Home NDC 63323-101 Doxorubicin Hydrochloride
Product NDC 63323-101
11-digit product format 633230101
Labeler code 63323
Product ID 63323-101_89998b96-8ca7-4eb1-98a4-e533420d0e72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXORUBICIN HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA063277
Marketing category ANDA
Marketing start 2000-06-14
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A063277-001 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A063277-001 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 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A063277-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 1995-10-26 cb3db0bc1861…
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191138 Internal RxNorm lookup 1790097 Internal RxNorm lookup 1790099 Internal RxNorm lookup 1790100 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 63323-101-61 Doxorubicin Hydrochloride 100 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 100 5 63323-101-61 Doxorubicin Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXORUBICIN HYDROCHLORIDE ACTIVE INGREDIENT 82F2G7BL4E DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 DOXORUBICIN ACTIVE MOIETY 80168379AG DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-101 DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241018_e0349f98-42fa-4003-b6d8-a1db1401b0ef.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 63323-101-61 63323010161 1 VIAL, MULTI-DOSE in 1 CARTON (63323-101-61) / 100 mL in 1 VIAL, MULTI-DOSE 2000-06-14 0000-00-00 No No Current