metformin hydrochloride

Generic: metformin hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

metformin hydrochloride 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-779
Product ID 63187-779_103cbde3-9398-44e5-b27e-c4c77a46e97a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201991
Listing Expiration 2027-12-31
Marketing Start 2013-03-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187779
Hyphenated Format 63187-779

Supplemental Identifiers

RxCUI
860975
UPC
0363187779900
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 ANDA201991 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-60)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-78)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-90)
source: ndc

Packages (4)

63187-779-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-30) 63187-779-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-60) 63187-779-78 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-78) 63187-779-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-90)

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": "103cbde3-9398-44e5-b27e-c4c77a46e97a", "openfda": {"upc": ["0363187779900"], "unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["3ba957ea-28ed-4a61-a318-98064ea4944d"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-30)", "package_ndc": "63187-779-30", "marketing_start_date": "20161101"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-60)", "package_ndc": "63187-779-60", "marketing_start_date": "20250423"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-78)", "package_ndc": "63187-779-78", "marketing_start_date": "20260105"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-90)", "package_ndc": "63187-779-90", "marketing_start_date": "20161101"}], "brand_name": "Metformin hydrochloride", "product_id": "63187-779_103cbde3-9398-44e5-b27e-c4c77a46e97a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "63187-779", "generic_name": "Metformin hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA201991", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20271231"}