Home NDC 70121-1218 Doxorubicin Hydrochloride
Product NDC 70121-1218
11-digit product format 701211218
Labeler code 70121
Product ID 70121-1218_f4a01f55-65d7-401f-ac2f-e1511bf3a429
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxorubicin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA208888
Marketing category ANDA
Marketing start 2017-02-17
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 A208888-001 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 A208888-002 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17
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 · 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 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208888-001 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208888-002 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP 2017-02-17 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 1872062 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 70121-1218-1 Doxorubicin Hydrochloride 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 12 70121-1218-1 Doxorubicin Hydrochloride 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 12 70121-1218-7 Doxorubicin Hydrochloride 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-1218 DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC] 12 Current NDC, Legacy NDC, 3 package rows 20240830_d928625e-c1ef-4f25-8d25-764c8c6aab67.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 70121-1218-1 70121121801 1 in 1 CARTON Historical 70121-1218-7 70121121807 10 CARTON in 1 CARTON (70121-1218-7) / 1 VIAL in 1 CARTON (70121-1218-1) / 10 mL in 1 VIAL 10 carton 2017-02-17 0000-00-00 No No Current