NDC 55289-211

GLUCOPHAGE

Metformin Hydrochloride

GLUCOPHAGE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Metformin Hydrochloride.

• Product ID: 55289-211_7b342c78-cd24-27f4-e053-2a91aa0a621a
• NDC: 55289-211
• Product Type: Human Prescription Drug
• Proprietary Name: GLUCOPHAGE
• Generic Name: Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA020357
• Labeler Name: PD-Rx Pharmaceuticals, Inc.
• Substance Name: METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55289-211-60

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-211-60)

• Marketing Start Date: 2009-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-211-60 [55289021160]

GLUCOPHAGE TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020357
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-30
• Marketing End Date: 2019-09-11

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: b14ef252-fe31-4dfd-840d-2588f591cb7c
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 861007
  • 861008

Pharmacological Class

• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "GLUCOPHAGE" or generic name "Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0087-6060	GLUCOPHAGE	METFORMIN HYDROCHLORIDE
0087-6063	GLUCOPHAGE	METFORMIN HYDROCHLORIDE
0087-6064	GLUCOPHAGE	METFORMIN HYDROCHLORIDE
0087-6070	GLUCOPHAGE	METFORMIN HYDROCHLORIDE
0087-6071	GLUCOPHAGE	METFORMIN HYDROCHLORIDE
55289-211	GLUCOPHAGE	GLUCOPHAGE
0093-1048	Metformin Hydrochloride	Metformin Hydrochloride
0093-1049	Metformin Hydrochloride	Metformin Hydrochloride
0093-7212	Metformin Hydrochloride	Metformin Hydrochloride
0093-7214	Metformin Hydrochloride	Metformin Hydrochloride
0093-7267	Metformin Hydrochloride	Metformin Hydrochloride
0179-1979	Metformin Hydrochloride	Metformin Hydrochloride
0185-4416	metformin hydrochloride	metformin hydrochloride
0378-7185	Metformin Hydrochloride	metformin hydrochloride
0378-7186	Metformin Hydrochloride	metformin hydrochloride
0378-7187	Metformin Hydrochloride	metformin hydrochloride
0440-5739	Metformin Hydrochloride	Metformin Hydrochloride
0440-5745	Metformin Hydrochloride	Metformin Hydrochloride
0440-5746	Metformin Hydrochloride	Metformin Hydrochloride
0591-2411	Metformin Hydrochloride	Metformin Hydrochloride
0591-2412	Metformin Hydrochloride	Metformin Hydrochloride
0591-2719	Metformin Hydrochloride	Metformin Hydrochloride
0591-2720	Metformin Hydrochloride	Metformin Hydrochloride
0615-5583	Metformin Hydrochloride	Metformin Hydrochloride
0615-7626	Metformin Hydrochloride	Metformin Hydrochloride
0615-7627	Metformin Hydrochloride	Metformin Hydrochloride
0615-7628	Metformin Hydrochloride	Metformin Hydrochloride
0615-7661	Metformin Hydrochloride	Metformin Hydrochloride
0615-7662	Metformin Hydrochloride	Metformin Hydrochloride
0615-7663	Metformin Hydrochloride	Metformin Hydrochloride
0615-7847	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
0615-7982	Metformin Hydrochloride	Metformin Hydrochloride
0615-8015	Metformin Hydrochloride	Metformin Hydrochloride