Home NDC 0009-5091-01 Ellence
Product NDC 0009-5091
Requested package NDC 0009-5091-01
11-digit product format 000095091
Labeler code 0009
Product ID 0009-5091_ec48409f-8260-42aa-89bc-222c2db99ea3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name epirubicin hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Pharmacia & Upjohn Company LLC
Application NDA050778
Marketing category NDA
Marketing start 1999-09-15
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 2027-12-31
Current FDA listing Yes 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 N050778-001 ELLENCE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 N050778-002 ELLENCE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15
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 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ellence
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPIRUBICIN HYDROCHLORIDE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 22966TX7J5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1732182 Internal RxNorm lookup 1732183 Internal RxNorm lookup 1732186 Internal RxNorm lookup 1732187 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0009-5091-01 Ellence 25 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 25 25 0009-5091-01 Ellence 1 in 1 CARTON INJECTION, SOLUTION 1 25 0009-5091-25 Ellence 1 in 1 CARTON INJECTION, SOLUTION 1 25 0009-5091-25 Ellence 25 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 25 25
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-5091 ELLENCE (EPIRUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] 22 Current NDC, Legacy NDC, 4 package rows 20250326_0a03c798-a652-4895-b29c-3b521a89ba42.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0009-5091-01 00009509101 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-01) > 25 mL in 1 VIAL, SINGLE-DOSE 1999-09-15 0000-00-00 No No Current