Viewing data from:

ARMODAFINIL

ANDA

ARMODAFINIL | A202768 | NATCO PHARMA LTD

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: NUVIGIL(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.8238

per ea

Lowest NADAC/Unit

$0.2871

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69339017903ARMODAFINIL 200 MG TABLET	$0.8238	EA	Generic	—	2026-06-17
69339017703ARMODAFINIL 50 MG TABLET	$0.2871	EA	Generic	—	2026-06-17

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

API Supply Chain10 active DMFs3 inactive

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

CEPHALON INCARMODAFINIL DRUG SUBSTANCE

DMF 196852006

MATRIX PHARMACORP PRIVATE LTDARMODAFINIL

DMF 212002007

ACTAVIS GROUP PTC EHFARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE)

DMF 229832009

LUPIN LTDARMODAFINIL

DMF 231342009

UNIMARK REMEDIES LTDARMODAFINIL

DMF 249452011

ORCHID PHARMA LTDARMODAFINIL

DMF 250312011

APITORIA PHARMA PRIVATE LTDARMODAFINIL

DMF 273022013

TAPI NL BVARMODAFINIL 7SM1029

DMF 303502016

PIRAMAL PHARMA LTDARMODAFINIL

DMF 304052016

CHROMO LABORATORIES INDIA PRIVATE LTDARMODAFINIL

DMF 407322025

SIGMA ALDRICH IRELAND LTDInactiveARMODAFINIL DRUG SUBSTANCE

DMF 181072005

NOVASEP PROCESS SASInactiveARMODAFINIL

DMF 181092005

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveARMODAFINIL

DMF 229572009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 21, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 28, 2016

No patent or exclusivity listings for this strength.

#002 — 150MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 28, 2016

#003 — 250MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 28, 2016

#004 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 28, 2017

#005 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 28, 2017