metformin hydrochloride extended release

Generic: metformin hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride extended release
Generic Name metformin hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-009
Product ID 72789-009_3143f509-5529-ee8b-e063-6294a90aeed3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090295
Listing Expiration 2026-12-31
Marketing Start 2016-05-12

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789009
Hyphenated Format 72789-009

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 (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA090295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-90)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-93)
source: ndc

Packages (4)

72789-009-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-30) 72789-009-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-60) 72789-009-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-90) 72789-009-93 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-93)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE EXTENDED RELEASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3143f509-5529-ee8b-e063-6294a90aeed3", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["14f3091c-f243-4364-b433-727c7d4ef8d5"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-30)", "package_ndc": "72789-009-30", "marketing_start_date": "20190918"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-60)", "package_ndc": "72789-009-60", "marketing_start_date": "20190920"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-90)", "package_ndc": "72789-009-90", "marketing_start_date": "20190913"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-93)", "package_ndc": "72789-009-93", "marketing_start_date": "20190913"}], "brand_name": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE", "product_id": "72789-009_3143f509-5529-ee8b-e063-6294a90aeed3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "72789-009", "generic_name": "Metformin Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090295", "marketing_category": "ANDA", "marketing_start_date": "20160512", "listing_expiration_date": "20261231"}