NDC Code(s) : 68071-3522-3
Packager : NuCare Pharmaceutials,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dicyclomine HydrochlorideDicyclomine Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3522(NDC:24979-201)
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CALCIUM SULFATE(UNII: WAT0DDB505)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code TWi;T201
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68071-3522-330 in 1 BOTTLE Type 0: Not a Combination Product17/10/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217054 02/01/2023

LABELER - NuCare Pharmaceutials,Inc.(010632300)

Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 repack(68071-3522)

PRINCIPAL DISPLAY PANEL

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