Orange Book product · Brand (NDA)
EPIOXA HD/EPIOXA KIT
RIBOFLAVIN 5'-PHOSPHATE SODIUM
At a glance
Oct 17, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 17, 2025
8 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
Pharmaceutical detail
Active ingredient
RIBOFLAVIN 5'-PHOSPHATE SODIUM
Strength
EQ 0.239% BASE/ML;EQ 0.177% BASE/ML
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 219910
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
