Fulvestrant

Product NDC
16714-118
11-digit product format
167140118
Labeler code
16714
Product ID
16714-118_4862589a-faf2-45e6-a4a5-08d2e11d05d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Northstar RxLLC
Application
ANDA205935
Marketing category
ANDA
Marketing start
2019-05-29
Marketing end
2022-05-22
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-118-01ML - Milliliter16714-11890c5e913-dadb-424a-ba8c-d5795c9ea47a12020-03-10
16714-118-02ML - Milliliter16714-118da9879d3-c627-4da2-8a2f-39286a1b3fd812020-03-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-118-02167140118022 SYRINGE, GLASS in 1 CARTON (16714-118-02) > 5 mL in 1 SYRINGE, GLASS (16714-118-01) 2020-02-260000-00-00NoNoCurrent