Home NDC 43598-258 Docetaxel
Product NDC 43598-258
11-digit product format 435980258
Labeler code 43598
Product ID 43598-258_b06584c8-f4fd-46dd-a1f2-0e3672b24938
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA204193
Marketing category ANDA
Marketing start 2014-11-10
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204193-001 DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 A204193-002 DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204193-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204193-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2014-11-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 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 43598-258-11 Docetaxel 1 mL in 1 VIAL, GLASS INJECTION, SOLUTION 1 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-258 DOCETAXEL INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.] 17 Current NDC, Legacy NDC, 1 package rows 20211203_a630937b-8369-74ad-b68a-f940eb16ff0f.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43598-258-11 43598025811 1 mL in 1 VIAL, GLASS (43598-258-11) 1 ml 2014-11-10 0000-00-00 No No Current