NDC 75834-500

METFORMIN HYDROCHLORIDE ER

Metformin Hydrochloride

METFORMIN HYDROCHLORIDE ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Nivagen Pharmaceuticals Inc. The primary component is Metformin Hydrochloride.

• Product ID: 75834-500_a85b9b37-34f0-4a0d-e053-2995a90ab1ce
• NDC: 75834-500
• Product Type: Human Prescription Drug
• Proprietary Name: METFORMIN HYDROCHLORIDE ER
• Generic Name: Metformin Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-11-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201991
• Labeler Name: Nivagen 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: 2021-12-31

Packaging

NDC 75834-500-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-500-01)

• Marketing Start Date: 2020-06-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75834-500-05 [75834050005]

Metformin hydrochloride ER TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA201991
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-11-01
• Inactivation Date: 2019-11-27

NDC 75834-500-01 [75834050001]

Metformin hydrochloride ER TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA201991
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-11-01
• Inactivation Date: 2019-11-27

NDC 75834-500-10 [75834050010]

Metformin hydrochloride ER TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA201991
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-11-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: d01b63e6-70e5-4679-b377-1e0fb78a87b5
• Manufacturer:
  • Nivagen Pharmaceuticals Inc
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 860975

Pharmacological Class

• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "METFORMIN HYDROCHLORIDE ER" or generic name "Metformin Hydrochloride"

NDC	Brand Name	Generic Name
75834-500	Metformin hydrochloride ER	Metformin hydrochloride ER
76385-129	Metformin hydrochloride ER	Metformin hydrochloride ER
51655-550	Metformin hydrochloride ER	Metformin hydrochloride ER
51655-562	Metformin hydrochloride ER	Metformin hydrochloride ER
72789-106	Metformin hydrochloride ER	Metformin hydrochloride ER
71610-457	METFORMIN HYDROCHLORIDE ER	METFORMIN HYDROCHLORIDE ER
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
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