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Sestamibi

Sestamibi for the preparation of Tc99m Sestamibi injection)

Approved
Approval ID

5ef52f7c-042e-4f84-8048-5249bd01fade

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 23, 2012

Manufacturers
FDA

AnazaoHealth Corporation

DUNS: 011038762

Products 1

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

Sestamibi

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51808-208
Product Classification
G
Generic Name
Sestamibi
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 13, 2012
FDA Product Classification

INGREDIENTS (5)

TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 3.9 mg in 1 1
Code: B22547B95K
Classification: IACT
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATEActive
Quantity: 1.5 mg in 1 1
Code: N6OU7HJ70P
Classification: ACTIB
MANNITOLInactive
Quantity: 30 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
STANNOUS CHLORIDEInactive
Quantity: 0.112 mg in 1 1
Code: 1BQV3749L5
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Quantity: 1.5 mg in 1 1
Code: ZT934N0X4W
Classification: IACT

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Sestamibi - FDA Drug Approval Details