NDC 70010-491

Metformin

Metformin Er 500 Mg

Metformin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Granules Pharmaceuticals Inc.. The primary component is Metformin Hydrochloride.

• Product ID: 70010-491_3c25fd44-75e2-4cc3-8aeb-d11d957f8b67
• NDC: 70010-491
• Product Type: Human Prescription Drug
• Proprietary Name: Metformin
• Generic Name: Metformin Er 500 Mg
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209313
• Labeler Name: Granules 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: 2020-12-31

Packaging

NDC 70010-491-01

100 TABLET in 1 BOTTLE (70010-491-01)

• Marketing Start Date: 2019-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70010-491-10 [70010049110]

Metformin TABLET

• Marketing Category: ANDA
• Application Number: ANDA209313
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-18

NDC 70010-491-18 [70010049118]

Metformin TABLET

• Marketing Category: ANDA
• Application Number: ANDA209313
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-18

NDC 70010-491-19 [70010049119]

Metformin TABLET

• Marketing Category: ANDA
• Application Number: ANDA209313
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-25

NDC 70010-491-09 [70010049109]

Metformin TABLET

• Marketing Category: ANDA
• Application Number: ANDA209313
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-16

NDC 70010-491-01 [70010049101]

Metformin TABLET

• Marketing Category: ANDA
• Application Number: ANDA209313
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-18

NDC 70010-491-05 [70010049105]

Metformin TABLET

• Marketing Category: ANDA
• Application Number: ANDA209313
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-18

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 6d6ee6f8-9650-ff4f-e053-2991aa0acf19
• Manufacturer:
  • Granules Pharmaceuticals Inc.
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 860981
  • 860975
• UPC Code:
  • 0370010491106
  • 0370010491014

Pharmacological Class

• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "Metformin" or generic name "Metformin Er 500 Mg"

NDC	Brand Name	Generic Name
50742-633	Metformin	metformin
50742-634	Metformin	metformin
68071-2779	Metformin	Metformin ER 500 mg
68645-595	Metformin	Metformin ER 500 mg
70010-491	Metformin	Metformin ER 500 mg
70010-492	Metformin	Metformin ER 750 mg
70518-3570	Metformin	Metformin ER 500 mg
71610-613	Metformin	Metformin ER 500 mg
62207-491	Metformin ER 500 mg	Metformin ER 500 mg
0378-6001	Metformin Hydrochloride	metformin
0378-6002	Metformin Hydrochloride	metformin
65162-174	Metformin Hydrochloride	Metformin
65162-175	Metformin Hydrochloride	Metformin
65162-177	Metformin Hydrochloride	Metformin
0615-8105	Metformin Hydrochoride	Metformin