Frindovyx

Product NDC
83831-119
11-digit product format
838310119
Labeler code
83831
Product ID
83831-119_e3e444b2-9344-4cc2-b35a-370073a747d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
AVYXA Pharma, LLC
Application
NDA210852
Marketing category
NDA
Marketing start
2025-03-19
Substance
CYCLOPHOSPHAMIDE
Active strength
500 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N210852-001FRINDOVYXCYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07
N210852-002FRINDOVYXCYCLOPHOSPHAMIDE1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07
N210852-003FRINDOVYXCYCLOPHOSPHAMIDE2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210852-001108499162035-07-13Drug product2023-06-27
N210852-001113829232035-12-01Drug product2023-06-27
N210852-002108499162035-07-13Drug product2023-06-27
N210852-002113829232035-12-01Drug product2023-06-27
N210852-003108499162035-07-13Drug product2023-06-27
N210852-003113829232035-12-01Drug product2023-06-27

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 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N210852-001FRINDOVYX500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0784e616aacf4f…
2026-09-14 22:38:342026-08N210852-002FRINDOVYX1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0784e616aacf4f…
2026-09-14 22:38:342026-08N210852-003FRINDOVYX2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0784e616aacf4f…
2026-08-18 06:07:402026-07N210852-001FRINDOVYX500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07caaa826d4ba7…
2026-08-18 06:07:402026-07N210852-002FRINDOVYX1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07caaa826d4ba7…
2026-08-18 06:07:402026-07N210852-003FRINDOVYX2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210852-001FRINDOVYX500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210852-002FRINDOVYX1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210852-003FRINDOVYX2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210852-001FRINDOVYX500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210852-002FRINDOVYX1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210852-003FRINDOVYX2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N210852-001CYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210852-002CYCLOPHOSPHAMIDE1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210852-003CYCLOPHOSPHAMIDE2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210852-001CYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210852-002CYCLOPHOSPHAMIDE1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210852-003CYCLOPHOSPHAMIDE2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210852-001CYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210852-002CYCLOPHOSPHAMIDE1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210852-003CYCLOPHOSPHAMIDE2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210852-001CYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210852-002CYCLOPHOSPHAMIDE1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210852-003CYCLOPHOSPHAMIDE2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210852-001CYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210852-002CYCLOPHOSPHAMIDE1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210852-003CYCLOPHOSPHAMIDE2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210852-001CYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210852-002CYCLOPHOSPHAMIDE1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210852-003CYCLOPHOSPHAMIDE2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210852-001CYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210852-002CYCLOPHOSPHAMIDE1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210852-003CYCLOPHOSPHAMIDE2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210852-001CYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N210852-002CYCLOPHOSPHAMIDE1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N210852-003CYCLOPHOSPHAMIDE2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210852-001CYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210852-002CYCLOPHOSPHAMIDE1GM/2ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210852-003CYCLOPHOSPHAMIDE2GM/4ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210852-001CYCLOPHOSPHAMIDE500MG/ML (500MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-06-07301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 4 · 138 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N210852-001108499162035-07-13Drug product2023-06-2784e616aacf4f…
2026-09-14 22:38:342026-08N210852-001113829232035-12-01Drug product2023-06-2784e616aacf4f…
2026-09-14 22:38:342026-08N210852-002108499162035-07-13Drug product2023-06-2784e616aacf4f…
2026-09-14 22:38:342026-08N210852-002113829232035-12-01Drug product2023-06-2784e616aacf4f…
2026-09-14 22:38:342026-08N210852-003108499162035-07-13Drug product2023-06-2784e616aacf4f…
2026-09-14 22:38:342026-08N210852-003113829232035-12-01Drug product2023-06-2784e616aacf4f…
2026-08-18 06:07:402026-07N210852-001108499162035-07-13Drug product2023-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210852-001113829232035-12-01Drug product2023-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210852-002108499162035-07-13Drug product2023-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210852-002113829232035-12-01Drug product2023-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210852-003108499162035-07-13Drug product2023-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210852-003113829232035-12-01Drug product2023-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210852-001108499162035-07-13Drug product2023-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210852-001113829232035-12-01Drug product2023-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210852-002108499162035-07-13Drug product2023-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210852-002113829232035-12-01Drug product2023-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210852-003108499162035-07-13Drug product2023-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210852-003113829232035-12-01Drug product2023-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210852-001108499162035-07-13Drug product2023-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210852-001113829232035-12-01Drug product2023-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210852-002108499162035-07-13Drug product2023-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210852-002113829232035-12-01Drug product2023-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210852-003108499162035-07-13Drug product2023-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210852-003113829232035-12-01Drug product2023-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N210852-001108499162035-07-13Drug product2023-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210852-001113829232035-12-01Drug product2023-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210852-002108499162035-07-13Drug product2023-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210852-002113829232035-12-01Drug product2023-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210852-003108499162035-07-13Drug product2023-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210852-003113829232035-12-01Drug product2023-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210852-001108499162035-07-13Drug product2023-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210852-001113829232035-12-01Drug product2023-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210852-002108499162035-07-13Drug product2023-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210852-002113829232035-12-01Drug product2023-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210852-003108499162035-07-13Drug product2023-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210852-003113829232035-12-01Drug product2023-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210852-001108499162035-07-13Drug product2023-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210852-001113829232035-12-01Drug product2023-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210852-002108499162035-07-13Drug product2023-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210852-002113829232035-12-01Drug product2023-06-27b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Frindovyx
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOPHOSPHAMIDE500 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8N3DW7272PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2703027Internal RxNorm lookup
2703032Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ad8ea65-4c98-487a-9c8d-df778765ec5eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0db1850b-2dc3-47a1-8b35-fab6e1685124Product name320250814
0b38b013-6fe7-0a7a-ece2-0a10ca467a97Product name420250801
f22fb018-dc36-4ffa-a765-94776b98899bProduct name120250620
e71baeca-a07a-452b-ba2b-50be55aedc79Product name220250617
913f6711-71c9-4a3d-a6d5-98cbd101b5d8Product name120231023
cd3d0a71-dbf2-4640-91f7-c99c45edfbb6Product name120231023
fbc3d08d-10bd-4e59-b59d-d530aede5badProduct name120220308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83831-119-01Frindovyx1 mL in 1 VIAL, MULTI-DOSEINJECTION110
83831-119-01Frindovyx1 in 1 CARTONINJECTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83831-119-01ML - Milliliter83831-1197c8aef3c-b78f-40ef-a8d9-841ae2d0dda212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83831-119FRINDOVYX (CYCLOPHOSPHAMIDE) INJECTION [AVYXA PHARMA, LLC]8Current NDC, 2 package rows20250326_5ad8ea65-4c98-487a-9c8d-df778765ec5e.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FrindovyxCYCLOPHOSPHAMIDEAVYXA Pharma, LLC5ad8ea65-4c98-487a-9c8d-df778765ec5e2026-08-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 210852
application number: NDA210852
ndc (product): 83831-119
CyclophosphamideCYCLOPHOSPHAMIDEAvyxa Pharma, LLC6f593585-e0dd-48bc-bd2b-c6c787e0b98c2024-07-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 210852
application number: NDA210852

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2703027cycloPHOSphamide 500 MG/ML Injectable SolutionPSN5ad8ea65-4c98-487a-9c8d-df778765ec5e10
2703032Frindovyx 500 MG/ML Injectable SolutionPSN5ad8ea65-4c98-487a-9c8d-df778765ec5e10
2703032cyclophosphamide 500 MG/ML Injectable Solution [Frindovyx]SBD5ad8ea65-4c98-487a-9c8d-df778765ec5e10
2703027cyclophosphamide 500 MG/ML Injectable SolutionSCD5ad8ea65-4c98-487a-9c8d-df778765ec5e10
2703032Frindovyx 500 MG/ML Injectable SolutionSY5ad8ea65-4c98-487a-9c8d-df778765ec5e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83831-119-01838310119011 VIAL, MULTI-DOSE in 1 CARTON (83831-119-01) / 1 mL in 1 VIAL, MULTI-DOSE2025-03-19NoNoCurrent