Viewing data from:

CARVEDILOL

ANDA

CARVEDILOL | A078227 | SANDOZ INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: COREG(TE code: AB)

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.0184

per ea

Lowest NADAC/Unit

$0.0170

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00781522201CARVEDILOL 6.25 MG TABLET	$0.0184	EA	Generic	—	2026-06-17
00781522101CARVEDILOL 3.125 MG TABLET	$0.0170	EA	Generic	—	2026-06-17

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

API Supply Chain18 active DMFs12 inactive

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

TAPI NL BVCARVEDILOL USP

DMF 158652002

MOEHS IBERICA SLCARVEDILOL

DMF 160442002

DR REDDYS LABORATORIES LTDCARVEDILOL (FORM-2) USP

DMF 163302003

ZAKLADY FARMACEUTYCZNE POLPHARMA SACARVEDILOL

DMF 170602003

SUN PHARMACEUTICAL INDUSTRIES LTDCARVEDILOL USP

DMF 175902004

ZYDUS LIFESCIENCES LTDCARVEDILOL USP

DMF 179472004

TARO PHARMACEUTICAL INDUSTRIES LTDCARVEDILOL

DMF 181452005

MATRIX PHARMACORP PRIVATE LTDCARVEDILOL USP

DMF 184992005

APITORIA PHARMA PRIVATE LTDCARVEDILOL USP

DMF 191062006

LUPIN LTDCARVEDILOL

DMF 192182006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCARVEDILOL USP

DMF 195332006

IPCA LABORATORIES LTDCARVEDILOL USP

DMF 209302007

RAKS PHARMA PVT LTDCARVEDILOL USP

DMF 237432010

CTX LIFE SCIENCES PVT LTDCARVEDILOL (ROUTE-II)

DMF 240962010

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCARVEDILOL DIHYDROGEN PHOSPHATE HEMIHYDRATE USP

DMF 257212011

CADILA PHARMACEUTICALS LTDCARVEDILOL USP

DMF 281392014

SHODHANA LABORATORIES PRIVATE LTDCARVEDILOL [USP]

DMF 399382024

ALIVUS LIFE SCIENCES LTDCARVEDILOL USP

DMF 416052025

ZENTIVA ASInactiveCARVEDILOL

DMF 165302003

CIPLA LTDInactiveCARVEDILOL USP

DMF 171872004

ZACH SYSTEM SPAInactiveCARVEDILOL

DMF 174052004

USV LTDInactiveCARVEDILOL PH. EUR.

DMF 174872004

URQUIMA SAInactiveCARVEDILOL, MICRONIZED

DMF 181582005

CADILA PHARMACEUTICALS LTDInactiveCARVEDILOL

DMF 185152005

ORCHID CHEMICALS AND PHARMACEUTICALS LTDInactiveCARVEDILOL

DMF 193732006

CAMBREX CHARLES CITY INCInactiveCARVEDILOL

DMF 199362006

WANBURY LTDInactiveCARVEDILOL

DMF 203082007

ROCHE DIAGNOSTICS GMBHInactiveCARVEDILOL

DMF 205872007

CADILA HEALTHCARE LTDInactiveCARVEDILOL (FORM II)

DMF 220432008

APOTEX PHARMACHEM INDIA PVT LTDInactiveCARVEDILOL DIHYDROGEN PHOSPHATE

DMF 301122016

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 7, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 3.125MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 5, 2007

No patent or exclusivity listings for this strength.

#002 — 6.25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 5, 2007

#003 — 12.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 5, 2007

#004 — 25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 5, 2007