azacitidine for

Product NDC
69097-805
11-digit product format
690970805
Labeler code
69097
Product ID
69097-805_c5dc2bd3-9762-46f7-a2c7-7a9c6f951ea2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azacitidine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Cipla USA Inc.
Application
ANDA207518
Marketing category
ANDA
Marketing start
2019-03-26
Marketing end
0000-00-00
Substance
AZACITIDINE
Active strength
100 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
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
69097-805-40EA - Each69097-805af0d8157-67cc-460a-8e7a-cb7196e34b7512019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-805AZACITIDINE FOR (AZACITIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIPLA USA INC.]5Legacy NDC20230301_52b19d87-b646-4a00-bdd4-ac826860b719.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-805-40690970805401 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (69097-805-40) 2019-03-260000-00-00NoNoCurrent