Home NDC 67184-0623 doxorubicin hydrochloride
Product NDC 67184-0623
11-digit product format 671840623
Labeler code 67184
Product ID 67184-0623_c0fef14e-9c64-45d9-b2af-e78848559a25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxorubicin hydrochloride
Dosage form INJECTION, SUSPENSION, LIPOSOMAL
Route INTRAVENOUS
Labeler Qilu Pharmaceutical Co., Ltd.
Application ANDA219881
Marketing category ANDA
Marketing start 2026-02-03
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A219881-001 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 A219881-002 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03
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 2026-10-15 13:18:30 2026-09 A219881-001 DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219881-002 DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219881-001 DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219881-002 DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219881-001 DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219881-002 DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219881-001 DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219881-002 DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219881-001 DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219881-002 DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL / INJECTION AB 2026-02-03 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base doxorubicin hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXORUBICIN HYDROCHLORIDE 2 mg/mL
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67184-0623-1 67184062301 1 VIAL, SINGLE-USE in 1 CARTON (67184-0623-1) / 10 mL in 1 VIAL, SINGLE-USE 2026-02-03 No No Current