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 42291-497
Product ID 42291-497_485f88a3-e04d-a929-e063-6394a90a524d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078596
Listing Expiration 2027-12-31
Marketing Start 2022-03-31

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291497
Hyphenated Format 42291-497

Supplemental Identifiers

RxCUI
860975 860981
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 ANDA078596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-01)
  • 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-05)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-12)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-18)
  • 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-36)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-50)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-90)
source: ndc

Packages (7)

42291-497-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-01) 42291-497-05 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-05) 42291-497-12 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-12) 42291-497-18 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-18) 42291-497-36 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-36) 42291-497-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-50) 42291-497-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-90)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (2)

Metformin Hydrochloride ndc-match (0.9) Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "485f88a3-e04d-a929-e063-6394a90a524d", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["db893bbe-95af-bbec-e053-2a95a90ae0e9"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-01)", "package_ndc": "42291-497-01", "marketing_start_date": "20220331"}, {"sample": false, "description": "50 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-05)", "package_ndc": "42291-497-05", "marketing_start_date": "20230425"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-12)", "package_ndc": "42291-497-12", "marketing_start_date": "20230425"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-18)", "package_ndc": "42291-497-18", "marketing_start_date": "20220331"}, {"sample": false, "description": "360 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-36)", "package_ndc": "42291-497-36", "marketing_start_date": "20220331"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-50)", "package_ndc": "42291-497-50", "marketing_start_date": "20230425"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-90)", "package_ndc": "42291-497-90", "marketing_start_date": "20220331"}], "brand_name": "Metformin Hydrochloride", "product_id": "42291-497_485f88a3-e04d-a929-e063-6394a90a524d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "42291-497", "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": "ANDA078596", "marketing_category": "ANDA", "marketing_start_date": "20220331", "listing_expiration_date": "20271231"}