NDC Code(s) : 68382-529-42, 68382-529-60
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:68382-529
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 5.5 g
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
ASPARTAME(UNII: Z0H242BBR1)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
MANNITOL(UNII: 3OWL53L36A)
ORANGE(UNII: 5EVU04N5QU)
PROPYLENE GLYCOL ALGINATE(UNII: 26CD3J2R0C)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
VANILLA(UNII: Q74T35078H)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color YELLOW (whitish yellow) Score
Shape Size
Flavor VANILLA, ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-529-42231 g in 1 CONTAINER Type 0: Not a Combination Product06/08/2017
2NDC:68382-529-6060 in 1 CARTON 06/08/2017
25.5 g in 1 POUCH Type 0: Not a Combination Product06/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202902 06/08/2017

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

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

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 677605858 ANALYSIS(68382-529), MANUFACTURE(68382-529)

PRINCIPAL DISPLAY PANEL

NDC 68382-529-42

Cholestyramine for Oral Suspension USP Light Powder, 4 gm

Rx only

231 gm

ZYDUS

Label

NDC 68382-529-60

Cholestyramine for Oral Suspension USP Light Powder, 4 gm

Rx only

60 Pouch

ZYDUS

Label