sevelamer hydrochloride

Generic: sevelamer hydrochloride

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer hydrochloride
Generic Name sevelamer hydrochloride
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sevelamer hydrochloride 800 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-173
Product ID 70748-173_cc130cfa-f3e5-460d-92a8-69cc0f958dd2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213145
Listing Expiration 2026-12-31
Marketing Start 2022-02-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70748173
Hyphenated Format 70748-173

Supplemental Identifiers

RxCUI
857224
UNII
GLS2PGI8QG

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 hydrochloride (source: ndc)
Generic Name sevelamer hydrochloride (source: ndc)
Application Number ANDA213145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 180 TABLET in 1 BOTTLE (70748-173-26)
source: ndc

Packages (1)

70748-173-26 180 TABLET in 1 BOTTLE (70748-173-26)

Ingredients (1)

sevelamer hydrochloride (800 mg/1)

Linked Drug Pages (1)

Sevelamer hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cc130cfa-f3e5-460d-92a8-69cc0f958dd2", "openfda": {"unii": ["GLS2PGI8QG"], "rxcui": ["857224"], "spl_set_id": ["a56c857e-bc39-484c-908d-f5957857efbb"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE (70748-173-26)", "package_ndc": "70748-173-26", "marketing_start_date": "20220225"}], "brand_name": "Sevelamer hydrochloride", "product_id": "70748-173_cc130cfa-f3e5-460d-92a8-69cc0f958dd2", "dosage_form": "TABLET", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "70748-173", "generic_name": "Sevelamer hydrochloride", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer hydrochloride", "active_ingredients": [{"name": "SEVELAMER HYDROCHLORIDE", "strength": "800 mg/1"}], "application_number": "ANDA213145", "marketing_category": "ANDA", "marketing_start_date": "20220225", "listing_expiration_date": "20261231"}