metformin hydrochloride

Generic: metformin hydrochloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler avkare
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-825
Product ID 42291-825_42c9e096-bccc-ad6e-e063-6294a90a4e5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207427
Listing Expiration 2026-12-31
Marketing Start 2024-06-11

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291825
Hyphenated Format 42291-825

Supplemental Identifiers

RxCUI
860975 860981
UPC
0342291824904 0342291825901
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 ANDA207427 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-10)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-12)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-18)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-30)
  • 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-36)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-90)
source: ndc

Packages (7)

42291-825-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-10) 42291-825-12 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-12) 42291-825-18 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-18) 42291-825-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-30) 42291-825-36 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-36) 42291-825-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-60) 42291-825-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-90)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin hydrochloride ER, Metformin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42c9e096-bccc-ad6e-e063-6294a90a4e5e", "openfda": {"upc": ["0342291824904", "0342291825901"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["1aa40000-877f-8ea4-e063-6394a90a0e31"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-10)", "package_ndc": "42291-825-10", "marketing_start_date": "20240611"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-12)", "package_ndc": "42291-825-12", "marketing_start_date": "20240611"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-18)", "package_ndc": "42291-825-18", "marketing_start_date": "20240611"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-30)", "package_ndc": "42291-825-30", "marketing_start_date": "20251103"}, {"sample": false, "description": "360 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-36)", "package_ndc": "42291-825-36", "marketing_start_date": "20240611"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-60)", "package_ndc": "42291-825-60", "marketing_start_date": "20251103"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-90)", "package_ndc": "42291-825-90", "marketing_start_date": "20240611"}], "brand_name": "Metformin hydrochloride", "product_id": "42291-825_42c9e096-bccc-ad6e-e063-6294a90a4e5e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "42291-825", "generic_name": "Metformin hydrochloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA207427", "marketing_category": "ANDA", "marketing_start_date": "20240611", "listing_expiration_date": "20261231"}