sevelamer hydrochloride

Generic: sevelamer hydrochloride

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

Drug Facts

Product Profile

Brand Name sevelamer hydrochloride
Generic Name sevelamer hydrochloride
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED
Routes
PARENTERAL
Active Ingredients

sevelamer hydrochloride 800 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-447
Product ID 68462-447_5b27539f-4664-4a6b-abe4-2abcc7ad2279
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204724
Listing Expiration 2027-12-31
Marketing Start 2019-02-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462447
Hyphenated Format 68462-447

Supplemental Identifiers

RxCUI
857216 857224
UPC
0368462447185 0368462446263
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 ANDA204724 (source: ndc)
Routes
PARENTERAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (68462-447-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68462-447-30)
source: ndc

Packages (2)

68462-447-18 180 TABLET, FILM COATED in 1 BOTTLE (68462-447-18) 68462-447-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-447-30)

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": ["PARENTERAL"], "spl_id": "5b27539f-4664-4a6b-abe4-2abcc7ad2279", "openfda": {"upc": ["0368462447185", "0368462446263"], "unii": ["GLS2PGI8QG"], "rxcui": ["857216", "857224"], "spl_set_id": ["2cd6512f-0edd-4a30-a4fa-aa996038633c"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (68462-447-18)", "package_ndc": "68462-447-18", "marketing_start_date": "20190208"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68462-447-30)", "package_ndc": "68462-447-30", "marketing_start_date": "20190208"}], "brand_name": "sevelamer hydrochloride", "product_id": "68462-447_5b27539f-4664-4a6b-abe4-2abcc7ad2279", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "68462-447", "generic_name": "sevelamer hydrochloride", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sevelamer hydrochloride", "active_ingredients": [{"name": "SEVELAMER HYDROCHLORIDE", "strength": "800 mg/1"}], "application_number": "ANDA204724", "marketing_category": "ANDA", "marketing_start_date": "20190208", "listing_expiration_date": "20271231"}