NDC Code(s) : 51407-821-12
Packager : Golden State Medical Supply, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dicyclomine HydrochlorideDicyclomine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-821(NDC:24979-200)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Product Characteristics
Color blue Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code T;200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51407-821-12120 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product19/07/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216782 06/01/2023

LABELER - Golden State Medical Supply, Inc.(603184490)

Establishment
Name Address ID/FEI Business Operations
Golden State Medical Supply, Inc. 603184490 relabel(51407-821), repack(51407-821)

PRINCIPAL DISPLAY PANEL

NDC 51407-821-12

Dicyclomine Hydrochloride Tablets, USP

20 mg

Rx only

120 Tablets

Dicyclomine Hydrochloride Tablets - 51407-821-12LB - TWI - Rev. 0923.jpg