NDC 0143-9385

decitabine

Decitabine

decitabine is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Decitabine.

Product ID0143-9385_f03251b9-a685-4db3-9ca3-7b17ac29a0b8
NDC0143-9385
Product TypeHuman Prescription Drug
Proprietary Namedecitabine
Generic NameDecitabine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-04-15
Marketing CategoryANDA /
Application NumberANDA213472
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameDECITABINE
Active Ingredient Strength50 mg/1
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0143-9385-01

1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9385-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing Start Date2022-04-15
NDC Exclude FlagN
Sample Package?N

Drug Details

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.