Home NDC 83831-101 DOCIVYX
Product NDC 83831-101
11-digit product format 838310101
Labeler code 83831
Product ID 83831-101_6d914dea-626d-4402-8fce-29760fd0e34f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name docetaxel
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Avyxa Pharma, LLC
Application NDA215813
Marketing category NDA
Marketing start 2024-05-09
Substance DOCETAXEL
Active strength 20 mg/2mL
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 N215813-001 DOCIVYX DOCETAXEL 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 N215813-002 DOCIVYX DOCETAXEL 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 N215813-003 DOCIVYX DOCETAXEL 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215813-001 10398785 2036-03-14 Drug product 2023-07-07 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 N215813-003 10398785 2036-03-14 Drug product 2023-07-07
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 · 72 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 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215813-002 DOCIVYX 80MG/8ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215813-003 DOCIVYX 160MG/16ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215813-001 DOCIVYX 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-11-22 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 2 · 63 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215813-002 10398785 2036-03-14 Drug product 2023-07-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215813-003 10398785 2036-03-14 Drug product 2023-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215813-001 10398785 2036-03-14 Drug product 2023-07-07 8072bd15b7f6…
Additional Listing Data#
Finished product Yes
Brand name base DOCIVYX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCETAXEL 20 mg/2mL
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1860619 Internal RxNorm lookup 2679779 Internal RxNorm lookup 2679784 Internal RxNorm lookup 2679786 Internal RxNorm lookup 2679787 Internal RxNorm lookup 2679788 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 83831-101-02 DOCIVYX 1 in 1 CARTON INJECTION, SOLUTION 1 4 83831-101-02 DOCIVYX 2 mL in 1 VIAL, GLASS INJECTION, SOLUTION 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83831-101 DOCIVYX (DOCETAXEL) INJECTION, SOLUTION [AVYXA PHARMA, LLC] 3 Current NDC, 2 package rows 20240706_4763744e-360e-4d37-be05-cce4114548cd.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 Sample Exclude flag Status 83831-101-02 83831010102 1 VIAL, GLASS in 1 CARTON (83831-101-02) / 2 mL in 1 VIAL, GLASS 2024-05-09 No No Current