metformin hydrochloride

Generic: metformin hydrochloride

Labeler: marksans pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler marksans pharma limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-101
Product ID 25000-101_d303d298-6012-49a4-aff0-ff0f0aeadb1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090295
Listing Expiration 2026-12-31
Marketing Start 2016-05-12

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25000101
Hyphenated Format 25000-101

Supplemental Identifiers

RxCUI
860975 860981
UPC
0325000101039 0325000101121 0325000102128 0325000102036 0325000101145
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 ANDA090295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-03)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-12)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-14)
  • 4 BAG in 1 BOX (25000-101-97) / 2000 TABLET, EXTENDED RELEASE in 1 BAG
  • 1 BAG in 1 BOX (25000-101-98) / 11695 TABLET, EXTENDED RELEASE in 1 BAG
source: ndc

Packages (5)

25000-101-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-03) 25000-101-12 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-12) 25000-101-14 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-14) 25000-101-97 4 BAG in 1 BOX (25000-101-97) / 2000 TABLET, EXTENDED RELEASE in 1 BAG 25000-101-98 1 BAG in 1 BOX (25000-101-98) / 11695 TABLET, EXTENDED RELEASE in 1 BAG

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": "d303d298-6012-49a4-aff0-ff0f0aeadb1b", "openfda": {"upc": ["0325000101039", "0325000101121", "0325000102128", "0325000102036", "0325000101145"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-03)", "package_ndc": "25000-101-03", "marketing_start_date": "20160512"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-12)", "package_ndc": "25000-101-12", "marketing_start_date": "20160512"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-14)", "package_ndc": "25000-101-14", "marketing_start_date": "20220624"}, {"sample": false, "description": "4 BAG in 1 BOX (25000-101-97)  / 2000 TABLET, EXTENDED RELEASE in 1 BAG", "package_ndc": "25000-101-97", "marketing_start_date": "20160512"}, {"sample": false, "description": "1 BAG in 1 BOX (25000-101-98)  / 11695 TABLET, EXTENDED RELEASE in 1 BAG", "package_ndc": "25000-101-98", "marketing_start_date": "20160512"}], "brand_name": "Metformin Hydrochloride", "product_id": "25000-101_d303d298-6012-49a4-aff0-ff0f0aeadb1b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "25000-101", "generic_name": "Metformin Hydrochloride", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090295", "marketing_category": "ANDA", "marketing_start_date": "20160512", "listing_expiration_date": "20261231"}