Welchol

Generic: colesevelam hydrochloride

Labeler: Daiichi Sankyo Inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive

Drug Facts

Product Profile

Brand Name Welchol
Generic Name colesevelam hydrochloride
Labeler Daiichi Sankyo Inc.
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

COLESEVELAM HYDROCHLORIDE 3.75 g/1

Identifiers & Regulatory

Product NDC 65597-902
Product ID 65597-902_3e806127-4a87-41cc-9b17-a77e20bb2452
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022362
Marketing Start 2010-01-01
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65597902
Hyphenated Format 65597-902

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 Welchol (source: ndc)
Generic Name colesevelam hydrochloride (source: ndc)
Application Number NDA022362 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.75 g/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (65597-902-30) / 1 FOR SUSPENSION in 1 PACKET
source: ndc

Packages (1)

65597-902-30 30 PACKET in 1 CARTON (65597-902-30) / 1 FOR SUSPENSION in 1 PACKET

Ingredients (1)

COLESEVELAM HYDROCHLORIDE (3.75 g/1)

Linked Drug Pages (1)

Welchol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e806127-4a87-41cc-9b17-a77e20bb2452", "openfda": {"upc": ["0365597902305"], "unii": ["P4SG24WI5Q"], "rxcui": ["866900", "866903", "866905", "866907", "866910", "866912", "2123384", "2123387"], "spl_set_id": ["4a06d3b2-7229-4398-baba-5d0a72f63821"], "manufacturer_name": ["Daiichi Sankyo Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (65597-902-30)  / 1 FOR SUSPENSION in 1 PACKET", "package_ndc": "65597-902-30", "marketing_end_date": "20260228", "marketing_start_date": "20100101"}], "brand_name": "Welchol", "product_id": "65597-902_3e806127-4a87-41cc-9b17-a77e20bb2452", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "65597-902", "generic_name": "colesevelam hydrochloride", "labeler_name": "Daiichi Sankyo Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Welchol", "active_ingredients": [{"name": "COLESEVELAM HYDROCHLORIDE", "strength": "3.75 g/1"}], "application_number": "NDA022362", "marketing_category": "NDA", "marketing_end_date": "20260228", "marketing_start_date": "20100101"}