Home NDC 45963-765 Docetaxel
Product NDC 45963-765
11-digit product format 459630765
Labeler code 45963
Product ID 45963-765_0bc8d3b7-f15e-4dbf-b51f-8baaa93b0e61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Actavis Pharma, Inc.
Application NDA203551
Marketing category NDA
Marketing start 2014-09-01
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203551-001 DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 N203551-002 DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 N203551-003 DOCETAXEL DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 N203551-004 DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21
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 5 · 164 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 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203551-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203551-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2013-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203551-003 DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE / INJECTION 2013-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203551-004 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2015-09-21 d06236e962d9…
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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1860480 Internal RxNorm lookup 1860485 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 45963-765-52 Docetaxel 4 mL in 1 VIAL, GLASS INJECTION, SOLUTION, CONCENTRATE 4 52 45963-765-52 Docetaxel 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 52
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOCETAXEL ACTIVE INGREDIENT 15H5577CQD DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] 25 DOCETAXEL ANHYDROUS ACTIVE MOIETY 699121PHCA DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] 25 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] 25 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] 25 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] 25 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] 25
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-765 DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] 52 Current NDC, Legacy NDC, 2 package rows 20240910_2c806400-5fdc-4398-8475-37f700b3191f.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 45963-765-52 45963076552 1 VIAL, GLASS in 1 CARTON (45963-765-52) / 4 mL in 1 VIAL, GLASS 2014-09-01 0000-00-00 No No Current