Home NDC 16729-267 DOCETAXEL
Product NDC 16729-267
11-digit product format 167290267
Labeler code 16729
Product ID 16729-267_1fbda3cb-1ba1-490d-e063-6294a90a6777
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name docetaxel
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Accord Healthcare Inc.
Application NDA201195
Marketing category NDA
Marketing start 2013-05-30
Substance DOCETAXEL ANHYDROUS
Active strength 20 mg/mL
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201195-001 DOCETAXEL DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 N201195-002 DOCETAXEL DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 N201195-003 DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 N201195-004 DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 N201195-005 DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20
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 6 · 205 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 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 ANHYDROUS 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 699121PHCA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1001405 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16729-267-63 DOCETAXEL 1 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION, CONCENTRATE 1 20 16729-267-63 DOCETAXEL 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 20 16729-267-64 DOCETAXEL 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 20 16729-267-64 DOCETAXEL 4 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION, CONCENTRATE 4 20 16729-267-65 DOCETAXEL 8 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION, CONCENTRATE 8 20 16729-267-65 DOCETAXEL 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-267 DOCETAXEL INJECTION, SOLUTION, CONCENTRATE DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACCORD HEALTHCARE INC.] 20 Current NDC, Legacy NDC, 6 package rows 20240816_f59f7811-70b7-4c44-99f7-4f4fdce3ed22.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 16729-267-63 16729026763 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63) / 1 mL in 1 VIAL, MULTI-DOSE 2013-10-22 0000-00-00 No No Current 16729-267-64 16729026764 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-64) / 4 mL in 1 VIAL, MULTI-DOSE 2013-08-02 0000-00-00 No No Current 16729-267-65 16729026765 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-65) / 8 mL in 1 VIAL, MULTI-DOSE 2013-05-30 0000-00-00 No No Current