metformin hydrochloride

Generic: metformin hydrochloride

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-521
Product ID 68462-521_75378e1b-a55d-48ee-9a0a-cd82d2fb78a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212969
Listing Expiration 2027-12-31
Marketing Start 2019-11-25

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462521
Hyphenated Format 68462-521

Supplemental Identifiers

RxCUI
1807888 1807915
UPC
0368462521908 0368462520017
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 ANDA212969 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-05)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-90)
source: ndc

Packages (3)

68462-521-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-01) 68462-521-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-05) 68462-521-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-90)

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": "75378e1b-a55d-48ee-9a0a-cd82d2fb78a0", "openfda": {"upc": ["0368462521908", "0368462520017"], "unii": ["786Z46389E"], "rxcui": ["1807888", "1807915"], "spl_set_id": ["0ef9de1a-b786-4b6c-a250-3f5ac532b16a"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-01)", "package_ndc": "68462-521-01", "marketing_start_date": "20191125"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-05)", "package_ndc": "68462-521-05", "marketing_start_date": "20191125"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-90)", "package_ndc": "68462-521-90", "marketing_start_date": "20191125"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "68462-521_75378e1b-a55d-48ee-9a0a-cd82d2fb78a0", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68462-521", "generic_name": "metformin hydrochloride", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA212969", "marketing_category": "ANDA", "marketing_start_date": "20191125", "listing_expiration_date": "20271231"}