NDC Code(s) : 68462-446-30, 68462-446-26, 68462-447-30, 68462-447-18
Packager : Glenmark Pharmaceuticals Inc., USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

sevelamer hydrochloridesevelamer hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-446
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVELAMER HYDROCHLORIDE(UNII: GLS2PGI8QG)
(SEVELAMER - UNII:941N5DUU5C) 		SEVELAMER HYDROCHLORIDE400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
ZINC STEARATE(UNII: H92E6QA4FV)
DIACETYLATED MONOGLYCERIDES(UNII: 5Z17386USF)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MANNITOL(UNII: 3OWL53L36A)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
STARCH, CORN(UNII: O8232NY3SJ)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color WHITE (off-white to pale yellow) Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code G446
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-446-3030 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
2NDC:68462-446-26360 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204724 02/08/2019
sevelamer hydrochloridesevelamer hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-447
Route of Administration PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVELAMER HYDROCHLORIDE(UNII: GLS2PGI8QG)
(SEVELAMER - UNII:941N5DUU5C) 		SEVELAMER HYDROCHLORIDE800 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
ZINC STEARATE(UNII: H92E6QA4FV)
DIACETYLATED MONOGLYCERIDES(UNII: 5Z17386USF)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MANNITOL(UNII: 3OWL53L36A)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
STARCH, CORN(UNII: O8232NY3SJ)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color WHITE (off-white to pale yellow) Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code G447
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-447-3030 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
2NDC:68462-447-18180 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204724 02/08/2019

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 862603186 ANALYSIS(68462-446, 68462-447), MANUFACTURE(68462-446, 68462-447)

PRINCIPAL DISPLAY PANEL

NDC 68462-446-26

Sevelamer Hydrochloride Tablets

400 mg

Bottle Label

bottle-label-400-mg

PRINCIPAL DISPLAY PANEL

NDC 68462-447-18

Sevelamer Hydrochloride Tablets

800 mg

Bottle Label

bottle-label-800-mg