Home NDC 57884-3042 Docetaxel
Product NDC 57884-3042
11-digit product format 578843042
Labeler code 57884
Product ID 57884-3042_05e0099c-4a6e-4ca4-e063-6394a90ae073
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Application ANDA207252
Marketing category ANDA
Marketing start 2017-08-09
Substance DOCETAXEL
Active strength 80 mg/4mL
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207252-001 DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 A207252-002 DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 A207252-003 DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09
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 4 · 123 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 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207252-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207252-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207252-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2017-08-09 8072bd15b7f6…
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 80 mg/4mL
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57884-3042-1 Docetaxel 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 21 57884-3042-1 Docetaxel 4 mL in 1 VIAL, GLASS INJECTION, SOLUTION, CONCENTRATE 4 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57884-3042 DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [JIANGSU HENGRUI PHARMACEUTICALS CO., LTD.] 21 Current NDC, Legacy NDC, 2 package rows 20230922_e488100d-6728-4f44-9282-f63a805b8e13.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 Marketing start Marketing end Sample Exclude flag Status 57884-3042-1 57884304201 1 VIAL, GLASS in 1 CARTON (57884-3042-1) / 4 mL in 1 VIAL, GLASS 2017-08-09 0000-00-00 No No Current