Home NDC 67457-781 Docetaxel
Product NDC 67457-781
11-digit product format 674570781
Labeler code 67457
Product ID 67457-781_fea50522-6e4c-4ae0-81ac-53863693cc06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA208137
Marketing category ANDA
Marketing start 2019-06-18
Substance DOCETAXEL
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208137-001 DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208137-001 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 2 · 42 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 2026-08-18 06:07:40 2026-07 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208137-001 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2019-04-01 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 20 mg/mL
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 · 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 67457-781-08 Docetaxel 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 3 67457-781-08 Docetaxel 8 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION, CONCENTRATE 8 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-781 DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240302_a6417655-9448-4886-ba03-f57f36bcbd14.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 67457-781-08 67457078108 1 VIAL, MULTI-DOSE in 1 CARTON (67457-781-08) / 8 mL in 1 VIAL, MULTI-DOSE 2019-06-18 0000-00-00 No No Current