Home NDC 0143-9202 Epirubicin Hydrochloride
Product NDC 0143-9202
11-digit product format 001439202
Labeler code 0143
Product ID 0143-9202_a854383a-1d91-456c-baae-2e4011faf1a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Epirubicin Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA065289
Marketing category ANDA
Marketing start 2007-08-07
Marketing end 0000-00-00
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 2020-12-31
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0143-9202-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0143-9202-01 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065289-001 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 A065289-002 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 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 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065289-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065289-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-06-27 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9202 EPIRUBICIN HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 6 Legacy NDC 20240724_a24ff5f2-0a9a-4222-9135-1d4094ddd2e0.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0143-9202-01 00143920201 1 VIAL in 1 BOX (0143-9202-01) > 25 mL in 1 VIAL 1 vial 2007-08-07 0000-00-00 No No Current