metformin hydrochloride

Generic: metformin hydrochloride

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-1419
Product ID 68071-1419_3f67ac3d-1505-3418-e063-6394a90a938f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201991
Listing Expiration 2026-12-31
Marketing Start 2013-03-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680711419
Hyphenated Format 68071-1419

Supplemental Identifiers

RxCUI
1807917
UPC
0368071141986
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 hydrochloride (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA201991 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-2)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-3)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-6)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-8)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-9)
source: ndc

Packages (5)

68071-1419-2 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-2) 68071-1419-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-3) 68071-1419-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-6) 68071-1419-8 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-8) 68071-1419-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-9)

Ingredients (1)

metformin hydrochloride (500 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": "3f67ac3d-1505-3418-e063-6394a90a938f", "openfda": {"upc": ["0368071141986"], "unii": ["786Z46389E"], "rxcui": ["1807917"], "spl_set_id": ["4be72741-4f6d-6689-e054-00144ff8d46c"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-2)", "package_ndc": "68071-1419-2", "marketing_start_date": "20170329"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-3)", "package_ndc": "68071-1419-3", "marketing_start_date": "20170329"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-6)", "package_ndc": "68071-1419-6", "marketing_start_date": "20170329"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-8)", "package_ndc": "68071-1419-8", "marketing_start_date": "20170329"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-9)", "package_ndc": "68071-1419-9", "marketing_start_date": "20170329"}], "brand_name": "Metformin hydrochloride", "product_id": "68071-1419_3f67ac3d-1505-3418-e063-6394a90a938f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68071-1419", "generic_name": "Metformin hydrochloride", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA201991", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20261231"}