NDC 50742-430

DECITABINE

Decitabine

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

• Product ID: 50742-430_120e8fd3-81fc-41fb-9517-50d014eb9f66
• NDC: 50742-430
• 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: 2019-09-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210984
• Labeler Name: Ingenus Pharmaceuticals, LLC
• Substance Name: DECITABINE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50742-430-01

1 VIAL in 1 CARTON (50742-430-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• Marketing Start Date: 2019-09-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50742-430-01 [50742043001]

DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA210984
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-09-25

Drug Details

Active Ingredients

Ingredient	Strength
DECITABINE	50 mg/1

OpenFDA Data

• SPL SET ID: b3a26585-e247-4b2e-a4ce-817b3aac2ff3
• Manufacturer:
  • Ingenus Pharmaceuticals, LLC
• UNII:
  • 776B62CQ27
• RxNorm Concept Unique ID - RxCUI:
  • 636631
• UPC Code:
  • 0350742430017

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