TECHNETIUM TC 99M SESTAMIBI

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

DUNS Number

080981460

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Jubilant Draximage (USA) Inc.

Registrant

Jubilant Draximage (USA) Inc.

DUNS Number

246762764

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

NDC Product Code

45548-141

Application Number

ANDA078806

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

August 13, 2017

Ingredients

Code: 971Z4W1S09Class: ACTIRQuantity: 1 mg in 1 mL

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 2.6 mg in 1 mL

Stannous ChlorideInactive

Code: 1BQV3749L5Class: IACTQuantity: 0.075 mg in 1 mL

Cysteine HydrochlorideInactive

Code: ZT934N0X4WClass: IACTQuantity: 1 mg in 1 mL

MannitolInactive

Code: 3OWL53L36AClass: IACTQuantity: 20 mg in 1 mL