NDC Code(s) : 68788-8525-2, 68788-8525-3, 68788-8525-6, 68788-8525-1
Packager : Preferred Pharmaceuticals 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:68788-8525(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, UNSPECIFIED FORM(UNII: WAT0DDB505)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN, UNSPECIFIED(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:68788-8525-220 in 1 BOTTLE Type 0: Not a Combination Product14/09/2023
2NDC:68788-8525-330 in 1 BOTTLE Type 0: Not a Combination Product14/09/2023
3NDC:68788-8525-660 in 1 BOTTLE Type 0: Not a Combination Product14/09/2023
4NDC:68788-8525-1100 in 1 BOTTLE Type 0: Not a Combination Product14/09/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217054 09/14/2023

LABELER - Preferred Pharmaceuticals Inc.(791119022)

REGISTRANT - Preferred Pharmaceuticals Inc.(791119022)

Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-8525)

PRINCIPAL DISPLAY PANEL

NDC 68788-8525

Dicyclomine Hydrochloride Capsules, USP

10 mg

Rx Only

TWi

Dicyclomine Hydrochloride Capsules USP10mg