Sodium Fluoride

Product NDC

47584-002

11-digit product format

475840002

Labeler code

47584

Product ID

47584-002_7cda8776-f781-1eea-e053-2a91aa0ae22e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

SODIUM FLUORIDE F-18

Dosage form

INJECTION

Route

INTRAVENOUS

Labeler

Houston Cyclotron Partners LP dba Cyclotope

Application

ANDA203544

Marketing category

ANDA

Marketing start

2011-12-08

Marketing end

0000-00-00

Substance

SODIUM FLUORIDE F-18

Active strength

200 mCi/mL

Pharmacologic classes

Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record