NDC 0591-2411

Metformin Hydrochloride

Metformin Hydrochloride

Metformin Hydrochloride is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Metformin Hydrochloride.

• Product ID: 0591-2411_1ee5baf7-7aab-473d-bebc-056eb09f5b9d
• NDC: 0591-2411
• Product Type: Human Prescription Drug
• Proprietary Name: Metformin Hydrochloride
• Generic Name: Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-05-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203755
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Biguanide [EPC], Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0591-2411-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2411-01)

• Marketing Start Date: 2017-05-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-2411-10 [00591241110]

Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA203755
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-15
• Marketing End Date: 2017-05-15

NDC 0591-2411-30 [00591241130]

Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA203755
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-15
• Marketing End Date: 2017-05-15

NDC 0591-2411-01 [00591241101]

Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA203755
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-05-15

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 40fa26bc-ee0d-4b6d-9077-f909d84453e6
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 1807915
  • 1807888
• UPC Code:
  • 0305912411303
  • 0305912412300

Pharmacological Class

• 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