Home NDC 45963-790-56 Docetaxel
Product NDC 45963-790
Requested package NDC 45963-790-56
11-digit product format 459630790
Labeler code 45963
Product ID 45963-790_5a6c204e-5b3b-40fc-b007-a4d21ae6c406
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Actavis Pharma, Inc.
Application NDA203551
Marketing category NDA
Marketing start 2015-10-13
Marketing end 2021-02-28
Substance DOCETAXEL
Active strength 20 mg/mL
Pharmacologic classes Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 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…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203551-001 DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 N203551-002 DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 N203551-003 DOCETAXEL DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 N203551-004 DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 5 · 164 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 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Docetaxel DOCETAXEL Actavis Pharma, Inc. 2c806400-5fdc-4398-8475-37f700b3191f 2024-08-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 203551 application number: NDA203551
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 45963-790-56 45963079056 1 VIAL, GLASS in 1 CARTON (45963-790-56) > 8 mL in 1 VIAL, GLASS 2015-10-13 2021-02-28 No No Current