Home NDC 0143-9092 Doxorubicin Hydrochloride
Product NDC 0143-9092
11-digit product format 001439092
Labeler code 0143
Product ID 0143-9092_3b0d5f19-5eab-4729-8fbf-3b988cbc6d04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxorubicin Hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA062921
Marketing category ANDA
Marketing start 2018-01-19
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 42 .
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 A062921-001 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 A062921-002 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 A062921-003 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17
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 4 · 126 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 2026-08-18 06:07:40 2026-07 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062921-002 DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062921-003 DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE / INJECTION AP RS 1989-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062921-001 DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE / INJECTION RS 1989-03-17 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 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 0143-9092-01 Doxorubicin Hydrochloride 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 3 0143-9092-01 Doxorubicin Hydrochloride 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9092 DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240427_f62aa88d-1e25-4049-87ec-99d42edd1d31.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 0143-9092-01 00143909201 1 VIAL in 1 BOX (0143-9092-01) / 5 mL in 1 VIAL 1 vial 2018-01-19 0000-00-00 No No Current