metformin hydrochloride

Generic: metformin hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

metformin hydrochloride 500 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-550
Product ID 50268-550_47e74e26-3f97-482a-e063-6394a90a3ac9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078321
Listing Expiration 2027-12-31
Marketing Start 2022-03-08

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268550
Hyphenated Format 50268-550

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 (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
  • 50 BLISTER PACK in 1 BOX (50268-550-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-550-11)
source: ndc

Packages (1)

50268-550-15 50 BLISTER PACK in 1 BOX (50268-550-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-550-11)

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": "47e74e26-3f97-482a-e063-6394a90a3ac9", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["d9bac244-1725-5bf3-e053-2a95a90ac823"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-550-15)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-550-11)", "package_ndc": "50268-550-15", "marketing_start_date": "20220308"}], "brand_name": "Metformin Hydrochloride", "product_id": "50268-550_47e74e26-3f97-482a-e063-6394a90a3ac9", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "50268-550", "generic_name": "Metformin Hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA078321", "marketing_category": "ANDA", "marketing_start_date": "20220308", "listing_expiration_date": "20271231"}