Home NDC 0069-4031-01 Doxorubicin Hydrochloride
Product NDC 0069-4031
Requested package NDC 0069-4031-01
11-digit product format 000694031
Labeler code 0069
Product ID 0069-4031_d31d7f58-66d0-4826-b6b5-5914c031965f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxorubicin Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA050629
Marketing category NDA
Marketing start 2025-03-31
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N050629-001 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 N050629-002 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 N050629-003 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28
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 · 123 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 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050629-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP RLD, RS 1988-05-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050629-003 DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE / INJECTION RLD 2011-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050629-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 1987-12-23 8072bd15b7f6…
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 1790097 Internal RxNorm lookup 1790099 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 0069-4031-12 Doxorubicin Hydrochloride 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 1 0069-4031-12 Doxorubicin Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-4031 DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 1 Current NDC, Legacy NDC, 2 package rows 20250402_d31d7f58-66d0-4826-b6b5-5914c031965f.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 · 3 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 0069-4031-01 00069403101 1 VIAL, SINGLE-DOSE in 1 PACKAGE (0069-4031-01) > 10 mL in 1 VIAL, SINGLE-DOSE 2013-03-05 0000-00-00 No No Current