NDC Code(s) : 60429-155-01, 60429-155-10, 60429-156-01, 60429-156-10
Packager : Golden State Medical Supply, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DicyclomineDicyclomine Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-155(NDC:0143-3126)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE(UNII: CQ903KQA31)
(DICYCLOMINE - UNII:4KV4X8IF6V) 		DICYCLOMINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (Dark) Score no score
Shape CAPSULE Size 15 mm
Flavor Imprint Code Westward;3126
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-155-01100 in 1 BOTTLE, PLASTIC
2NDC:60429-155-101000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040161 10/01/1996
DicyclomineDicyclomine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-156(NDC:0143-1227)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE(UNII: CQ903KQA31)
(DICYCLOMINE - UNII:4KV4X8IF6V) 		DICYCLOMINE HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (BLUE) Score no score
Shape ROUND (ROUND, embossed) Size 7 mm
Flavor Imprint Code WW;27
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-156-01100 in 1 BOTTLE, PLASTIC
2NDC:60429-156-101000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040161 10/01/1996

PRINCIPAL DISPLAY PANEL

Dicyclomine Hydrochloride Tablets, USP 20 mg/100 Tablets

Label Graphic - 20mg Tablets

PRINCIPAL DISPLAY PANEL

Dicyclomine Hydrochloride Capsules, USP 10 mg/100 Capsules

Label Graphic - Capsules 10 mg