Home NDC 45963-608 Epirubicin Hydrochloride
Product NDC 45963-608
11-digit product format 459630608
Labeler code 45963
Product ID 45963-608_9688d8b5-3a1b-4802-bdab-6ff651741400
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Epirubicin Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Actavis Pharma, Inc.
Application ANDA065445
Marketing category ANDA
Marketing start 2011-11-28
Marketing end 2021-06-30
Substance EPIRUBICIN HYDROCHLORIDE
Active strength 2 mg/mL
Pharmacologic classes Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065445-001 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 A065445-002 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 A065445-003 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065445-002 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065445-003 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065445-001 EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE / INJECTION 2008-09-18 301d65b070ca…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 45963-608-68 45963060868 1 VIAL, SINGLE-USE in 1 CARTON (45963-608-68) > 25 mL in 1 VIAL, SINGLE-USE 2011-11-28 2021-06-30 No No Current