Home NDC 83831-120 Frindovyx
Product NDC 83831-120
11-digit product format 838310120
Labeler code 83831
Product ID 83831-120_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 1 g/2mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210852-001 FRINDOVYX CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 N210852-002 FRINDOVYX CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 N210852-003 FRINDOVYX CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210852-001 10849916 2035-07-13 Drug product 2023-06-27 N210852-001 11382923 2035-12-01 Drug product 2023-06-27 N210852-002 10849916 2035-07-13 Drug product 2023-06-27 N210852-002 11382923 2035-12-01 Drug product 2023-06-27 N210852-003 10849916 2035-07-13 Drug product 2023-06-27 N210852-003 11382923 2035-12-01 Drug product 2023-06-27
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N210852-001 FRINDOVYX 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210852-002 FRINDOVYX 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210852-003 FRINDOVYX 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210852-001 FRINDOVYX 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210852-002 FRINDOVYX 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210852-003 FRINDOVYX 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210852-001 FRINDOVYX 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210852-002 FRINDOVYX 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210852-003 FRINDOVYX 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210852-001 FRINDOVYX 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210852-002 FRINDOVYX 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210852-003 FRINDOVYX 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210852-001 CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210852-002 CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210852-003 CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210852-001 CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210852-002 CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210852-003 CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210852-001 CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210852-002 CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210852-003 CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210852-001 CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210852-002 CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210852-003 CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210852-001 CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210852-002 CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210852-003 CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210852-001 CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210852-002 CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210852-003 CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210852-001 CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210852-002 CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210852-003 CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210852-001 CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210852-002 CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210852-003 CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210852-001 CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210852-002 CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210852-003 CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210852-001 CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-06-07 301d65b070ca…
Observed Orange Book patent history# Patent history page 1 of 4 · 138 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N210852-001 10849916 2035-07-13 Drug product 2023-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210852-001 11382923 2035-12-01 Drug product 2023-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210852-002 10849916 2035-07-13 Drug product 2023-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210852-002 11382923 2035-12-01 Drug product 2023-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210852-003 10849916 2035-07-13 Drug product 2023-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210852-003 11382923 2035-12-01 Drug product 2023-06-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210852-001 10849916 2035-07-13 Drug product 2023-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210852-001 11382923 2035-12-01 Drug product 2023-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210852-002 10849916 2035-07-13 Drug product 2023-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210852-002 11382923 2035-12-01 Drug product 2023-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210852-003 10849916 2035-07-13 Drug product 2023-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210852-003 11382923 2035-12-01 Drug product 2023-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210852-001 10849916 2035-07-13 Drug product 2023-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210852-001 11382923 2035-12-01 Drug product 2023-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210852-002 10849916 2035-07-13 Drug product 2023-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210852-002 11382923 2035-12-01 Drug product 2023-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210852-003 10849916 2035-07-13 Drug product 2023-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210852-003 11382923 2035-12-01 Drug product 2023-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210852-001 10849916 2035-07-13 Drug product 2023-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210852-001 11382923 2035-12-01 Drug product 2023-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210852-002 10849916 2035-07-13 Drug product 2023-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210852-002 11382923 2035-12-01 Drug product 2023-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210852-003 10849916 2035-07-13 Drug product 2023-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210852-003 11382923 2035-12-01 Drug product 2023-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210852-001 10849916 2035-07-13 Drug product 2023-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210852-001 11382923 2035-12-01 Drug product 2023-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210852-002 10849916 2035-07-13 Drug product 2023-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210852-002 11382923 2035-12-01 Drug product 2023-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210852-003 10849916 2035-07-13 Drug product 2023-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210852-003 11382923 2035-12-01 Drug product 2023-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210852-001 10849916 2035-07-13 Drug product 2023-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210852-001 11382923 2035-12-01 Drug product 2023-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210852-002 10849916 2035-07-13 Drug product 2023-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210852-002 11382923 2035-12-01 Drug product 2023-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210852-003 10849916 2035-07-13 Drug product 2023-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210852-003 11382923 2035-12-01 Drug product 2023-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210852-001 10849916 2035-07-13 Drug product 2023-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210852-001 11382923 2035-12-01 Drug product 2023-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210852-002 10849916 2035-07-13 Drug product 2023-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210852-002 11382923 2035-12-01 Drug product 2023-06-27 b8a1b40f171c…
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 Ingredient Strength CYCLOPHOSPHAMIDE 1 g/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8N3DW7272P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2703027 Internal RxNorm lookup 2703032 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 83831-120-02 Frindovyx 2 mL in 1 VIAL, MULTI-DOSE INJECTION 2 10 83831-120-02 Frindovyx 1 in 1 CARTON INJECTION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83831-120 FRINDOVYX (CYCLOPHOSPHAMIDE) INJECTION [AVYXA PHARMA, LLC] 8 Current NDC, 2 package rows 20250326_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83831-120-02 83831012002 1 VIAL, MULTI-DOSE in 1 CARTON (83831-120-02) / 2 mL in 1 VIAL, MULTI-DOSE 2025-03-19 No No Current