NDC 63323-151

Epirubicin Hydrochloride

Epirubicin Hydrochloride

Epirubicin Hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Epirubicin Hydrochloride.

• Product ID: 63323-151_873ef01e-d426-42c1-8062-260253255b09
• NDC: 63323-151
• Product Type: Human Prescription Drug
• Proprietary Name: Epirubicin Hydrochloride
• Generic Name: Epirubicin Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-07-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065411
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: EPIRUBICIN HYDROCHLORIDE
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63323-151-00

1 VIAL, SINGLE-DOSE in 1 CARTON (63323-151-00) > 100 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-151-25 [63323015125]

Epirubicin Hydrochloride INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065411
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-07-31
• Marketing End Date: 2013-11-30

NDC 63323-151-00 [63323015100]

Epirubicin Hydrochloride INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065411
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2007-12-26
• Marketing End Date: 2013-11-30

Drug Details

Active Ingredients

Ingredient	Strength
EPIRUBICIN HYDROCHLORIDE	2 mg/mL

OpenFDA Data

• SPL SET ID: 3b433650-0dca-4714-bb72-341036d3972e
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 22966TX7J5
• RxNorm Concept Unique ID - RxCUI:
  • 1732186
• UPC Code:
  • 0363323151256
  • 0363323151003

Pharmacological Class

• Anthracycline Topoisomerase Inhibitor [EPC]
• Anthracyclines [CS]
• Topoisomerase Inhibitors [MoA]

NDC Crossover Matching brand name "Epirubicin Hydrochloride" or generic name "Epirubicin Hydrochloride"

NDC	Brand Name	Generic Name
0115-1675	Epirubicin Hydrochloride	Epirubicin Hydrochloride
0143-9202	Epirubicin Hydrochloride	Epirubicin Hydrochloride
0143-9203	Epirubicin Hydrochloride	Epirubicin Hydrochloride
25021-203	Epirubicin Hydrochloride	epirubicin hydrochloride
45963-608	Epirubicin Hydrochloride	Epirubicin Hydrochloride
59923-701	EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE
63323-151	Epirubicin Hydrochloride	epirubicin hydrochloride
66758-042	Epirubicin Hydrochloride	Epirubicin Hydrochloride
0009-5091	Ellence	epirubicin hydrochloride
0009-5093	Ellence	epirubicin hydrochloride