metformin hydrochloride

Generic: metformin hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-622
Product ID 71205-622_003ffb4b-1018-4cf7-af05-0eba0097f9d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2019-06-26

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205622
Hyphenated Format 71205-622

Supplemental Identifiers

RxCUI
861007
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 ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71205-622-30)
  • 60 TABLET in 1 BOTTLE (71205-622-60)
  • 90 TABLET in 1 BOTTLE (71205-622-90)
source: ndc

Packages (3)

71205-622-30 30 TABLET in 1 BOTTLE (71205-622-30) 71205-622-60 60 TABLET in 1 BOTTLE (71205-622-60) 71205-622-90 90 TABLET in 1 BOTTLE (71205-622-90)

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": "003ffb4b-1018-4cf7-af05-0eba0097f9d8", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861007"], "spl_set_id": ["d51f3618-4166-4925-8994-968a653ebc46"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-622-30)", "package_ndc": "71205-622-30", "marketing_start_date": "20211117"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-622-60)", "package_ndc": "71205-622-60", "marketing_start_date": "20211117"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-622-90)", "package_ndc": "71205-622-90", "marketing_start_date": "20211117"}], "brand_name": "Metformin Hydrochloride", "product_id": "71205-622_003ffb4b-1018-4cf7-af05-0eba0097f9d8", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71205-622", "generic_name": "Metformin Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20190626", "listing_expiration_date": "20261231"}