Home NDC 0955-1022 Docetaxel
Product NDC 0955-1022
11-digit product format 009551022
Labeler code 0955
Product ID 0955-1022_7c9667b2-3981-4256-a6a5-0c862549f837
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 AUTHORIZED GENERIC
Marketing start 2016-10-23
Substance DOCETAXEL
Active strength 160 mg/8mL
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 4 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 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 0955-1022-08 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 0955-1022-08 367a005e9d99…383a685ebd0f…
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date N020449-001 TAXOTERE DOCETAXEL 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 N020449-003 TAXOTERE DOCETAXEL 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2010-08-03 N020449-004 TAXOTERE DOCETAXEL 80MG/4ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2010-08-02 N020449-005 TAXOTERE DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD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.
Additional Listing Data#
Finished product Yes
Brand name base Docetaxel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCETAXEL 160 mg/8mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15H5577CQD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1860480 Internal RxNorm lookup 1860485 Internal RxNorm lookup 1861411 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0955-1022-08 Docetaxel 8 mL in 1 VIAL, GLASS INJECTION, SOLUTION, CONCENTRATE 8 30 0955-1022-08 Docetaxel 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Docetaxel ACTIVE INGREDIENT 15H5577CQD DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.] 11 Docetaxel Anhydrous ACTIVE MOIETY 699121PHCA DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.] 11 alcohol INACTIVE INGREDIENT 3K9958V90M DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.] 11 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0955-1022 DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC] 30 Current NDC, Legacy NDC, 2 package rows 20241210_dd0ca36d-1f54-4568-8d19-a7152addcd52.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0955-1022-08 00955102208 1 VIAL, GLASS in 1 CARTON (0955-1022-08) / 8 mL in 1 VIAL, GLASS 2016-10-23 0000-00-00 No No Current