM COATED in 1 BOTTLE (71335-1911-0) 2021-07-150000-00-00NoNoCurrent
71335-1911-17133519110120 TABLET, FILM COATED in 1 BOTTLE (71335-1911-1) 2021-07-150000-00-00NoNoCurrent
71335-1911-27133519110215 TABLET, FILM COATED in 1 BOTTLE (71335-1911-2) 2021-07-150000-00-00NoNoCurrent
71335-1911-37133519110330 TABLET, FILM COATED in 1 BOTTLE (71335-1911-3) 2021-07-150000-00-00NoNoCurrent
71335-1911-471335191104100 TABLET, FILM COATED in 1 BOTTLE (71335-1911-4) 2021-07-150000-00-00NoNoCurrent
71335-1911-57133519110560 TABLET, FILM COATED in 1 BOTTLE (71335-1911-5) 2021-07-150000-00-00NoNoCurrent
71335-1911-67133519110650 TABLET, FILM COATED in 1 BOTTLE (71335-1911-6) 2021-07-150000-00-00NoNoCurrent
71335-1911-77133519110740 TABLET, FILM COATED in 1 BOTTLE (71335-1911-7) 2021-07-150000-00-00NoNoCurrent
71335-1911-87133519110810 TABLET, FILM COATED in 1 BOTTLE (71335-1911-8) 2021-07-150000-00-00NoNoCurrent
71335-1911-97133519110956 TABLET, FILM COATED in 1 BOTTLE (71335-1911-9) 2021-07-150000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Major Pharmaceuticals Ibuprofen Drug FactsBryant Ranch Prepack2024-07-12HUMAN OTC DRUG LABEL103