Home NDC 46708-525 doxorubicin hydrochloride
Product NDC 46708-525
11-digit product format 467080525
Labeler code 46708
Product ID 46708-525_f8e001f5-441c-47cd-86f6-5d5e3de16bc0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxorubicin hydrochloride
Dosage form INJECTION, SUSPENSION, LIPOSOMAL
Route INTRAVENOUS
Labeler Alembic Pharmaceuticals Limited
Application ANDA219199
Marketing category ANDA
Marketing start 2025-06-27
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 A219199-001 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-27 A219199-002 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-27
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.
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 A219199-001 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219199-002 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219199-001 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219199-002 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219199-001 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219199-002 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-27 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219199-001 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219199-002 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-27 a50c72e98297…
Observed Orange Book normalized TE history# 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 1790115 Internal RxNorm lookup 1790127 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 46708-525-25 doxorubicin hydrochloride 25 mL in 1 VIAL, SINGLE-DOSE INJECTION, SUSPENSION, LIPOSOMAL 25 1 46708-525-25 doxorubicin hydrochloride 1 in 1 CARTON INJECTION, SUSPENSION, LIPOSOMAL 1 1
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join doxorubicin hydrochloride DOXORUBICIN HYDROCHLORIDE BluePoint Laboratories 55889588-c5f1-d9bc-e063-6294a90a5791 2026-07-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219199 application number: ANDA219199 doxorubicin hydrochloride DOXORUBICIN HYDROCHLORIDE Dr. Reddy's Laboratories Inc. 0885dddf-727e-4692-92dd-a26c69cc278d 2025-11-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219199 application number: ANDA219199 doxorubicin hydrochloride DOXORUBICIN HYDROCHLORIDE Alembic Pharmaceuticals Inc. c9cb8a8d-944f-4fe1-bfba-c55904a79fda 2025-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219199 application number: ANDA219199 doxorubicin hydrochloride DOXORUBICIN HYDROCHLORIDE Alembic Pharmaceuticals Limited f8e001f5-441c-47cd-86f6-5d5e3de16bc0 2025-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219199 application number: ANDA219199 ndc (product): 46708-525
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 46708-525-25 46708052525 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-525-25) / 25 mL in 1 VIAL, SINGLE-DOSE 2025-06-27 No No Current