Home NDC 70121-1222 Docetaxel
Product NDC 70121-1222
11-digit product format 701211222
Labeler code 70121
Product ID 70121-1222_350853a3-6178-4d83-b5c4-75b3e4c1799d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA209640
Marketing category ANDA
Marketing start 2018-01-19
Substance DOCETAXEL ANHYDROUS
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 A209640-001 DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 A209640-002 DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 A209640-003 DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19
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 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RS 2018-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209640-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209640-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209640-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2018-01-19 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 ANHYDROUS 80 mg/4mL
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 · 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 70121-1222-1 Docetaxel 1 in 1 CARTON INJECTION 1 14 70121-1222-1 Docetaxel 4 mL in 1 VIAL, GLASS INJECTION 4 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-1222 DOCETAXEL INJECTION [AMNEAL PHARMACEUTICALS LLC] 14 Current NDC, Legacy NDC, 2 package rows 20241122_67508df6-b96f-46fa-a792-0afcdfa9810e.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 70121-1222-1 70121122201 1 VIAL, GLASS in 1 CARTON (70121-1222-1) / 4 mL in 1 VIAL, GLASS 2018-01-19 0000-00-00 No No Current