Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Nephro-Tech, Inc.
878520485
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
LGM Pharma
Nephro-Tech, Inc.
Nephro-Tech, Inc.
117549200
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NephPlex Rx
Product Details
NDC Product Code
59528-0317Route of Administration
ORALEffective Date
July 13, 2021DexpanthenolActive
Code: 19F5HK2737Class: ACTIBQuantity: 10 mg in 1 1
ThiamineActive
Code: X66NSO3N35Class: ACTIBQuantity: 1.5 mg in 1 1
Zinc oxideActive
Code: SOI2LOH54ZClass: ACTIMQuantity: 12.5 mg in 1 1
NicotinamideActive
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
PyridoxineActive
Code: 68Y4CF58BVClass: ACTIBQuantity: 10 mg in 1 1
RiboflavinActive
Code: TLM2976OFRClass: ACTIBQuantity: 1.7 mg in 1 1
Folic acidActive
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: .3 mg in 1 1
Vitamin B12Active
Code: 8406EY2OQAClass: ACTIBQuantity: .006 mg in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 60 mg in 1 1