metformin hydrochloride extended-release 500mg

Generic: metformin hydrochloride

Labeler: calvin scott & co., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride extended-release 500mg
Generic Name metformin hydrochloride
Labeler calvin scott & co., inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Calvin Scott & Co., Inc.

Identifiers & Regulatory

Product NDC 17224-311
Product ID 17224-311_da8083b6-aeff-e1ee-e053-2a95a90a0844
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078321
Listing Expiration 2026-12-31
Marketing Start 2017-06-08

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 17224311
Hyphenated Format 17224-311

Supplemental Identifiers

RxCUI
860975
UNII
786Z46389E

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 extended-release 500mg (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA078321 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-311-28)
source: ndc

Packages (1)

17224-311-28 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-311-28)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin Hydrochloride Extended-Release 500mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "da8083b6-aeff-e1ee-e053-2a95a90a0844", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["e9cd0d23-56eb-40dd-abf4-9e681ec220f5"], "manufacturer_name": ["Calvin Scott & Co., Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-311-28)", "package_ndc": "17224-311-28", "marketing_start_date": "20170608"}], "brand_name": "Metformin Hydrochloride Extended-Release 500mg", "product_id": "17224-311_da8083b6-aeff-e1ee-e053-2a95a90a0844", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "17224-311", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Calvin Scott & Co., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride Extended-Release 500mg", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA078321", "marketing_category": "ANDA", "marketing_start_date": "20170608", "listing_expiration_date": "20261231"}