sevelamer carbonate

Generic: sevelamer carbonate

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer carbonate
Generic Name sevelamer carbonate
Labeler strides pharma science limited
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

sevelamer carbonate 800 mg/930mg

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-880
Product ID 64380-880_f0d25733-65a5-4143-a027-3412ff7a167d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211917
Listing Expiration 2026-12-31
Marketing Start 2024-02-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380880
Hyphenated Format 64380-880

Supplemental Identifiers

RxCUI
861370 861375
UPC
0364380880806 0364380881803
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 ANDA211917 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/930mg
source: ndc
Packaging
  • 90 PACKET in 1 CARTON (64380-880-80) / 800 mg in 1 PACKET (64380-880-00)
source: ndc

Packages (1)

64380-880-80 90 PACKET in 1 CARTON (64380-880-80) / 800 mg in 1 PACKET (64380-880-00)

Ingredients (1)

sevelamer carbonate (800 mg/930mg)

Linked Drug Pages (1)

SEVELAMER CARBONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f0d25733-65a5-4143-a027-3412ff7a167d", "openfda": {"upc": ["0364380880806", "0364380881803"], "unii": ["9YCX42I8IU"], "rxcui": ["861370", "861375"], "spl_set_id": ["c17bff97-8347-43f8-822e-1cb9736562b6"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 PACKET in 1 CARTON (64380-880-80)  / 800 mg in 1 PACKET (64380-880-00)", "package_ndc": "64380-880-80", "marketing_start_date": "20240202"}], "brand_name": "SEVELAMER CARBONATE", "product_id": "64380-880_f0d25733-65a5-4143-a027-3412ff7a167d", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "64380-880", "generic_name": "sevelamer carbonate", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SEVELAMER CARBONATE", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/930mg"}], "application_number": "ANDA211917", "marketing_category": "ANDA", "marketing_start_date": "20240202", "listing_expiration_date": "20261231"}