NDC 64764-570

Brintellix

Vortioxetine

Brintellix is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Vortioxetine Hydrobromide.

• Product ID: 64764-570_cc70d6dd-e54b-483d-83f5-762a6cce455a
• NDC: 64764-570
• Product Type: Human Prescription Drug
• Proprietary Name: Brintellix
• Generic Name: Vortioxetine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-10-02
• Marketing Category: NDA / NDA
• Application Number: NDA204447
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: VORTIOXETINE HYDROBROMIDE
• Active Ingredient Strength: 15 mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 64764-570-07

1 BOTTLE in 1 CARTON (64764-570-07) > 7 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2013-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64764-570-09 [64764057009]

Brintellix TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204447
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-02
• Marketing End Date: 2019-08-15

NDC 64764-570-30 [64764057030]

Brintellix TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204447
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-02
• Marketing End Date: 2019-08-15

NDC 64764-570-07 [64764057007]

Brintellix TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204447
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-02
• Marketing End Date: 2019-08-15

NDC 64764-570-90 [64764057090]

Brintellix TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204447
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-02
• Marketing End Date: 2019-08-15

NDC 64764-570-77 [64764057077]

Brintellix TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204447
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-02
• Marketing End Date: 2019-08-15

Drug Details

Active Ingredients

Ingredient	Strength
VORTIOXETINE HYDROBROMIDE	15 mg/1

OpenFDA Data

• SPL SET ID: 4b0700c9-b417-4c3a-b36f-de461e125bd3
• Manufacturer:
  • Takeda Pharmaceuticals America, Inc.
• UNII:
  • TKS641KOAY
• RxNorm Concept Unique ID - RxCUI:
  • 1439844
  • 1439842
  • 1439840
  • 1439808
  • 1439829
  • 1439838
  • 1439810
  • 1439812
• UPC Code:
  • 0364764560300
  • 0364764580308
  • 0364764550301
  • 0364764570309

NDC Crossover Matching brand name "Brintellix" or generic name "Vortioxetine"

NDC	Brand Name	Generic Name
64764-550	Brintellix	vortioxetine
64764-560	Brintellix	vortioxetine
64764-570	Brintellix	vortioxetine
64764-580	Brintellix	vortioxetine
55154-0256	Trintellix	vortioxetine
55154-0257	Trintellix	vortioxetine
64764-720	Trintellix	vortioxetine
64764-730	Trintellix	vortioxetine
64764-750	Trintellix	vortioxetine