Viewing data from:

FELBAMATE

ANDA

FELBAMATE | A201680 | AMNEAL PHARMACEUTICALS

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FELBATOL(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 6 NDCs

Highest NADAC/Unit

$1.05

per ea

Lowest NADAC/Unit

$0.8512

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
65162073509FELBAMATE 600 MG TABLET	$1.05	EA	Generic	—	2026-10-21
65162073518FELBAMATE 600 MG TABLET	$1.05	EA	Generic	—	2026-10-21
53746073518FELBAMATE 600 MG TABLET	$1.05	EA	Generic	—	2026-10-21
53746073590FELBAMATE 600 MG TABLET	$1.05	EA	Generic	—	2026-10-21
65162073409FELBAMATE 400 MG TABLET	$0.8512	EA	Generic	—	2026-10-21
53746073490FELBAMATE 400 MG TABLET	$0.8512	EA	Generic	—	2026-10-21

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

API Supply Chain8 active DMFs5 inactive

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

SIEGFRIED EVIONNAZ SAFELBAMATE

DMF 83041989

PROCOS SPAFELBAMATE

DMF 212472008

SOLARA ACTIVE PHARMA SCIENCES LTDFELBAMATE

DMF 228102009

MATRIX PHARMACORP PRIVATE LTDFELBAMATE USP

DMF 229582009

TARO PHARMACEUTICAL INDUSTRIES LTDFELBAMATE USP

DMF 273312013

EMCURE PHARMACEUTICALS LTDFELBAMATE USP

DMF 294082015

RAKS PHARMA PVT LTDFELBAMATE USP

DMF 311812016

MATRIX PHARMACORP PRIVATE LTDFELBAMATE USP (FEL)

DMF 392072023

ZACH SYSTEMInactiveFELBAMATE

DMF 92681991

GANES CHEMICALS INC PENNSVILLE DIVInactiveFELBAMATE

DMF 93521991

APICORE US LLCInactiveFELBAMATE

DMF 204382007

HETERO DRUGS LTDInactiveFELBAMATE

DMF 222012008

ENALTEC LABS PRIVATE LTDInactiveFELBAMATE USP

DMF 286612015

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 15, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 400MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 13, 2011

No patent or exclusivity listings for this strength.

#002 — 600MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 13, 2011