NDC Code(s) : 70954-261-10
Packager : Novitium Pharma LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dicyclomine Hydrochloride Dicyclomine Hydrochloride SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:70954-261
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 in 5 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SORBITOL(UNII: 506T60A25R)
SUCROSE(UNII: C151H8M554)
SACCHARIN SODIUM MONOHYDRATE(UNII: A9CO00M9HV)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color PINK (Light pink) Score
Shape Size
Flavor FRUIT PUNCH Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70954-261-10473 mL in 1 BOTTLE Type 0: Not a Combination Product23/04/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214721 04/23/2021

LABELER - Novitium Pharma LLC(080301870)

Establishment
Name Address ID/FEI Business Operations
Novitium Pharma LLC 080301870 MANUFACTURE(70954-261), PACK(70954-261)

PRINCIPAL DISPLAY PANEL

Dicyclomine Hydrochloride Oral Solution, USP 10 mg/5 mL

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