metformin hydrochloride

Generic: metformin hydrochloride

Labeler: sciegen pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler sciegen pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
ScieGen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 50228-107
Product ID 50228-107_f1d709ff-59a3-841a-e053-2a95a90a9c29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203769
Listing Expiration 2026-12-31
Marketing Start 2015-02-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228107
Hyphenated Format 50228-107

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0350228105019 0350228107600
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
  • 1000 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50228-107-00)
  • 100 TABLET in 1 BOTTLE (50228-107-01)
  • 500 TABLET in 1 BOTTLE (50228-107-05)
  • 1000 TABLET in 1 BOTTLE (50228-107-10)
  • 30 TABLET in 1 BOTTLE (50228-107-30)
  • 60 TABLET in 1 BOTTLE (50228-107-60)
source: ndc

Packages (6)

50228-107-00 100 TABLET in 1 BOTTLE (50228-107-00) 50228-107-01 100 TABLET in 1 BOTTLE (50228-107-01) 50228-107-05 500 TABLET in 1 BOTTLE (50228-107-05) 50228-107-10 1000 TABLET in 1 BOTTLE (50228-107-10) 50228-107-30 30 TABLET in 1 BOTTLE (50228-107-30) 50228-107-60 60 TABLET in 1 BOTTLE (50228-107-60)

Ingredients (1)

metformin hydrochloride (1000 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": "f1d709ff-59a3-841a-e053-2a95a90a9c29", "openfda": {"upc": ["0350228105019", "0350228107600"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["4e4c4ba9-65c6-4273-8f6b-2423ab521dad"], "manufacturer_name": ["ScieGen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50228-107-00)", "package_ndc": "50228-107-00", "marketing_start_date": "20150201"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (50228-107-01)", "package_ndc": "50228-107-01", "marketing_start_date": "20150201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (50228-107-05)", "package_ndc": "50228-107-05", "marketing_start_date": "20150201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (50228-107-10)", "package_ndc": "50228-107-10", "marketing_start_date": "20150201"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-107-30)", "package_ndc": "50228-107-30", "marketing_start_date": "20150201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (50228-107-60)", "package_ndc": "50228-107-60", "marketing_start_date": "20221226"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "50228-107_f1d709ff-59a3-841a-e053-2a95a90a9c29", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "50228-107", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "ScieGen Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA203769", "marketing_category": "ANDA", "marketing_start_date": "20150201", "listing_expiration_date": "20261231"}