Home NDC 0075-8003 TAXOTERE
Product NDC 0075-8003
11-digit product format 000758003
Labeler code 0075
Product ID 0075-8003_efb93f68-fb30-4836-bcb2-0b9f97f5be58
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Sanofi-Aventis U.S. LLC
Application NDA020449
Marketing category NDA
Marketing start 2010-08-02
Marketing end 2020-03-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0075-8003-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0075-8003-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0075-8003-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0075-8003-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0075-8003-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0075-8003-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0075-8003-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0075-8003-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0075-8003-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0075-8003-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0075-8003-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0075-8003-01 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 N020449-001 TAXOTERE DOCETAXEL 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 N020449-003 TAXOTERE DOCETAXEL 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2010-08-03 N020449-004 TAXOTERE DOCETAXEL 80MG/4ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2010-08-02 N020449-005 TAXOTERE DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020449-005 AP
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 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 115 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Docetaxel ACTIVE INGREDIENT 15H5577CQD TAXOTERE (DOCETAXEL) INJECTION, SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC] 13 Docetaxel Anhydrous ACTIVE MOIETY 699121PHCA TAXOTERE (DOCETAXEL) INJECTION, SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC] 13 alcohol INACTIVE INGREDIENT 3K9958V90M TAXOTERE (DOCETAXEL) INJECTION, SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC] 13 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H TAXOTERE (DOCETAXEL) INJECTION, SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC] 13
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 Sanofi-Aventis U.S. LLC dd0ca36d-1f54-4568-8d19-a7152addcd52 2024-12-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020449 application number: NDA020449