Valsartan (Page 7 of 7)

Storage

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Valsartan

Label ImageLabel Image
VALSARTAN valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4130(NDC:33342-065)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN (VALSARTAN) VALSARTAN 320 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color GRAY (dark grey-violet) Score no score
Shape OVAL (oval shaped biconvex) Size 20mm
Flavor Imprint Code L15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4130-1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:50090-4130-0 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202696 09/19/2016
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4130), REPACK (50090-4130)

Revised: 06/2021 A-S Medication Solutions

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