NDC 0179-0173-80
API & Excipient Details

Dicyclomine Hydrochloride marketed by KAISER FOUNDATION HOSPITALS under NDC Code 0179-0173-80

NDC Code(s) : 0179-0173-80
Packager : KAISER FOUNDATION HOSPITALS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

dicyclomine hydrochloridedicyclomine hydrochloride SOLUTION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0179-0173(NDC:0603-1161)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DICYCLOMINE HYDROCHLORIDE(UNII: CQ903KQA31) (DICYCLOMINE - UNII:4KV4X8IF6V)	DICYCLOMINE HYDROCHLORIDE	10 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SORBITOL(UNII: 506T60A25R)
SUCROSE(UNII: C151H8M554)
WATER(UNII: 059QF0KO0R)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	FRUIT PUNCH	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0179-0173-80	10 mL in 1 CUP, UNIT-DOSE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040169	04/02/2015

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL