RIZATRIPTAN BENZOATE

These highlights do not include all the information needed to use RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS, USP safely and effectively. See full prescribing information for RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS, USP. RIZATRIPTAN BENZOATE orally disintegrating tablets, USP Initial U.S. Approval: 1998

Approved

Approval ID

9c70370d-72ac-e062-e25c-97d57e6397ab

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 2, 2021

Manufacturers

FDA

Panacea Biotec Limited

DUNS: 650090566

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

rizatriptan benzoate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43817-135

Application NumberANDA204722

Product Classification

Marketing Category

C73584

Generic Name

rizatriptan benzoate

Product Specifications

Route of AdministrationORAL

Effective DateMarch 2, 2021

FDA Product Classification

INGREDIENTS (13)

MENTHOLInactive

Code: L7T10EIP3A

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

RIZATRIPTAN BENZOATEActive

Quantity: 10 mg in 1 1

Code: WR978S7QHH

Classification: ACTIM

ASPARTAMEInactive

Code: Z0H242BBR1

Classification: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92J

Classification: IACT

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

rizatriptan benzoate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43817-133

Application NumberANDA204722

Product Classification

Marketing Category

C73584

Generic Name

rizatriptan benzoate

Product Specifications

Route of AdministrationORAL

Effective DateMarch 2, 2021

FDA Product Classification

INGREDIENTS (13)

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MENTHOLInactive

Code: L7T10EIP3A

Classification: IACT

ASPARTAMEInactive

Code: Z0H242BBR1

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92J

Classification: IACT

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

RIZATRIPTAN BENZOATEActive

Quantity: 5 mg in 1 1

Code: WR978S7QHH

Classification: ACTIM

AI-Powered Research

Premium Access

RIZATRIPTAN BENZOATE

Products 2

rizatriptan benzoate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

rizatriptan benzoate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

MedPath

Product

Company

Legal