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, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-784
Product ID 71205-784_ab4b854a-723a-416f-9eff-9c9e7dbac29f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203769
Listing Expiration 2026-12-31
Marketing Start 2017-11-21

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205784
Hyphenated Format 71205-784

Supplemental Identifiers

RxCUI
861004 861007
UPC
0371205783907 0371205784607
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 ANDA203769 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-78)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-90)
source: ndc

Packages (4)

71205-784-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-30) 71205-784-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-60) 71205-784-78 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-78) 71205-784-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-90)

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": "ab4b854a-723a-416f-9eff-9c9e7dbac29f", "openfda": {"upc": ["0371205783907", "0371205784607"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007"], "spl_set_id": ["928ef685-80cb-42a9-a155-3c21c9b1dd67"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-30)", "package_ndc": "71205-784-30", "marketing_start_date": "20230329"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-60)", "package_ndc": "71205-784-60", "marketing_start_date": "20230329"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-78)", "package_ndc": "71205-784-78", "marketing_start_date": "20240325"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-90)", "package_ndc": "71205-784-90", "marketing_start_date": "20230329"}], "brand_name": "Metformin Hydrochloride", "product_id": "71205-784_ab4b854a-723a-416f-9eff-9c9e7dbac29f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71205-784", "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": "ANDA203769", "marketing_category": "ANDA", "marketing_start_date": "20171121", "listing_expiration_date": "20261231"}