NDC 70934-134

Metformin Hydrochloride

Metformin Hydrochloride

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

• Product ID: 70934-134_807b7ecc-2f30-3e38-e053-2991aa0a3fb2
• NDC: 70934-134
• Product Type: Human Prescription Drug
• Proprietary Name: Metformin Hydrochloride
• Generic Name: Metformin Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2018-06-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078321
• Labeler Name: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
• Substance Name: METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70934-134-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-134-30)

• Marketing Start Date: 2018-06-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70934-134-60 [70934013460]

Metformin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078321
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-02

NDC 70934-134-30 [70934013430]

Metformin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078321
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-06

NDC 70934-134-98 [70934013498]

Metformin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078321
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-25

NDC 70934-134-90 [70934013490]

Metformin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078321
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-21

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 70a765db-7cf2-2958-e053-2991aa0adcb5
• Manufacturer:
  • Denton Pharma, Inc. DBA Northwind Pharmaceuticals
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 860975

Pharmacological Class

• Biguanide [EPC]
• Biguanides [CS]
• Biguanide [EPC]
• Biguanides [CS]

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

NDC	Brand Name	Generic Name
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
0378-6001	Metformin Hydrochloride	metformin
0378-6002	Metformin Hydrochloride	metformin
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
67877-217	Metformin Hydrochloride	Metformin Hydrochloride
67877-221	Metformin Hydrochloride	Metformin Hydrochloride
67877-218	Metformin Hydrochloride	Metformin Hydrochloride
67877-159	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
67877-414	Metformin Hydrochloride	Metformin Hydrochloride
67877-413	Metformin Hydrochloride	Metformin Hydrochloride
68071-1781	Metformin hydrochloride	Metformin hydrochloride
68071-1419	Metformin hydrochloride	Metformin hydrochloride
68071-1815	Metformin hydrochloride	Metformin hydrochloride
68071-3117	Metformin hydrochloride	Metformin hydrochloride
68071-3200	Metformin hydrochloride	Metformin hydrochloride
68071-1774	Metformin hydrochloride	Metformin hydrochloride
68071-3226	Metformin Hydrochloride	Metformin Hydrochloride
68071-1927	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
68071-3370	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
68071-3126	Metformin hydrochloride	Metformin hydrochloride
68071-3212	Metformin Hydrochloride	Metformin Hydrochloride
68071-4153	Metformin Hydrochloride	Metformin Hydrochloride
68071-4525	Metformin hydrochloride	Metformin hydrochloride
68071-4560	Metformin hydrochloride	Metformin hydrochloride
68071-4605	Metformin hydrochloride	Metformin hydrochloride
68071-4270	Metformin Hydrochloride	Metformin Hydrochloride