metformin hcl

Generic: metformin hcl

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hcl
Generic Name metformin hcl
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-635
Product ID 72189-635_3ac4e864-4b8b-13b1-e063-6294a90ada66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213320
Listing Expiration 2026-12-31
Marketing Start 2025-07-25

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189635
Hyphenated Format 72189-635

Supplemental Identifiers

RxCUI
861004
UNII
786Z46389E

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 metformin hcl (source: ndc)
Generic Name metformin hcl (source: ndc)
Application Number ANDA213320 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 180 TABLET in 1 BOTTLE (72189-635-82)
source: ndc

Packages (1)

72189-635-82 180 TABLET in 1 BOTTLE (72189-635-82)

Ingredients (1)

metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

Metformin HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ac4e864-4b8b-13b1-e063-6294a90ada66", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004"], "spl_set_id": ["3ac4e864-4b8a-13b1-e063-6294a90ada66"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE (72189-635-82)", "package_ndc": "72189-635-82", "marketing_start_date": "20250725"}], "brand_name": "Metformin HCL", "product_id": "72189-635_3ac4e864-4b8b-13b1-e063-6294a90ada66", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "72189-635", "generic_name": "Metformin HCL", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin HCL", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA213320", "marketing_category": "ANDA", "marketing_start_date": "20250725", "listing_expiration_date": "20261231"}