Home NDC 0409-1732 Docetaxel
Product NDC 0409-1732
11-digit product format 004091732
Labeler code 0409
Product ID 0409-1732_5b12d54f-e7fd-4369-afb3-431f6f08ec76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOCETAXEL ANHYDROUS
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA022234
Marketing category NDA
Marketing start 2021-06-28
Substance DOCETAXEL ANHYDROUS
Active strength 10 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 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022234-001 DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 N022234-002 DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 N022234-003 DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 N022234-004 DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 N022234-005 DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 N022234-006 DOCETAXEL DOCETAXEL 120MG/6ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 N022234-007 DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION RLD 2017-01-24
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 8 · 287 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 N022234-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022234-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022234-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022234-004 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022234-005 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022234-006 DOCETAXEL 120MG/6ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022234-007 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION RLD 2017-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022234-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022234-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022234-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022234-004 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022234-005 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022234-006 DOCETAXEL 120MG/6ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022234-007 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION RLD 2017-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022234-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022234-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022234-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022234-004 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022234-005 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022234-006 DOCETAXEL 120MG/6ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022234-007 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION RLD 2017-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022234-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022234-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022234-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022234-004 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022234-005 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022234-006 DOCETAXEL 120MG/6ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022234-007 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION RLD 2017-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022234-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022234-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022234-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022234-004 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022234-005 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022234-006 DOCETAXEL 120MG/6ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022234-007 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION RLD 2017-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022234-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022234-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022234-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP RLD, RS 2011-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022234-004 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022234-005 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2016-06-23 03ed91905a0d…
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 10 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 1093280 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 0409-1732-01 Docetaxel 1 in 1 CARTON INJECTION, SOLUTION 1 7 0409-1732-01 Docetaxel 16 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 16 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1732 DOCETAXEL (DOCETAXEL ANHYDROUS) INJECTION, SOLUTION [HOSPIRA, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20250123_644c5035-20d2-4686-beaa-bef08e99051c.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Docetaxel DOCETAXEL Hospira, Inc. 6b9999bb-869e-4d25-838c-23c3ab280044 2025-01-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022234 application number: NDA022234 Docetaxel DOCETAXEL ANHYDROUS Hospira, Inc. 644c5035-20d2-4686-beaa-bef08e99051c 2025-01-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022234 application number: NDA022234 ndc (product): 0409-1732 Docetaxel DOCETAXEL ANHYDROUS Hospira, Inc. 00c61d11-d6b7-4618-b6f6-2592dbcc8af7 2025-01-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022234 application number: NDA022234 Docetaxel DOCETAXEL Hospira, Inc. 3104aab1-cd6e-4ad2-8e0a-286a0c5d1940 2024-09-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022234 application number: NDA022234 Docetaxel DOCETAXEL ANHYDROUS Hospira, Inc. a0ec4bcc-93ea-4c41-a4b6-95ec19491807 2024-08-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022234 application number: NDA022234
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 0409-1732-01 00409173201 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1732-01) / 16 mL in 1 VIAL, MULTI-DOSE 2021-06-28 0000-00-00 No No Current