NDC 0904-5794

Metformin Hydrochloride Extended Release

Metformin Hydrochloride

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

• Product ID: 0904-5794_0cfa0079-8df3-432a-a5ae-f0bec7d2aad9
• NDC: 0904-5794
• Product Type: Human Prescription Drug
• Proprietary Name: Metformin Hydrochloride Extended Release
• Generic Name: Metformin Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2009-06-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076706
• Labeler Name: Major Pharmaceuticals
• 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 0904-5794-61

100 BLISTER PACK in 1 CARTON (0904-5794-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2009-06-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-5794-61 [00904579461]

Metformin Hydrochloride Extended Release TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076706
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-10
• Marketing End Date: 2019-01-18

NDC 0904-5794-40 [00904579440]

Metformin Hydrochloride Extended Release TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076706
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-06-10
• Marketing End Date: 2018-10-31

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 37a431ab-466c-4f8b-b06d-826d35fd3710
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 860975
• UPC Code:
  • 0309045794616

Pharmacological Class

• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "Metformin Hydrochloride Extended Release" or generic name "Metformin Hydrochloride"

NDC	Brand Name	Generic Name
68071-3111	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
68788-6932	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
68788-7337	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
70518-0899	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
71335-0293	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
71335-0889	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
0904-5794	Metformin Hydrochloride Extended Release	Metformin Hydrochloride Extended Release
35208-001	Metformin Hydrochloride Extended Release	Metformin Hydrochloride Extended Release
35208-002	Metformin Hydrochloride Extended Release	Metformin Hydrochloride Extended Release
43063-902	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
49483-624	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
49483-623	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
60760-623	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
61919-450	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
71335-1310	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
72789-009	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
70518-2480	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
70934-334	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
70934-309	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
71610-454	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
72189-064	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE EXTENDED RELEASE
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