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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45963-79045963-790-56DDiscontinued by firm2026-08-11

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203551-001DOCETAXELDOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12
N203551-002DOCETAXELDOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12
N203551-003DOCETAXELDOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-12
N203551-004DOCETAXELDOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N203551-001AP
N203551-002AP
N203551-004AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203551-001DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203551-002DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203551-003DOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203551-004DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203551-001DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203551-002DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203551-003DOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203551-004DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N203551-001DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203551-002DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203551-003DOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203551-004DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203551-001DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203551-002DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203551-003DOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203551-004DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203551-001DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203551-002DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203551-003DOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203551-004DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203551-001DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203551-002DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203551-003DOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203551-004DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203551-001DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203551-002DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203551-003DOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203551-004DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203551-001DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203551-002DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203551-003DOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203551-004DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203551-001DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203551-002DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203551-003DOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203551-004DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203551-001DOCETAXEL20MG/ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N203551-002DOCETAXEL80MG/4ML (20MG/ML)INJECTABLE / INJECTIONAP2013-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N203551-003DOCETAXEL140MG/7ML (20MG/ML)INJECTABLE / INJECTION2013-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N203551-004DOCETAXEL160MG/8ML (20MG/ML)INJECTABLE / INJECTIONAP2015-09-21d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N203551-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203551-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203551-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203551-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203551-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203551-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N203551-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203551-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203551-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203551-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203551-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203551-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203551-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203551-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203551-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203551-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203551-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203551-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203551-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203551-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203551-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203551-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203551-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203551-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203551-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203551-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203551-004AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203551-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N203551-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N203551-004AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203551-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203551-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203551-004AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203551-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203551-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203551-004AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203551-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203551-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203551-004AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203551-001AP18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-790-56ML - Milliliter45963-790f78ae585-ee6f-47f3-ba09-0ab32b69f57212015-12-02

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DocetaxelDOCETAXELActavis Pharma, Inc.2c806400-5fdc-4398-8475-37f700b3191f2024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 203551
application number: NDA203551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45963-790-56459630790561 VIAL, GLASS in 1 CARTON (45963-790-56) > 8 mL in 1 VIAL, GLASS2015-10-132021-02-28NoNoCurrent