metformin hydrochloride

Generic: metformin hydrochloride

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler ajanta pharma usa inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-240
Product ID 27241-240_ea6802dc-fb15-47c2-bcff-d7b920ba7986
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213962
Listing Expiration 2027-12-31
Marketing Start 2021-03-09

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241240
Hyphenated Format 27241-240

Supplemental Identifiers

RxCUI
1807888 1807915
UPC
0327241241901 0327241240010
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 ANDA213962 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-240-01)
source: ndc

Packages (1)

27241-240-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-240-01)

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": "ea6802dc-fb15-47c2-bcff-d7b920ba7986", "openfda": {"upc": ["0327241241901", "0327241240010"], "unii": ["786Z46389E"], "rxcui": ["1807888", "1807915"], "spl_set_id": ["1ed9dde4-339c-486f-a346-dde33a5e493f"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-240-01)", "package_ndc": "27241-240-01", "marketing_start_date": "20210309"}], "brand_name": "Metformin hydrochloride", "product_id": "27241-240_ea6802dc-fb15-47c2-bcff-d7b920ba7986", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "27241-240", "generic_name": "Metformin hydrochloride", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA213962", "marketing_category": "ANDA", "marketing_start_date": "20210309", "listing_expiration_date": "20271231"}