DOCIVYX

Product NDC
83831-103
11-digit product format
838310103
Labeler code
83831
Product ID
83831-103_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
160 mg/16mL
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215813-001DOCIVYXDOCETAXEL20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22
N215813-002DOCIVYXDOCETAXEL80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22
N215813-003DOCIVYXDOCETAXEL160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215813-001103987852036-03-14Drug product2023-07-07
N215813-002103987852036-03-14Drug product2023-07-07
N215813-003103987852036-03-14Drug product2023-07-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215813-002DOCIVYX80MG/8ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215813-003DOCIVYX160MG/16ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215813-001DOCIVYX20MG/2ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2022-11-228072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215813-001103987852036-03-14Drug product2023-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215813-002103987852036-03-14Drug product2023-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215813-003103987852036-03-14Drug product2023-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215813-001103987852036-03-14Drug product2023-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215813-002103987852036-03-14Drug product2023-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215813-003103987852036-03-14Drug product2023-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N215813-001103987852036-03-14Drug product2023-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215813-002103987852036-03-14Drug product2023-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215813-003103987852036-03-14Drug product2023-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215813-001103987852036-03-14Drug product2023-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215813-002103987852036-03-14Drug product2023-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215813-003103987852036-03-14Drug product2023-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215813-001103987852036-03-14Drug product2023-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215813-002103987852036-03-14Drug product2023-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215813-003103987852036-03-14Drug product2023-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215813-001103987852036-03-14Drug product2023-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215813-002103987852036-03-14Drug product2023-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215813-003103987852036-03-14Drug product2023-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215813-001103987852036-03-14Drug product2023-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215813-002103987852036-03-14Drug product2023-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215813-003103987852036-03-14Drug product2023-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215813-001103987852036-03-14Drug product2023-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215813-002103987852036-03-14Drug product2023-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215813-003103987852036-03-14Drug product2023-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215813-001103987852036-03-14Drug product2023-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215813-002103987852036-03-14Drug product2023-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215813-003103987852036-03-14Drug product2023-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215813-001103987852036-03-14Drug product2023-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N215813-002103987852036-03-14Drug product2023-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N215813-003103987852036-03-14Drug product2023-07-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215813-001103987852036-03-14Drug product2023-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215813-002103987852036-03-14Drug product2023-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215813-003103987852036-03-14Drug product2023-07-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215813-001103987852036-03-14Drug product2023-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215813-002103987852036-03-14Drug product2023-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215813-003103987852036-03-14Drug product2023-07-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215813-001103987852036-03-14Drug product2023-07-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215813-002103987852036-03-14Drug product2023-07-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215813-003103987852036-03-14Drug product2023-07-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215813-001103987852036-03-14Drug product2023-07-078072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
DOCIVYX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCETAXEL160 mg/16mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15H5577CQDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1860619Internal RxNorm lookup
2679779Internal RxNorm lookup
2679784Internal RxNorm lookup
2679786Internal RxNorm lookup
2679787Internal RxNorm lookup
2679788Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4763744e-360e-4d37-be05-cce4114548cdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be52172d-e80b-4aac-aa81-254100bce67fProduct name920260304
c4fcacbc-a699-410c-905b-642c4d134e72Product name120250616
ad3381c5-7539-4a18-83b7-e7382b118d04Product name120231117
60a22813-7270-4733-af61-30636bce9f0fProduct name420180820
0179c4ba-fb03-4931-875d-b4f1ba528029Product name120160107
9ff92ef8-2da9-4645-bbf8-642e7eb0d754Product name120150812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83831-103-16DOCIVYX1 in 1 CARTONINJECTION, SOLUTION14
83831-103-16DOCIVYX16 mL in 1 VIAL, GLASSINJECTION, SOLUTION164

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83831-103-16ML - Milliliter83831-103b851cefd-5bb3-421d-8177-bece3ed5531512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83831-103DOCIVYX (DOCETAXEL) INJECTION, SOLUTION [AVYXA PHARMA, LLC]3Current NDC, 2 package rows20240706_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCIVYXDOCETAXELAvyxa Pharma, LLC4763744e-360e-4d37-be05-cce4114548cd2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 215813
application number: NDA215813
ndc (product): 83831-103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2679779DOCEtaxel 160 MG in 16 ML InjectionPSN4763744e-360e-4d37-be05-cce4114548cd4
1860619DOCEtaxel 20 MG in 2 ML InjectionPSN4763744e-360e-4d37-be05-cce4114548cd4
2679787DOCEtaxel 80 MG in 8 ML InjectionPSN4763744e-360e-4d37-be05-cce4114548cd4
2679784Docivyx 160 MG in 16 ML InjectionPSN4763744e-360e-4d37-be05-cce4114548cd4
2679786Docivyx 20 MG in 2 ML InjectionPSN4763744e-360e-4d37-be05-cce4114548cd4
2679788Docivyx 80 MG in 8 ML InjectionPSN4763744e-360e-4d37-be05-cce4114548cd4
267978416 ML docetaxel 10 MG/ML Injection [Docivyx]SBD4763744e-360e-4d37-be05-cce4114548cd4
26797862 ML docetaxel 10 MG/ML Injection [Docivyx]SBD4763744e-360e-4d37-be05-cce4114548cd4
26797888 ML docetaxel 10 MG/ML Injection [Docivyx]SBD4763744e-360e-4d37-be05-cce4114548cd4
267977916 ML docetaxel 10 MG/ML InjectionSCD4763744e-360e-4d37-be05-cce4114548cd4
18606192 ML docetaxel 10 MG/ML InjectionSCD4763744e-360e-4d37-be05-cce4114548cd4
26797878 ML docetaxel 10 MG/ML InjectionSCD4763744e-360e-4d37-be05-cce4114548cd4
2679779docetaxel 160 MG per 16 ML InjectionSY4763744e-360e-4d37-be05-cce4114548cd4
1860619docetaxel 20 MG per 2 ML InjectionSY4763744e-360e-4d37-be05-cce4114548cd4
2679787docetaxel 80 MG per 8 ML InjectionSY4763744e-360e-4d37-be05-cce4114548cd4
2679784Docivyx 160 MG per 16 ML InjectionSY4763744e-360e-4d37-be05-cce4114548cd4
2679786Docivyx 20 MG per 2 ML InjectionSY4763744e-360e-4d37-be05-cce4114548cd4
2679788Docivyx 80 MG per 8 ML InjectionSY4763744e-360e-4d37-be05-cce4114548cd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83831-103-16838310103161 VIAL, GLASS in 1 CARTON (83831-103-16) / 16 mL in 1 VIAL, GLASS2024-05-09NoNoCurrent