NDC Code(s) : 69097-967-93
Packager : Cipla USA 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:69097-967
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
DIACETYLATED MONOGLYCERIDES(UNII: 5Z17386USF)
Product Characteristics
Color WHITE (WHITE) Score no score
Shape CAPSULE (modified capsule shaped, biconvex) Size 21 mm
Flavor Imprint Code I;8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-967-93270 in 1 BOTTLE Type 0: Not a Combination Product08/08/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203860 10/26/2017

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
InvaGen Pharmaceuticals Inc. 165104469 MANUFACTURE(69097-967), ANALYSIS(69097-967)

Establishment
Name Address ID/FEI Business Operations
Cipla limited 917066446 manufacture(69097-967), analysis(69097-967), pack(69097-967)

Establishment
Name Address ID/FEI Business Operations
InvaGen Pharmaceuticals Inc. 080334903 analysis(69097-967), pack(69097-967)

PRINCIPAL DISPLAY PANEL

NDC 69097-967-93                 Rx Only

Sevelamer
Carbonate
Tablets

800 mg

270 film coated tablets

Cipla

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