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VALGANCICLOVIR HYDROCHLORIDE

ANDA

VALGANCICLOVIR HYDROCHLORIDE | A205220 | ACTAVIS LABORATORIES FL INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: VALCYTE(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$1.10

per ml

Lowest NADAC/Unit

$1.10

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00591257920VALGANCICLOVIR HCL 50 MG/ML	$1.10	ML	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$399.95

Highest Price

$399.95

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42291-0972-01VALGANCICLOVIR HCL 50MG/ML SOLN,ORAL	$399.95	FSS	AvKare, LLC	06/14/2028

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

API Supply Chain19 active DMFs5 inactive

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

OLON SPAVALGANCICLOVIR HYDROCHLORIDE AMORPHOUS

DMF 230442009

MATRIX PHARMACORP PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE)

DMF 233222009

MATRIX PHARMACORP PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE) FORM A

DMF 238592010

DR REDDYS LABORATORIES LTDVALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE)

DMF 248182011

DR REDDYS LABORATORIES LTDVALGANCICLOVIR HYDROCHLORIDE USP (AMORPHOUS)

DMF 248312011

HETERO DRUGS LTDVALGANCICLOVIR HYDROCHLORIDE, USP

DMF 260792012

APITORIA PHARMA PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 263142012

CALYX CHEMICALS AND PHARMACEUTICALS LTDVALGANCICLOVIR HYDROCHLORIDE

DMF 268892012

CIPLA LTDVALGANCICLOVIR HYDROCHLORIDE USP

DMF 283602014

CORDEN PHARMA COLORADO INCVALGANCICLOVIR HYDROCHLORIDE

DMF 300232015

PHARMATHEN SAVALGANCICLOVIR HYDROCHLORIDE

DMF 315462017

OLON SPAVALGANCICLOVIR HYDROCHLORIDE CRYSTALLINE

DMF 324882018

AURORE LIFE SCIENCES PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP

DMF 346002020

MAITHRI LABORATORIES PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP

DMF 346172020

SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDVALGANCICLOVIR HYDROCHLORIDE

DMF 351072021

AJANTA PHARMA LTDVALGANCICLOVIR HYDROCHLORIDE USP (Crystalline)

DMF 361942021

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDVALGANCICLOVIR HYDROCHLORIDE

DMF 388912023

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDVALGANCICLOVIR HYDROCHLORIDE

DMF 420832025

APITORIA PHARMA PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP (PROCESS-II)

DMF 438352026

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveVALGANCICLOVIR HYDROCHLORIDE (NON-STERILE BULK)

DMF 190602005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveVALGANCICLOVIR HYDROCHLORIDE, USP (PROCESS 2; SITE TOANSA)

DMF 239462010

APOTEX PHARMACHEM INDIA PVT LTDInactiveVALGANCICLOVIR HYDROCHLORIDE USP

DMF 244342010

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveVALGANCICLOVIR HYDROCHLORIDE, CRYSTALLINE (DRUG SUBSTANCE)

DMF 264222012

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveVALGANCICLOVIR HYDROCHLORIDE, AMORPHOUS (DRUG SUBSTANCE)

DMF 265972012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 22, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/ML

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Jul 18, 2016

No patent or exclusivity listings for this strength.