sevelamer carbonate

Generic: sevelamer carbonate

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer carbonate
Generic Name sevelamer carbonate
Labeler bionpharma inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

sevelamer carbonate 2400 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-127
Product ID 69452-127_204ad91c-58e0-5be6-e063-6294a90a5574
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209374
Listing Expiration 2026-12-31
Marketing Start 2021-09-01

Pharmacologic Class

Classes
phosphate binder [epc] phosphate chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452127
Hyphenated Format 69452-127

Supplemental Identifiers

RxCUI
861370 861375
UPC
0369452126608 0369452127605
UNII
9YCX42I8IU

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sevelamer carbonate (source: ndc)
Generic Name sevelamer carbonate (source: ndc)
Application Number ANDA209374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2400 mg/1
source: ndc
Packaging
  • 90 PACKET in 1 CARTON (69452-127-19) / 1 POWDER, FOR SUSPENSION in 1 PACKET (69452-127-60)
source: ndc

Packages (1)

69452-127-19 90 PACKET in 1 CARTON (69452-127-19) / 1 POWDER, FOR SUSPENSION in 1 PACKET (69452-127-60)

Ingredients (1)

sevelamer carbonate (2400 mg/1)

Linked Drug Pages (1)

Sevelamer Carbonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "204ad91c-58e0-5be6-e063-6294a90a5574", "openfda": {"upc": ["0369452126608", "0369452127605"], "unii": ["9YCX42I8IU"], "rxcui": ["861370", "861375"], "spl_set_id": ["c3cf4807-ae5f-528e-e053-2a95a90ac640"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 PACKET in 1 CARTON (69452-127-19)  / 1 POWDER, FOR SUSPENSION in 1 PACKET (69452-127-60)", "package_ndc": "69452-127-19", "marketing_start_date": "20211001"}], "brand_name": "Sevelamer Carbonate", "product_id": "69452-127_204ad91c-58e0-5be6-e063-6294a90a5574", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "69452-127", "generic_name": "Sevelamer Carbonate", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "2400 mg/1"}], "application_number": "ANDA209374", "marketing_category": "ANDA", "marketing_start_date": "20210901", "listing_expiration_date": "20261231"}