NDC Code(s) : 70677-0060-1
Packager : STRATEGIC SOURCING SERVICES, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Anti-DiarrhealLOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0060
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE(UNII: 77TI35393C)
(LOPERAMIDE - UNII:6X9OC3H4II) 		LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 10 mm
Flavor Imprint Code P13
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70677-0060-12 in 1 CARTON 15/12/2018
112 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021855 12/15/2018 10/31/2025

LABELER - STRATEGIC SOURCING SERVICES, LLC(116956644)

REGISTRANT - Bionpharma Inc.(079637826)

Establishment
Name Address ID/FEI Business Operations
Patheon Softgels Inc. 002193829 manufacture(70677-0060)

PRINCIPAL DISPLAY PANEL

sunmark TM

COMPARE TO IMODIUM ® A-D

ACTIVE INGREDIENT†

NDC 70677-0060-1
anti-diarrheal

Loperamide HCl Soft Gelatin Capsules, 2 mg

Suitable for adults and children

12 years and over

Controls the symptoms of diarrhea

24 SOFTGELS*

*each liquid-filled capsule contains 2 mg loperamide HCl

24