metformin hydrochloride

Generic: metformin hydrochloride

Labeler: aci healthcare usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler aci healthcare usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
ACI Healthcare USA, Inc.

Identifiers & Regulatory

Product NDC 71093-133
Product ID 71093-133_39bb2259-ba80-4602-b468-a2e0d61f48f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203769
Listing Expiration 2026-12-31
Marketing Start 2018-01-15

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71093133
Hyphenated Format 71093-133

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0371093133044 0371093134041 0371093132047
UNII
786Z46389E

Packaging Origin

Original Packager
true

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
  • 850 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (71093-133-04)
  • 500 TABLET in 1 BOTTLE, PLASTIC (71093-133-05)
source: ndc

Packages (2)

71093-133-04 100 TABLET in 1 BOTTLE, PLASTIC (71093-133-04) 71093-133-05 500 TABLET in 1 BOTTLE, PLASTIC (71093-133-05)

Ingredients (1)

metformin hydrochloride (850 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": "39bb2259-ba80-4602-b468-a2e0d61f48f6", "openfda": {"upc": ["0371093133044", "0371093134041", "0371093132047"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["e18b60f9-721e-4db6-9f61-d3437e18faf2"], "manufacturer_name": ["ACI Healthcare USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (71093-133-04)", "package_ndc": "71093-133-04", "marketing_start_date": "20180115"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (71093-133-05)", "package_ndc": "71093-133-05", "marketing_start_date": "20180115"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "71093-133_39bb2259-ba80-4602-b468-a2e0d61f48f6", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71093-133", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "ACI Healthcare USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "850 mg/1"}], "application_number": "ANDA203769", "marketing_category": "ANDA", "marketing_start_date": "20180115", "listing_expiration_date": "20261231"}