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DILANTIN

ANDA

PHENYTOIN SODIUM | A084349 | VIATRIS SPECIALTY LLC

2 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 4 NDCs

Highest NADAC/Unit

$1.74

per ea

Lowest NADAC/Unit

$1.50

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
58151011001DILANTIN 100 MG CAPSULE	$1.74	EA	—	$0.1438	2026-10-21
58151011010DILANTIN 100 MG CAPSULE	$1.74	EA	—	$0.1438	2026-10-21
58151011088DILANTIN 100 MG CAPSULE	$1.74	EA	—	$0.1438	2026-10-21
58151011801DILANTIN 30 MG CAPSULE	$1.50	EA	—	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$55.31

Highest Price

$641.62

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
58151-0110-01DILANTIN EXTENDED 100MG CAP	$64.16	FSS	Mylan Specialty L.P.	01/14/2027
58151-0110-10DILANTIN EXTENDED 100MG CAP	$641.62	FSS	Mylan Specialty L.P.	01/14/2027
58151-0110-88DILANTIN EXTENDED 100MG CAP UD	$70.80	FSS	Mylan Specialty L.P.	01/14/2027
58151-0118-01DILANTIN EXTENDED 30MG CAP	$55.31	FSS	Mylan Specialty L.P.	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAPHENYTOIN SODIUM

DMF 45381982

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFEPHENYTOIN SODIUM

DMF 163012002

HARMAN FINOCHEM LTDPHENYTOIN SODIUM USP

DMF 178622004

KUNSHAN ORIENTAL PHARMACEUTICAL CO LTDPHENYTOIN SODIUM

DMF 204332007

ORCHID PHARMA LTDPHENYTOIN SODIUM

DMF 204532007

UNICHEM LABORATORIES LTDPHENYTOIN SODIUM USP

DMF 326762018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Oct 2, 2020	SUPPL -86	View Letter (PDF)
Apr 23, 2015	SUPPL -74	View Letter (PDF)
Mar 6, 2014	SUPPL -62	View Letter (PDF)
Mar 6, 2014	SUPPL -72	View Letter (PDF)
Aug 8, 2013	SUPPL -70	View Letter (PDF)
Dec 6, 2012	SUPPL -67	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 30MG EXTENDED

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 100MG EXTENDED

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982