Home NDC 23155-905 Docetaxel
Product NDC 23155-905
11-digit product format 231550905
Labeler code 23155
Product ID 23155-905_459836aa-017b-4ba5-a69d-d16824f719fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION
Route INTRAVENOUS
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA216677
Marketing category ANDA
Marketing start 2024-12-15
Substance DOCETAXEL
Active strength 160 mg/8mL
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216677-001 DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 A216677-002 DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 A216677-003 DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26
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.
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 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Docetaxel
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 23155-905-31 Docetaxel 1 in 1 CARTON INJECTION 1 2 23155-905-31 Docetaxel 8 mL in 1 VIAL INJECTION 8 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-905 DOCETAXEL INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20241218_81686d37-a13f-46e2-b439-a84eb1433634.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Docetaxel DOCETAXEL Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 81686d37-a13f-46e2-b439-a84eb1433634 2026-03-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216677 application number: ANDA216677 ndc (product): 23155-905
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 23155-905-31 23155090531 1 VIAL in 1 CARTON (23155-905-31) / 8 mL in 1 VIAL 1 vial 2024-12-15 No No Current