Home NDC 16714-001-01 Doxorubicin hydrochloride
Product NDC 16714-001
Requested package NDC 16714-001-01
11-digit product format 167140001
Labeler code 16714
Product ID 16714-001_6756e484-6799-4a06-87b6-225583bd03a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxorubicin hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Northstar RxLLC
Application ANDA203622
Marketing category ANDA
Marketing start 2021-03-22
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 6 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…
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 A203622-001 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 A203622-002 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27
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.
Product history page 1 of 3 · 82 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 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203622-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2014-06-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203622-002 DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION AP 2014-06-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 Marketing end Sample Exclude flag Status 16714-001-01 16714000101 1 VIAL, MULTI-DOSE in 1 CARTON (16714-001-01) > 100 mL in 1 VIAL, MULTI-DOSE 2021-03-22 0000-00-00 No No Current