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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 750 mg/1

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-804
Product ID 68094-804_c51354d1-4a04-46cf-b26b-fa94c122d817
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078321
Listing Expiration 2027-12-31
Marketing Start 2024-02-15

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094804
Hyphenated Format 68094-804

Supplemental Identifiers

RxCUI
860975 860981
UPC
0368094904506 0368094804509
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 ANDA078321 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68094-804-50)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68094-804-60)
source: ndc

Packages (2)

68094-804-50 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68094-804-50) 68094-804-60 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68094-804-60)

Ingredients (1)

metformin hydrochloride (750 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": "c51354d1-4a04-46cf-b26b-fa94c122d817", "openfda": {"upc": ["0368094904506", "0368094804509"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["60142fb2-16da-4f54-a542-74f9a70b9c8b"], "manufacturer_name": ["Precision Dose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68094-804-50)", "package_ndc": "68094-804-50", "marketing_start_date": "20240215"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68094-804-60)", "package_ndc": "68094-804-60", "marketing_start_date": "20240215"}], "brand_name": "Metformin Hydrochloride", "product_id": "68094-804_c51354d1-4a04-46cf-b26b-fa94c122d817", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68094-804", "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": "750 mg/1"}], "application_number": "ANDA078321", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20271231"}