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DIGOXIN

ANDA

DIGOXIN | A076268 | JEROME STEVENS PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LANOXIN(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 8 NDCs

Highest NADAC/Unit

$0.1600

per ea

Lowest NADAC/Unit

$0.1210

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69238199201DIGOXIN 250 MCG TABLET	$0.1600	EA	Generic	—	2026-06-17
69238199207DIGOXIN 250 MCG TABLET	$0.1600	EA	Generic	—	2026-06-17
82685020201DIGOXIN 250 MCG TABLET	$0.1600	EA	Generic	—	2026-06-17
82685020210DIGOXIN 250 MCG TABLET	$0.1600	EA	Generic	—	2026-06-17
82685020101DIGOXIN 125 MCG TABLET	$0.1210	EA	Generic	—	2026-06-17
69238199107DIGOXIN 125 MCG TABLET	$0.1210	EA	Generic	—	2026-06-17
69238199101DIGOXIN 125 MCG TABLET	$0.1210	EA	Generic	—	2026-06-17
82685020110DIGOXIN 125 MCG TABLET	$0.1210	EA	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 | 12 NDCs (8 FSS, 4 NC)

Lowest Price

$7.61

Highest Price

$158.83

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
69238-1991-01DIGOXIN 0.125MG TAB	$15.89	FSS	AvKare, LLC	06/14/2028
69238-1991-07DIGOXIN 0.125MG TAB	$158.83	FSS	AvKare, LLC	06/14/2028
69238-1992-01DIGOXIN 0.25MG TAB	$15.89	FSS	AvKare, LLC	06/14/2028
69238-1992-07DIGOXIN 0.25MG TAB	$158.83	FSS	AvKare, LLC	06/14/2028
72162-2268-02DIGOXIN 125MCG TAB	$63.90	NC	Bryant Ranch Prepack	09/16/2026
72162-2268-04DIGOXIN 125MCG TAB	$7.61	NC	Bryant Ranch Prepack	09/16/2026

Showing 6 of 12 NDCs.

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

API Supply Chain3 active DMFs8 inactive

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

C-SQUARED PHARMA LTDDIGOXIN

DMF 244182010

DECCAN NUTRACEUTICALS PVT LTDDIGOXIN MICRO USP

DMF 286282014

ALCHEM INTERNATIONAL PRIVATE LTDDIGOXIN USP

DMF 307242016

RP SCHERER CORPInactiveDIGOXIN CAPS

DMF 22531974

ROCHE DIAGNOSTICS GMBHInactiveDIGOXIN PRODUCTS

DMF 22771974

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveDIGOXIN

DMF 69261987

PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE COInactiveDIGOXIN DRUG SUBSTANCE

DMF 100671993

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveDIGOXIN 20 MICROMETER

DMF 215592008

VITAL LABORATORIES PVT LTDInactiveDIGOXIN

DMF 241352010

ALCHEM INTERNATIONAL LTDInactiveDIGOXIN USP

DMF 276052013

C-SQUARED PHARMA SARLInactiveDIGOXIN (MICRON)

DMF 330352019

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 24, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.125MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 26, 2002

No patent or exclusivity listings for this strength.

#002 — 0.25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 26, 2002