NDC Code(s) : 68382-528-42, 68382-528-60
Packager : Zydus Pharmaceuticals (USA) Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CHOLESTYRAMINECHOLESTYRAMINE POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-528
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLESTYRAMINE(UNII: 4B33BGI082)
(CHOLESTYRAMINE - UNII:4B33BGI082) 		CHOLESTYRAMINE4 g in 9 g
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ORANGE(UNII: 5EVU04N5QU)
SUCROSE(UNII: C151H8M554)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
XANTHAN GUM(UNII: TTV12P4NEE)
PROPYLENE GLYCOL ALGINATE(UNII: 26CD3J2R0C)
VANILLA(UNII: Q74T35078H)
Product Characteristics
Color Score
Shape Size
Flavor ORANGE, VANILLA Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-528-42378 g in 1 CAN Type 0: Not a Combination Product08/01/2018
2NDC:68382-528-6060 in 1 CARTON 08/01/2018
29 g in 1 POUCH Type 0: Not a Combination Product08/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202901 08/01/2018

LABELER - Zydus Pharmaceuticals (USA) Inc.(156861945)

REGISTRANT - Zydus Pharmaceuticals (USA) Inc.(156861945)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 677605858 ANALYSIS(68382-528), MANUFACTURE(68382-528)

PRINCIPAL DISPLAY PANEL

NDC 68382-528-42

Cholestyramine for Oral Suspension USP Powder, 4 gm

Rx only

378 gm

ZYDUS

Label

NDC 68382-528-60

Cholestyramine for Oral Suspension USP Powder, 4 gm

Rx only

60 pouch

ZYDUS

Label