metformin hydrochloride

Generic: metformin hydrochloride

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler precision dose, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-580
Product ID 68094-580_ef55270e-91c5-46cf-89a5-afec4872afa4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205096
Listing Expiration 2026-12-31
Marketing Start 2024-02-15

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094580
Hyphenated Format 68094-580

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0368094580601 0368094480604
UNII
786Z46389E

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 metformin hydrochloride (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA205096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 500 TABLET, COATED in 1 BOTTLE (68094-580-60)
  • 1000 TABLET, COATED in 1 BOTTLE (68094-580-70)
source: ndc

Packages (2)

68094-580-60 500 TABLET, COATED in 1 BOTTLE (68094-580-60) 68094-580-70 1000 TABLET, COATED in 1 BOTTLE (68094-580-70)

Ingredients (1)

metformin hydrochloride (850 mg/1)

Linked Drug Pages (1)

Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ef55270e-91c5-46cf-89a5-afec4872afa4", "openfda": {"upc": ["0368094580601", "0368094480604"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["37ff1b8e-a434-41c0-82e1-4583842921a5"], "manufacturer_name": ["Precision Dose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (68094-580-60)", "package_ndc": "68094-580-60", "marketing_start_date": "20240215"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (68094-580-70)", "package_ndc": "68094-580-70", "marketing_start_date": "20240215"}], "brand_name": "Metformin Hydrochloride", "product_id": "68094-580_ef55270e-91c5-46cf-89a5-afec4872afa4", "dosage_form": "TABLET, COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68094-580", "generic_name": "Metformin Hydrochloride", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "850 mg/1"}], "application_number": "ANDA205096", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20261231"}