NDC 59148-046

Dacogen

Decitabine

Dacogen is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc.. The primary component is Decitabine.

• Product ID: 59148-046_4d5b6a30-b467-4236-bef9-4c339aab5921
• NDC: 59148-046
• Product Type: Human Prescription Drug
• Proprietary Name: Dacogen
• Generic Name: Decitabine
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2006-05-02
• Marketing Category: NDA / NDA
• Application Number: NDA021790
• Labeler Name: Otsuka America Pharmaceutical, Inc.
• Substance Name: DECITABINE
• Active Ingredient Strength: 50 mg/20mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 59148-046-70

1 VIAL in 1 CARTON (59148-046-70) > 20 mL in 1 VIAL

• Marketing Start Date: 2006-05-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59148-046-70 [59148004670]

Dacogen INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021790
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-05-02

Drug Details

Active Ingredients

Ingredient	Strength
DECITABINE	50 mg/20mL

OpenFDA Data

• SPL SET ID: deb4a13c-855b-4372-9778-6e81da598df6
• Manufacturer:
  • Otsuka America Pharmaceutical, Inc.
• UNII:
  • 776B62CQ27
• RxNorm Concept Unique ID - RxCUI:
  • 644989
  • 636631

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
59148-046	Dacogen	decitabine
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