NDC 43598-348

Decitabine

Decitabine

Decitabine is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Dr.reddy's Laboratories Inc.. The primary component is Decitabine.

• Product ID: 43598-348_206c1019-7ff4-50ab-6108-da6ffc0060d8
• NDC: 43598-348
• Product Type: Human Prescription Drug
• Proprietary Name: Decitabine
• Generic Name: Decitabine
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2013-07-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203131
• Labeler Name: Dr.Reddy's Laboratories Inc.
• Substance Name: DECITABINE
• Active Ingredient Strength: 50 mg/10mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43598-348-37

1 VIAL, SINGLE-USE in 1 CARTON (43598-348-37) > 10 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2013-07-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43598-348-37 [43598034837]

Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203131
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-07-11

Drug Details

Active Ingredients

Ingredient	Strength
DECITABINE	50 mg/10mL

OpenFDA Data

• SPL SET ID: 99cea19b-cabf-8a6d-b2ef-f04920952b93
• Manufacturer:
  • Dr.Reddy's Laboratories Inc.
• UNII:
  • 776B62CQ27
• RxNorm Concept Unique ID - RxCUI:
  • 636631

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0143-9385	decitabine	decitabine
0781-3139	Decitabine	Decitabine
0781-3296	Decitabine	Decitabine
16714-749	Decitabine	Decitabine
16714-928	Decitabine	Decitabine
16729-224	Decitabine	decitabine
25021-231	decitabine	decitabine
42737-110	Decitabine	Decitabine
43598-348	Decitabine	Decitabine
43598-427	Decitabine	Decitabine
47335-361	decitabine	decitabine
50742-430	DECITABINE	decitabine
55111-556	Decitabine	Decitabine
55150-376	Decitabine	Decitabine
68001-347	Decitabine	Decitabine
69097-285	Decitabine	Decitabine
67457-316	Decitabine	Decitabine
64679-067	Decitabine	Decitabine
68001-422	Decitabine	Decitabine
69539-115	Decitabine	Decitabine
63323-825	Decitabine	Decitabine
68180-738	decitabine	decitabine
70121-1644	Decitabine	Decitabine
72205-031	Decitabine	Decitabine
72205-036	Decitabine	Decitabine
75834-190	DECITABINE	DECITABINE
72603-107	Decitabine	Decitabine
59148-046	Dacogen	decitabine