metformin hydrochloride

Generic: metformin hydrochloride

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

metformin hydrochloride 500 mg/1

Manufacturer
direct rx

Identifiers & Regulatory

Product NDC 72189-219
Product ID 72189-219_4c4c00bb-696d-96d9-e063-6394a90aba0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203769
Listing Expiration 2027-12-31
Marketing Start 2021-05-26

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189219
Hyphenated Format 72189-219

Supplemental Identifiers

RxCUI
861004 861007 861010
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 ANDA203769 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-219-30)
  • 60 TABLET in 1 BOTTLE (72189-219-60)
  • 180 TABLET in 1 BOTTLE (72189-219-82)
  • 90 TABLET in 1 BOTTLE (72189-219-90)
source: ndc

Packages (4)

72189-219-30 30 TABLET in 1 BOTTLE (72189-219-30) 72189-219-60 60 TABLET in 1 BOTTLE (72189-219-60) 72189-219-82 180 TABLET in 1 BOTTLE (72189-219-82) 72189-219-90 90 TABLET in 1 BOTTLE (72189-219-90)

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": "4c4c00bb-696d-96d9-e063-6394a90aba0e", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["c33e24e9-0441-6b94-e053-2a95a90a9c68"], "manufacturer_name": ["direct rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-219-30)", "package_ndc": "72189-219-30", "marketing_start_date": "20210526"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-219-60)", "package_ndc": "72189-219-60", "marketing_start_date": "20210526"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (72189-219-82)", "package_ndc": "72189-219-82", "marketing_start_date": "20210526"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-219-90)", "package_ndc": "72189-219-90", "marketing_start_date": "20210526"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "72189-219_4c4c00bb-696d-96d9-e063-6394a90aba0e", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "72189-219", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "direct rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA203769", "marketing_category": "ANDA", "marketing_start_date": "20210526", "listing_expiration_date": "20271231"}