NDC 68083-337

Cytarabine

Cytarabine

Cytarabine is a Intrathecal; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Cytarabine.

• Product ID: 68083-337_0f861c4a-a287-4001-87bc-51ff05b9b011
• NDC: 68083-337
• Product Type: Human Prescription Drug
• Proprietary Name: Cytarabine
• Generic Name: Cytarabine
• Dosage Form: Injection, Solution
• Route of Administration: INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2019-12-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211938
• Labeler Name: Gland Pharma Limited
• Substance Name: CYTARABINE
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68083-337-01

1 VIAL, SINGLE-DOSE in 1 CARTON (68083-337-01) > 20 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-12-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-337-01 [68083033701]

Cytarabine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA211938
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-12-23

Drug Details

Active Ingredients

Ingredient	Strength
CYTARABINE	100 mg/mL

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
61703-303	CYTARABINE	CYTARABINE
61703-304	Cytarabine	CYTARABINE
61703-305	Cytarabine	CYTARABINE
61703-319	Cytarabine	CYTARABINE
63323-120	Cytarabine	CYTARABINE
67457-452	Cytarabine	Cytarabine
67457-454	Cytarabine	Cytarabine
67457-455	cytarabine	cytarabine
68083-337	Cytarabine	Cytarabine
68083-343	Cytarabine	Cytarabine
71288-108	Cytarabine	Cytarabine
71288-109	Cytarabine	Cytarabine
71288-168	Cytarabine	Cytarabine
71288-169	Cytarabine	Cytarabine