NDC Code(s) : 24979-186-46
Packager : TWi Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sevelamer CarbonateSevelamer Carbonate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-186
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVELAMER CARBONATE(UNII: 9YCX42I8IU)
(SEVELAMER - UNII:941N5DUU5C) 		SEVELAMER CARBONATE800 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ZINC STEARATE(UNII: H92E6QA4FV)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 20 mm
Flavor Imprint Code T186
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-186-46270 in 1 BOTTLE Type 0: Not a Combination Product30/09/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200959 09/30/2019

LABELER - TWi Pharmaceuticals, Inc.(658402052)

Establishment
Name Address ID/FEI Business Operations
TWi Pharmaceuticals, Inc. Zhongli Plant 658863394 manufacture(24979-186), analysis(24979-186)

Establishment
Name Address ID/FEI Business Operations
Bora Pharmaceutical Laboratories Inc. 656139511 manufacture(24979-186), analysis(24979-186), pack(24979-186)

Establishment
Name Address ID/FEI Business Operations
Apace Packaging LLC 361961142 pack(24979-186), label(24979-186)

Establishment
Name Address ID/FEI Business Operations
Formosa Laboratories, Inc 657846858 API MANUFACTURE(24979-186)

PRINCIPAL DISPLAY PANEL

NDC 24979-186-46

Sevelamer Carbonate Tablets
800 mg
Rx only
270 Tablets

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