Sevelamer Carbonate (Page 5 of 5)

Package Label — Principal Display Panel — 2.4 g Packets, 90 per Carton

NDC 69452-127-19

Sevelamer Carbonate

For Oral Suspension

2.4 g packets

Lemon Flavor

Rx only

Contains 90 packets

2.4 g packets carton
(click image for full-size original)

SEVELAMER CARBONATE
sevelamer carbonate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-126
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVELAMER CARBONATE (SEVELAMER) SEVELAMER CARBONATE 800 mg
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL ALGINATE
SILICON DIOXIDE
SODIUM CHLORIDE
SUCRALOSE
Product Characteristics
Color Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-126-19 90 PACKET in 1 CARTON contains a PACKET (69452-126-60)
1 NDC:69452-126-60 1 POWDER, FOR SUSPENSION in 1 PACKET This package is contained within the CARTON (69452-126-19)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209374 09/01/2021
SEVELAMER CARBONATE
sevelamer carbonate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-127
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVELAMER CARBONATE (SEVELAMER) SEVELAMER CARBONATE 2400 mg
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL ALGINATE
SILICON DIOXIDE
SODIUM CHLORIDE
SUCRALOSE
Product Characteristics
Color Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-127-19 90 PACKET in 1 CARTON contains a PACKET (69452-127-60)
1 NDC:69452-127-60 1 POWDER, FOR SUSPENSION in 1 PACKET This package is contained within the CARTON (69452-127-19)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209374 09/01/2021
Labeler — Bionpharma Inc. (079637826)
Registrant — Bionpharma Inc. (079637826)
Establishment
Name Address ID/FEI Operations
APPCO PHARMA LLC 078510186 manufacture (69452-126), manufacture (69452-127)
Establishment
Name Address ID/FEI Operations
ALPEX PHARMA SA 481608818 manufacture (69452-126), manufacture (69452-127)

Revised: 11/2021 Bionpharma Inc.

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