DOXORUBICIN HYDROCHLORIDE

Product NDC
49315-008
11-digit product format
493150008
Labeler code
49315
Product ID
49315-008_2c0f5abf-ca66-445c-9a35-e39b2111911e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxorubicin hydrochloride
Dosage form
INJECTABLE, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Zydus Lifesciences Limited
Application
ANDA212299
Marketing category
ANDA
Marketing start
2020-09-14
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10
A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212299-001AB
A212299-002AB

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212299-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212299-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212299-001DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212299-002DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212299-001DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212299-002DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212299-001DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212299-002DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-104b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212299-001DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212299-002DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212299-001DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10782e0a99824c…
2021-12-28 21:50 UTC2021-12A212299-002DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212299-001DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-1087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212299-002DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2020-09-1087673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212299-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212299-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212299-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212299-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212299-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212299-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212299-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212299-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212299-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212299-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212299-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212299-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212299-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212299-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212299-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212299-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212299-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212299-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212299-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212299-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212299-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212299-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212299-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212299-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212299-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212299-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212299-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212299-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212299-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212299-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212299-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212299-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212299-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212299-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212299-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212299-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212299-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A212299-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212299-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212299-002AB187673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
DOXORUBICIN HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXORUBICIN HYDROCHLORIDE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82F2G7BL4EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1790115Internal RxNorm lookup
1790127Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bad467d4-7e27-4eda-b4d3-854460f0adabAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ee64805-1a32-49b4-a119-9376fc9e6633Product name520250305
750deab0-bb49-36cc-d493-bfaec857a32eProduct name520190807
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49315-008-03DOXORUBICIN HYDROCHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTABLE, LIPOSOMAL102
49315-008-03DOXORUBICIN HYDROCHLORIDE1 in 1 CARTONINJECTABLE, LIPOSOMAL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49315-008DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 2 package rows20221107_bad467d4-7e27-4eda-b4d3-854460f0adab.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 HYDROCHLORIDEBluePoint Laboratoriesada390ce-50ea-4de5-be58-5b03caf33c232026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212299
application number: ANDA212299
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.15a84bd6-b565-4722-bb92-e4c919620a902026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212299
application number: ANDA212299
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEZydus Lifesciences Limitedbad467d4-7e27-4eda-b4d3-854460f0adab2022-11-01Exact identifier
application applno (ANDA): 212299
application number: ANDA212299
ndc (product): 49315-008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNbad467d4-7e27-4eda-b4d3-854460f0adab2
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSNbad467d4-7e27-4eda-b4d3-854460f0adab2
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDbad467d4-7e27-4eda-b4d3-854460f0adab2
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDbad467d4-7e27-4eda-b4d3-854460f0adab2
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYbad467d4-7e27-4eda-b4d3-854460f0adab2
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSYbad467d4-7e27-4eda-b4d3-854460f0adab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49315-008-03493150008031 VIAL, SINGLE-DOSE in 1 CARTON (49315-008-03) / 10 mL in 1 VIAL, SINGLE-DOSE2020-09-140000-00-00NoNoCurrent