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DIGOXIN

ANDA

DIGOXIN | A214982 | AUROBINDO PHARMA LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LANOXIN(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 6 NDCs

Highest NADAC/Unit

$8.53

per ea

Lowest NADAC/Unit

$0.1324

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59651043601DIGOXIN 62.5 MCG TABLET	$8.53	EA	Generic	—	2026-08-19
59651043801DIGOXIN 250 MCG TABLET	$0.1614	EA	Generic	—	2026-08-19
59651043899DIGOXIN 250 MCG TABLET	$0.1614	EA	Generic	—	2026-08-19
59651043701DIGOXIN 125 MCG TABLET	$0.1324	EA	Generic	—	2026-08-19
59651043799DIGOXIN 125 MCG TABLET	$0.1324	EA	Generic	—	2026-08-19
50268023815DIGOXIN 125 MCG TABLET	$0.1324	EA	Generic	—	2026-08-19

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

API Supply Chain3 active DMFs8 inactive

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

C-SQUARED PHARMA LTDDIGOXIN

DMF 244182010

ALKALOIDS CORPDIGOXIN 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
Aug 4, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.0625MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 8, 2022

No patent or exclusivity listings for this strength.

#002 — 0.125MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 8, 2022

#003 — 0.25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 8, 2022