NDC 0006-5374

SEGLUROMET

Ertugliflozin And Metformin Hydrochloride

SEGLUROMET is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Ertugliflozin Pidolate; Metformin Hydrochloride.

• Product ID: 0006-5374_104d4fc3-1be2-454b-9582-becbd99b3c1a
• NDC: 0006-5374
• Product Type: Human Prescription Drug
• Proprietary Name: SEGLUROMET
• Generic Name: Ertugliflozin And Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-12-19
• Marketing Category: NDA / NDA
• Application Number: NDA209806
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 8 mg/1; mg/1
• Pharm Classes: Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0006-5374-03

60 TABLET, FILM COATED in 1 BOTTLE (0006-5374-03)

• Marketing Start Date: 2017-12-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-5374-08 [00006537408]

SEGLUROMET TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209806
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-19

NDC 0006-5374-09 [00006537409]

SEGLUROMET TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209806
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-19

NDC 0006-5374-07 [00006537407]

SEGLUROMET TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209806
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-19

NDC 0006-5374-06 [00006537406]

SEGLUROMET TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209806
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-19

NDC 0006-5374-03 [00006537403]

SEGLUROMET TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209806
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-19

Drug Details

Active Ingredients

Ingredient	Strength
ERTUGLIFLOZIN PIDOLATE	7.5 mg/1

OpenFDA Data

• SPL SET ID: a6aeb99a-ce49-4125-90ce-642df3f1ebad
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • MLU731K321
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 1992685
  • 1992695
  • 1992693
  • 1992691
  • 1992698
  • 1992701
  • 1992700
  • 1992703
• UPC Code:
  • 0300065374031
  • 0300065373034
  • 0300065370033
  • 0300065369037

Pharmacological Class

• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "SEGLUROMET" or generic name "Ertugliflozin And Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0006-5369	SEGLUROMET	ertugliflozin and metformin hydrochloride
0006-5370	SEGLUROMET	ertugliflozin and metformin hydrochloride
0006-5373	SEGLUROMET	ertugliflozin and metformin hydrochloride
0006-5374	SEGLUROMET	ertugliflozin and metformin hydrochloride
50090-6217	SEGLUROMET	ertugliflozin and metformin hydrochloride
50090-6218	SEGLUROMET	ertugliflozin and metformin hydrochloride
50090-6231	SEGLUROMET	ertugliflozin and metformin hydrochloride