sevelamer carbonate

Generic: sevelamer carbonate

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer carbonate
Generic Name sevelamer carbonate
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sevelamer carbonate 800 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-378
Product ID 42571-378_d807f196-f1f8-0a8f-e053-2a95a90aab8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215537
Listing Expiration 2026-12-31
Marketing Start 2022-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571378
Hyphenated Format 42571-378

Supplemental Identifiers

RxCUI
749206
UPC
0342571378301
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 ANDA215537 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (42571-378-30)
  • 270 TABLET in 1 BOTTLE (42571-378-43)
source: ndc

Packages (2)

42571-378-30 30 TABLET in 1 BOTTLE (42571-378-30) 42571-378-43 270 TABLET in 1 BOTTLE (42571-378-43)

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": "d807f196-f1f8-0a8f-e053-2a95a90aab8d", "openfda": {"upc": ["0342571378301"], "unii": ["9YCX42I8IU"], "rxcui": ["749206"], "spl_set_id": ["9977f652-b3e7-43bc-bf3f-1f54698c5f7a"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (42571-378-30)", "package_ndc": "42571-378-30", "marketing_start_date": "20220501"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (42571-378-43)", "package_ndc": "42571-378-43", "marketing_start_date": "20220501"}], "brand_name": "SEVELAMER CARBONATE", "product_id": "42571-378_d807f196-f1f8-0a8f-e053-2a95a90aab8d", "dosage_form": "TABLET", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "42571-378", "generic_name": "SEVELAMER CARBONATE", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SEVELAMER CARBONATE", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA215537", "marketing_category": "ANDA", "marketing_start_date": "20220501", "listing_expiration_date": "20261231"}