NDC 0115-1675

Epirubicin Hydrochloride

Epirubicin Hydrochloride

Epirubicin Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Impax Generics. The primary component is Epirubicin Hydrochloride.

• Product ID: 0115-1675_4f954c6a-221b-494c-aea7-1a8c1b65e424
• NDC: 0115-1675
• Product Type: Human Prescription Drug
• Proprietary Name: Epirubicin Hydrochloride
• Generic Name: Epirubicin Hydrochloride
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-09-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065445
• Labeler Name: Impax Generics
• 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 0115-1675-73

1 VIAL, SINGLE-USE in 1 CARTON (0115-1675-73) > 100 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2016-09-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0115-1675-72 [00115167572]

Epirubicin Hydrochloride INJECTION

• Marketing Category: ANDA
• Application Number: ANDA065445
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-09-21
• Marketing End Date: 2019-04-30

NDC 0115-1675-73 [00115167573]

Epirubicin Hydrochloride INJECTION

• Marketing Category: ANDA
• Application Number: ANDA065445
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-09-21
• Marketing End Date: 2018-10-31

Drug Details

Active Ingredients

Ingredient	Strength
EPIRUBICIN HYDROCHLORIDE	2 mg/mL

OpenFDA Data

• SPL SET ID: 5db7306e-2ec4-4368-86f1-135c4bb5b58a
• Manufacturer:
  • Impax Generics
• UNII:
  • 22966TX7J5
• RxNorm Concept Unique ID - RxCUI:
  • 1732182
  • 1732186

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