25021-223 NDC - CYTARABINE

Drug Information

Product NDC: 25021-223
Proprietary Name: cytarabine
Non Proprietary Name: cytarabine
Active Ingredient(s): 100 mg/mL CYTARABINE
Administration Route(s): INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Dosage Form(s): INJECTION, SOLUTION
Pharmacy Class(es): Nucleic Acid Synthesis Inhibitors [MoA]; Nucleoside Metabolic Inhibitor [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Sagent Pharmaceuticals
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA211938
Marketing Category:	ANDA
Start Marketing Date:	6/1/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	25021-223-20	1 VIAL in 1 CARTON (25021-223-20) / 20 mL in 1 VIAL	ML

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	25021-223	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	The translation of the dosage form Code submitted by the firm.
PROPRIETARY NAME	cytarabine	The translation of the route code submitted by the firm, indicating route of administration.
NON PROPRIETARY NAME	cytarabine	This is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAME	INJECTION, SOLUTION	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ROUTE NAME	INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
START MARKETING DATE	6/1/2023	Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAME	ANDA	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
APPLICATION NUMBER	ANDA211938	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	Sagent Pharmaceuticals	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	CYTARABINE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	100
ACTIVE INGRED UNIT	mg/mL
PHARM CLASSES	Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]

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This page was last updated on: 12/19/2025

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