Fulvestrant

Product NDC
67457-311
11-digit product format
674570311
Labeler code
67457
Product ID
67457-311_67238290-4068-4ce9-b79c-5425906c3009
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Mylan Institutional LLC
Application
ANDA208811
Marketing category
ANDA
Marketing start
2019-09-09
Marketing end
0000-00-00
Substance
FULVESTRANT
Active strength
50 mg/mL
Pharmacologic classes
Estrogen Receptor Antagonist [EPC],Estrogen Receptor Antagonists [MoA],Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-311-00ML - Milliliter67457-3113293de63-f22d-4e04-bfa9-49a31be9d3da12019-10-07
67457-311-05ML - Milliliter67457-311a6b2b9e9-e0aa-405c-8da9-7d7ae235963312019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-311-05674570311052 SYRINGE, GLASS in 1 CARTON (67457-311-05) > 5 mL in 1 SYRINGE, GLASS (67457-311-00) 2019-09-090000-00-00NoNoCurrent