NDC 42737-110

Decitabine

Decitabine

Decitabine is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Chemi Pharma Llc. The primary component is Decitabine.

Product ID42737-110_7086b718-9a0b-4f19-8267-4f5da5e6f308
NDC42737-110
Product TypeHuman Prescription Drug
Proprietary NameDecitabine
Generic NameDecitabine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA206033
Labeler NameChemi Pharma LLC
Substance NameDECITABINE
Active Ingredient Strength50 mg/20mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42737-110-01

1 VIAL, SINGLE-USE in 1 CARTON (42737-110-01) > 20 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2019-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42737-110-01 [42737011001]

Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206033
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-31
Marketing End Date2019-12-05

Drug Details

Active Ingredients

IngredientStrength
DECITABINE50 mg/20mL

Pharmacological Class

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

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

NDCBrand NameGeneric Name
0143-9385decitabinedecitabine
0781-3139DecitabineDecitabine
0781-3296DecitabineDecitabine
16714-749DecitabineDecitabine
16714-928DecitabineDecitabine
16729-224Decitabinedecitabine
25021-231decitabinedecitabine
42737-110DecitabineDecitabine
43598-348DecitabineDecitabine
43598-427DecitabineDecitabine
47335-361decitabinedecitabine
50742-430DECITABINEdecitabine
55111-556DecitabineDecitabine
55150-376DecitabineDecitabine
68001-347DecitabineDecitabine
69097-285DecitabineDecitabine
67457-316DecitabineDecitabine
64679-067DecitabineDecitabine
68001-422DecitabineDecitabine
69539-115DecitabineDecitabine
63323-825DecitabineDecitabine
68180-738decitabinedecitabine
70121-1644DecitabineDecitabine
72205-031DecitabineDecitabine
72205-036DecitabineDecitabine
75834-190DECITABINEDECITABINE
72603-107DecitabineDecitabine
59148-046Dacogendecitabine
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.