Home NDC 45963-733 Doxorubicin hydrochloride
Product NDC 45963-733
11-digit product format 459630733
Labeler code 45963
Product ID 45963-733_2ad7c99b-8cea-4e22-826f-9e49c90605b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxorubicin hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Actavis Pharma, Inc.
Application ANDA203622
Marketing category ANDA
Marketing start 2014-11-01
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 A203622-001 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 A203622-002 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27
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 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 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 · 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 45963-733-55 Doxorubicin hydrochloride 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 16 45963-733-55 Doxorubicin hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 16 45963-733-57 Doxorubicin hydrochloride 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 16 45963-733-57 Doxorubicin hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 16 45963-733-60 Doxorubicin hydrochloride 100 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 100 16 45963-733-60 Doxorubicin hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 16 45963-733-68 Doxorubicin hydrochloride 25 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 25 16 45963-733-68 Doxorubicin hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXORUBICIN HYDROCHLORIDE ACTIVE INGREDIENT 82F2G7BL4E DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 4 DOXORUBICIN ACTIVE MOIETY 80168379AG DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-733 DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 16 Current NDC, Legacy NDC, 8 package rows 20241109_33ddfdb1-b4bc-464d-a186-49c4b156279f.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 45963-733-55 45963073355 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-55) / 5 mL in 1 VIAL, SINGLE-DOSE 2014-11-01 0000-00-00 No No Current 45963-733-57 45963073357 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-57) / 10 mL in 1 VIAL, SINGLE-DOSE 2014-11-01 0000-00-00 No No Current 45963-733-60 45963073360 1 VIAL, MULTI-DOSE in 1 CARTON (45963-733-60) / 100 mL in 1 VIAL, MULTI-DOSE 2014-11-01 0000-00-00 No No Current 45963-733-68 45963073368 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-68) / 25 mL in 1 VIAL, SINGLE-DOSE 2014-11-01 0000-00-00 No No Current