NDC 68012-004

Glumetza

Metformin Hydrochloride

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

• Product ID: 68012-004_039bd4a8-cf35-4946-8079-ca0aef70b829
• NDC: 68012-004
• Product Type: Human Prescription Drug
• Proprietary Name: Glumetza
• Generic Name: Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2018-03-20
• Marketing Category: NDA / NDA
• Application Number: NDA021748
• Labeler Name: Santarus, 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 68012-004-50

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-004-50)

• Marketing Start Date: 2018-03-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68012-004-50 [68012000450]

Glumetza TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021748
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-03-20

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: fb832474-88d9-4e29-95cd-fbc446944cc4
• Manufacturer:
  • Santarus, Inc.
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 861018
  • 1807915
  • 1807888
  • 861015

Pharmacological Class

• Biguanide [EPC]
• Biguanides [CS]

Medicade Reported Pricing

68012000450 GLUMETZA ER 500 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
68012-002	Glumetza	Glumetza
68012-003	Glumetza	Glumetza
68012-004	Glumetza	Glumetza
13913-002	Glumetza	Glumetza
13913-003	Glumetza	Glumetza
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
0615-7847	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
0615-7982	Metformin Hydrochloride	Metformin Hydrochloride
0615-8015	Metformin Hydrochloride	Metformin Hydrochloride