Home NDC 67457-436 Doxorubicin Hydrochloride
Product NDC 67457-436
11-digit product format 674570436
Labeler code 67457
Product ID 67457-436_fa646028-c150-4d9b-80a8-8add851d684d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxorubicin Hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA200170
Marketing category ANDA
Marketing start 2014-02-27
Substance DOXORUBICIN HYDROCHLORIDE
Active strength 2 mg/mL
Pharmacologic classes Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A200170-001 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 A200170-002 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200170-002 AP
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200170-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION 2011-10-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A200170-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2011-10-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Doxorubicin Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXORUBICIN 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 82F2G7BL4E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1790095 Internal RxNorm lookup 1790103 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 67457-436-50 Doxorubicin Hydrochloride 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 6 67457-436-50 Doxorubicin Hydrochloride 25 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 25 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXORUBICIN HYDROCHLORIDE ACTIVE INGREDIENT 82F2G7BL4E DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] 2 DOXORUBICIN ACTIVE MOIETY 80168379AG DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-436 DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240529_5f71f79a-4f14-472d-b982-e28c3ce8f972.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 Units Marketing start Marketing end Sample Exclude flag Status 67457-436-50 67457043650 1 VIAL in 1 CARTON (67457-436-50) / 25 mL in 1 VIAL 1 vial 2014-02-27 0000-00-00 No No Current