Home NDC 0143-9549-01 Adriamycin
Product NDC 0143-9549
Requested package NDC 0143-9549-01
11-digit product format 001439549
Labeler code 0143
Product ID 0143-9549_7eb88b4b-34e3-4d47-80f4-f17bd690d3b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxorubicin Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA062975
Marketing category ANDA
Marketing start 1996-05-01
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062975-001 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062975-001 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 2 · 41 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 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062975-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1989-03-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9549-01 Adriamycin 5 mL in 1 VIAL INJECTION, SOLUTION 5 10 0143-9549-01 Adriamycin 1 in 1 BOX INJECTION, SOLUTION 1 10 0143-9549-10 Adriamycin 5 mL in 1 VIAL INJECTION, SOLUTION 5 10 0143-9549-10 Adriamycin 10 in 1 BOX INJECTION, SOLUTION 10 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9549 ADRIAMYCIN (DOXORUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 10 Legacy NDC, 4 package rows 20240413_0f153c1e-efce-4276-8273-d9e4c8455d16.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 · 2 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 0143-9549-01 00143954901 1 VIAL in 1 BOX (0143-9549-01) > 5 mL in 1 VIAL 1 vial 1996-05-01 0000-00-00 No No Current