NDC 35208-001

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 Intellipharmaceutics Corp.. The primary component is Metformin Hydrochloride.

• Product ID: 35208-001_16c446ea-dd07-45ba-b136-0b8b51bd79bb
• NDC: 35208-001
• 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: 2018-09-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202306
• Labeler Name: IntelliPharmaCeutics Corp.
• 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 35208-001-10

1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (35208-001-10)

• Marketing Start Date: 2018-09-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 35208-001-10 [35208000110]

Metformin Hydrochloride Extended Release TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA202306
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-09-11

NDC 35208-001-90 [35208000190]

Metformin Hydrochloride Extended Release TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA202306
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-09-11

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 462198db-084d-4fb9-b5ca-86a8bacc9284
• Manufacturer:
  • IntelliPharmaCeutics Corp.
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 860981
  • 860975
• UPC Code:
  • 0300000000001

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