Decitabine

Product NDC
16714-928
11-digit product format
167140928
Labeler code
16714
Product ID
16714-928_265aac36-0da5-e1a1-5a20-82c21d81bda6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Northstar Rx LLC
Application
ANDA203131
Marketing category
ANDA
Marketing start
2019-02-18
Marketing end
0000-00-00
Substance
DECITABINE
Active strength
50 mg/10mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-928-01EA - Each16714-9288923180b-a8a6-4f7b-a4dd-c85fe94cc7f612019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-928-01167140928011 VIAL, SINGLE-DOSE in 1 CARTON (16714-928-01) > 10 mL in 1 VIAL, SINGLE-DOSE2019-02-180000-00-00NoNoCurrent