Doxorubicin Hydrochloride

Product NDC
0069-4026
11-digit product format
000694026
Labeler code
0069
Product ID
0069-4026_7de0221b-3903-4ec6-a5ba-9ede8e8a45a6
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
2014-03-17
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0069-4026DDiscontinued by firm2026-08-03
excluded packagepackage0069-40260069-4026-25DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050629-001DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-23
N050629-002DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-03
N050629-003DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N050629-001AP
N050629-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050629-002DOXORUBICIN HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPRLD, RS1988-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050629-003DOXORUBICIN HYDROCHLORIDE150MG/75MLINJECTABLE / INJECTIONRLD2011-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050629-001DOXORUBICIN HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS1987-12-238072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050629-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050629-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050629-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050629-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050629-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050629-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050629-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050629-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050629-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050629-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050629-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050629-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050629-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050629-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050629-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050629-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050629-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050629-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050629-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050629-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050629-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050629-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050629-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050629-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050629-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050629-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050629-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050629-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050629-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050629-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050629-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050629-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050629-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050629-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050629-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050629-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050629-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050629-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050629-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N050629-002AP1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ee64805-1a32-49b4-a119-9376fc9e6633Product name520250305
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
750deab0-bb49-36cc-d493-bfaec857a32eProduct name520190807
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-4026-25Doxorubicin Hydrochloride1 in 1 CARTONINJECTION, SOLUTION114
0069-4026-25Doxorubicin Hydrochloride25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-4026-25ML - Milliliter0069-402643c552a6-1493-4414-af01-d49531768ab112014-04-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-4026DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]13Legacy NDC, 2 package rows20241113_00634b2b-4e48-4178-8877-28582af894ad.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Inc1fd148fb-0fbc-4b6f-b790-23546fb46a712026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050629
application number: NDA050629
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Inc00634b2b-4e48-4178-8877-28582af894ad2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050629
application number: NDA050629
ndc (product): 0069-4026
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Incd31d7f58-66d0-4826-b6b5-5914c031965f2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050629
application number: NDA050629

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790097DOXOrubicin HCl 10 MG in 5 mL InjectionPSN00634b2b-4e48-4178-8877-28582af894ad14
1191138DOXOrubicin HCl 2 MG/ML Injectable SolutionPSN00634b2b-4e48-4178-8877-28582af894ad14
1790099DOXOrubicin HCl 20 MG in 10 ML InjectionPSN00634b2b-4e48-4178-8877-28582af894ad14
1790100DOXOrubicin HCl 50 MG in 25 ML InjectionPSN00634b2b-4e48-4178-8877-28582af894ad14
179009910 ML doxorubicin hydrochloride 2 MG/ML InjectionSCD00634b2b-4e48-4178-8877-28582af894ad14
179010025 ML doxorubicin hydrochloride 2 MG/ML InjectionSCD00634b2b-4e48-4178-8877-28582af894ad14
17900975 ML doxorubicin hydrochloride 2 MG/ML InjectionSCD00634b2b-4e48-4178-8877-28582af894ad14
1191138doxorubicin hydrochloride 2 MG/ML Injectable SolutionSCD00634b2b-4e48-4178-8877-28582af894ad14
1790097doxorubicin hydrochloride 10 MG per 5 ML InjectionSY00634b2b-4e48-4178-8877-28582af894ad14
1790099doxorubicin hydrochloride 20 MG per 10 ML InjectionSY00634b2b-4e48-4178-8877-28582af894ad14
1790100doxorubicin hydrochloride 50 MG per 25 ML InjectionSY00634b2b-4e48-4178-8877-28582af894ad14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-4026-25000694026251 VIAL, SINGLE-DOSE in 1 CARTON (0069-4026-25) > 25 mL in 1 VIAL, SINGLE-DOSE2014-03-170000-00-00NoNoCurrent