metformin hydrochloride

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride
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 72789-105
Product ID 72789-105_4af6702a-f722-1549-e063-6294a90a6615
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207427
Listing Expiration 2027-12-31
Marketing Start 2018-07-17

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789105
Hyphenated Format 72789-105

Supplemental Identifiers

RxCUI
860975 860981
UPC
0372789106908 0372789105604
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 ANDA207427 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-01)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-60)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-82)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-90)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-93)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-95)
source: ndc

Packages (6)

72789-105-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-01) 72789-105-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-60) 72789-105-82 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-82) 72789-105-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-90) 72789-105-93 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-93) 72789-105-95 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-95)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin hydrochloride, Metformin hydrochloride ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4af6702a-f722-1549-e063-6294a90a6615", "openfda": {"upc": ["0372789106908", "0372789105604"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["17050df5-9e95-4e1b-ac75-34add289b139"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-01)", "package_ndc": "72789-105-01", "marketing_start_date": "20210510"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-60)", "package_ndc": "72789-105-60", "marketing_start_date": "20230522"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-82)", "package_ndc": "72789-105-82", "marketing_start_date": "20210129"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-90)", "package_ndc": "72789-105-90", "marketing_start_date": "20200824"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-93)", "package_ndc": "72789-105-93", "marketing_start_date": "20200824"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-95)", "package_ndc": "72789-105-95", "marketing_start_date": "20210129"}], "brand_name": "Metformin hydrochloride", "product_id": "72789-105_4af6702a-f722-1549-e063-6294a90a6615", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "72789-105", "generic_name": "Metformin hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA207427", "marketing_category": "ANDA", "marketing_start_date": "20180717", "listing_expiration_date": "20271231"}