metformin hcl

Generic: metformin hcl

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hcl
Generic Name metformin hcl
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-192
Product ID 72789-192_373a1d26-a38f-a2c2-e063-6394a90a7403
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2017-02-06

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789192
Hyphenated Format 72789-192

Supplemental Identifiers

RxCUI
861007
UPC
0372789192604
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 ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE, PLASTIC (72789-192-20)
  • 21 TABLET in 1 BOTTLE, PLASTIC (72789-192-21)
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-192-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (72789-192-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-192-90)
  • 180 TABLET in 1 BOTTLE, PLASTIC (72789-192-93)
source: ndc

Packages (6)

72789-192-20 20 TABLET in 1 BOTTLE, PLASTIC (72789-192-20) 72789-192-21 21 TABLET in 1 BOTTLE, PLASTIC (72789-192-21) 72789-192-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-192-30) 72789-192-60 60 TABLET in 1 BOTTLE, PLASTIC (72789-192-60) 72789-192-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-192-90) 72789-192-93 180 TABLET in 1 BOTTLE, PLASTIC (72789-192-93)

Ingredients (1)

metformin hydrochloride (500 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": "373a1d26-a38f-a2c2-e063-6394a90a7403", "openfda": {"upc": ["0372789192604"], "unii": ["786Z46389E"], "rxcui": ["861007"], "spl_set_id": ["fb890205-5d43-41eb-97b2-fb0dcdd3a950"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (72789-192-20)", "package_ndc": "72789-192-20", "marketing_start_date": "20211207"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE, PLASTIC (72789-192-21)", "package_ndc": "72789-192-21", "marketing_start_date": "20220830"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-192-30)", "package_ndc": "72789-192-30", "marketing_start_date": "20210806"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (72789-192-60)", "package_ndc": "72789-192-60", "marketing_start_date": "20210817"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-192-90)", "package_ndc": "72789-192-90", "marketing_start_date": "20210614"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (72789-192-93)", "package_ndc": "72789-192-93", "marketing_start_date": "20210615"}], "brand_name": "Metformin HCl", "product_id": "72789-192_373a1d26-a38f-a2c2-e063-6394a90a7403", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "72789-192", "generic_name": "Metformin HCl", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin HCl", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20170206", "listing_expiration_date": "20261231"}