sevelamer carbonate

Generic: sevelamer carbonate

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer carbonate
Generic Name sevelamer carbonate
Labeler amneal pharmaceuticals of new york llc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

sevelamer carbonate 800 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1365
Product ID 0115-1365_b673720f-b62b-4afc-ac25-cb2ac4cf326f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211316
Listing Expiration 2026-12-31
Marketing Start 2020-11-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151365
Hyphenated Format 0115-1365

Supplemental Identifiers

RxCUI
861370 861375
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 ANDA211316 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 90 PACKET in 1 CARTON (0115-1365-29) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0115-1365-30)
source: ndc

Packages (1)

0115-1365-29 90 PACKET in 1 CARTON (0115-1365-29) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0115-1365-30)

Ingredients (1)

sevelamer carbonate (800 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": "b673720f-b62b-4afc-ac25-cb2ac4cf326f", "openfda": {"unii": ["9YCX42I8IU"], "rxcui": ["861370", "861375"], "spl_set_id": ["da5239fe-060b-4469-95ac-173adec43b9c"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 PACKET in 1 CARTON (0115-1365-29)  / 1 POWDER, FOR SUSPENSION in 1 PACKET (0115-1365-30)", "package_ndc": "0115-1365-29", "marketing_start_date": "20201120"}], "brand_name": "sevelamer carbonate", "product_id": "0115-1365_b673720f-b62b-4afc-ac25-cb2ac4cf326f", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0115-1365", "generic_name": "sevelamer carbonate", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sevelamer carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA211316", "marketing_category": "ANDA", "marketing_start_date": "20201120", "listing_expiration_date": "20261231"}