Viewing data from:

LEVETIRACETAM

ANDA

LEVETIRACETAM | A215069 | SCIEGEN PHARMACEUTICALS INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: KEPPRA(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 7 NDCs

Highest NADAC/Unit

$0.1566

per ea

Lowest NADAC/Unit

$0.0584

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50228047360LEVETIRACETAM 1,000 MG TABLET	$0.1566	EA	Generic	—	2026-08-19
50228047212LEVETIRACETAM 750 MG TABLET	$0.1105	EA	Generic	—	2026-08-19
50228047205LEVETIRACETAM 750 MG TABLET	$0.1105	EA	Generic	—	2026-08-19
50228047112LEVETIRACETAM 500 MG TABLET	$0.0739	EA	Generic	—	2026-08-19
50228047105LEVETIRACETAM 500 MG TABLET	$0.0739	EA	Generic	—	2026-08-19
50228047005LEVETIRACETAM 250 MG TABLET	$0.0584	EA	Generic	—	2026-08-19
50228047012LEVETIRACETAM 250 MG TABLET	$0.0584	EA	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 7 NDCs (7 FSS)

Lowest Price

$5.05

Highest Price

$46.55

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50228-0470-05LEVETIRACETAM 250MG TAB	$20.45	FSS	Sterisyn Inc.	05/31/2029
50228-0470-12LEVETIRACETAM 250MG TAB	$5.05	FSS	Sterisyn Inc.	05/31/2029
50228-0471-05LEVETIRACETAM 500MG TAB	$32.95	FSS	Sterisyn Inc.	05/31/2029
50228-0471-12LEVETIRACETAM 500MG TAB	$7.85	FSS	Sterisyn Inc.	05/31/2029
50228-0472-05LEVETIRACETAM 750MG TAB	$46.55	FSS	Sterisyn Inc.	05/31/2029
50228-0472-12LEVETIRACETAM 750MG TAB	$11.15	FSS	Sterisyn Inc.	05/31/2029
50228-0473-60LEVETIRACETAM 1000MG TAB	$8.25	FSS	Sterisyn Inc.	05/31/2029

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

API Supply Chain30 active DMFs18 inactive

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

DIVIS LABORATORIES LTDLEVETIRACETAM

DMF 168942003

DR REDDYS LABORATORIES LTDLEVETIRACETAM

DMF 169662003

HETERO LABS LTDLEVETIRACETAM (FORM 1)

DMF 177382004

NEULAND LABORATORIES LTDLEVETIRACETAM USP

DMF 177992004

LUPIN LTDLEVETIRACETAM USP

DMF 190802005

APITORIA PHARMA PRIVATE LTDLEVETIRACETAM USP

DMF 193872006

ORBION PHARMACEUTICALS PRIVATE LTDLEVETIRACETAM

DMF 197472006

SUN PHARMACEUTICAL INDUSTRIES LTDLEVETIRACETAM USP

DMF 214142008

ESTEVE QUIMICA SALEVETIRACETAM INJECTABLE GRADE/NON-STERILE

DMF 218372008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLEVETIRACETAM USP (PROCESS II)

DMF 238532010

JUBILANT PHARMOVA LTDLEVETIRACETAM USP

DMF 242002010

SRINI PHARMACEUTICALS PRIVATE LTDLEVETIRACETAM USP

DMF 247572011

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDLEVETIRACETAM

DMF 250052011

AMOLI ORGANICS PVT LTDLEVETIRACETAM USP [ROUTE CODE - LVS]

DMF 257622012

SOLARA ACTIVE PHARMA SCIENCES LTDLEVETIRACETAM USP

DMF 265002012

SMS PHARMACEUTICALS LTDLEVETIRACETAM USP

DMF 284312014

DIVIS LABORATORIES LTDLEVETIRACETAM (PROCESS B)

DMF 301852016

HETERO LABS LTDLEVETIRACETAM (FORM-1), PROCESS-II

DMF 306262016

MSN LIFE SCIENCES PRIVATE LTDLEVETIRACETAM USP

DMF 336082019

AURORE LIFE SCIENCES PRIVATE LTDLEVETIRACETAM USP

DMF 340972019

INNOVARE LABS PRIVATE LTDLEVETIRACETAM USP

DMF 345932020

AURORE LIFE SCIENCES PRIVATE LTDLEVETIRACETAM FORM-I USP

DMF 352722020

CHIERON ACTIVE INGREDIENTS PRIVATE LTDLEVETIRACETAM

DMF 353162020

EMNAR PHARMA PRIVATE LTDLEVETIRACETAM USP

DMF 354412020

SHAOXING JINGXIN PHARMACEUTICALS CO LTDLEVETIRACETAM

DMF 356292021

IOL CHEMICALS AND PHARMACEUTICALS LTDLEVETIRACETAM USP

DMF 363742021

GRANULES INDIA LTDLEVETIRACETAM USP

DMF 377752022

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLEVETIRACETAM, USP (PROCESS VII)

DMF 378522022

VASUDHA PHARMA CHEM LTDLEVETIRACETAM USP

DMF 381302023

RUI LABORATORIES PRIVATE LIMITEDLEVETIRACETAM USP

DMF 412452025

ESTEVE QUIMICA SAInactiveLEVETIRACETAM

DMF 173272004

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveLEVETIRACETAM

DMF 190332005

RANBAXY LABORATORIES LTDInactiveLEVETIRACETAM

DMF 190512005

HIKAL LTDInactiveLEVETIRACETAM API

DMF 191042006

CAMBREX CHARLES CITY INCInactiveLEVETIRACETAM

DMF 197382006

SIGNA SA DE CVInactiveLEVETIRACETAM USP

DMF 204122007

ALEMBIC PHARMACEUTICALS LTDInactiveLevetiracetam

DMF 211222007

MYLAN LABORATORIES LTDInactiveLEVETIRACETAM USP

DMF 212012007

WANBURY LTDInactiveLEVETIRACETAM

DMF 217432008

ZACH SYSTEM SPAInactiveLEVETIRACETAM

DMF 217472008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveLEVETIRACETAM USP

DMF 222352008

AMOLI ORGANICS PVT LTDInactiveLEVETIRACETAM

DMF 235852010

SECOND PHARMA CO LTDInactiveLEVETIRACETAM

DMF 251202011

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDInactiveLEVETIRACETAM

DMF 261942012

CTX LIFE SCIENCES PVT LTDInactiveLEVETIRACETAM

DMF 274582013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveLEVETIRACETAM USP (PROCESS V)

DMF 301192015

WANBURY LTDInactiveLEVETIRACETAM

DMF 311492016

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDInactiveLEVETIRACETAM

DMF 342222019

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 14, 2021	ORIG -1	View Letter (PDF)
Jul 14, 2021	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 750MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 11, 2021

No patent or exclusivity listings for this strength.

#002 — 1GM

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 11, 2021

#003 — 250MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 27, 2022

#004 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 27, 2022