NDC 43817-906

Azacitidine

Azacitidine

Azacitidine is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Panacea Biotec Ltd.. The primary component is Azacitidine.

Product ID43817-906_2710b21d-1a7b-4031-8d52-80b8653b153c
NDC43817-906
Product TypeHuman Prescription Drug
Proprietary NameAzacitidine
Generic NameAzacitidine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-05-06
Marketing CategoryANDA / ANDA
Application NumberANDA207234
Labeler NamePanacea Biotec Ltd.
Substance NameAZACITIDINE
Active Ingredient Strength100 mg/50mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43817-906-01

1 VIAL, SINGLE-DOSE in 1 CARTON (43817-906-01) > 50 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-05-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43817-906-01 [43817090601]

Azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA207234
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-06

Drug Details

Active Ingredients

IngredientStrength
AZACITIDINE100 mg/50mL

OpenFDA Data

SPL SET ID:9abb489d-ce54-4140-83f6-b756f00b0967
Manufacturer
UNII

Pharmacological Class

  • Nucleic Acid Synthesis Inhibitors [MoA]
  • Nucleoside Metabolic Inhibitor [EPC]
  • Nucleic Acid Synthesis Inhibitors [MoA]
  • Nucleoside Metabolic Inhibitor [EPC]

NDC Crossover Matching brand name "Azacitidine" or generic name "Azacitidine"

NDCBrand NameGeneric Name
0143-9606AzacitidineAzacitidine
0591-2897AzacitidineAzacitidine
0781-3253Azacitidineazacitidine
0781-9253Azacitidineazacitidine
16714-578AzacitidineAzacitidine
16714-777AzacitidineAzacitidine
16714-927AzacitidineAzacitidine
16729-306AzacitidineAzacitidine
43598-143AzacitidineAzacitidine
43598-305AzacitidineAzacitidine
43598-465AzacitidineAzacitidine
43598-678AZACITIDINEAZACITIDINE
43817-906AzacitidineAzacitidine
51991-797AzacitidineAzacitidine
55150-393AZACITIDINEAZACITIDINE
68001-313AzacitidineAzacitidine
69097-368AzacitidineAzacitidine
72485-201AZACITIDINEAZACITIDINE
63323-771AzacitidineAzacitidine
63759-0003AZACITIDINEAZACITIDINE
64679-096AZACITIDINEAZACITIDINE
67457-254AzacitidineAzacitidine
72606-558AZACITIDINEAZACITIDINE
71288-115AzacitidineAzacitidine
59572-730ONUREGazacitidine
59572-740ONUREGazacitidine
59572-102VIDAZAazacitidine
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