IBUPROFEN AND FAMOTIDINE tablet

Ibuprofen and Famotidine by

Drug Labeling and Warnings

Ibuprofen and Famotidine by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

MEDICATION GUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen and famotidine tablets, 800 mg/26.6 mg

90 Tablets

NDC: 70771-1924-9

Rx only

INGREDIENTS AND APPEARANCE

IBUPROFEN AND FAMOTIDINE 
ibuprofen and famotidine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1924
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	800 mg
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	26.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to off-white)	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	777
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1924-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA218684	06/01/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (650199482)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1924) , MANUFACTURE(70771-1924)