Viewing data from:

IRBESARTAN

ANDA

IRBESARTAN | A203020 | UNICHEM LABORATORIES LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: AVAPRO(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs

Highest NADAC/Unit

$0.1530

per ea

Lowest NADAC/Unit

$0.0807

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
29300021413IRBESARTAN 300 MG TABLET	$0.1530	EA	Generic	—	2026-06-17
29300021419IRBESARTAN 300 MG TABLET	$0.1530	EA	Generic	—	2026-06-17
29300021313IRBESARTAN 150 MG TABLET	$0.1111	EA	Generic	—	2026-06-17
29300021319IRBESARTAN 150 MG TABLET	$0.1111	EA	Generic	—	2026-06-17
29300021213IRBESARTAN 75 MG TABLET	$0.0807	EA	Generic	—	2026-06-17
29300021219IRBESARTAN 75 MG TABLET	$0.0807	EA	Generic	—	2026-06-17

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

API Supply Chain24 active DMFs18 inactive

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

SANOFI CHIMIEIRBESARTAN DRUG SUBSTANCE

DMF 103101993

TAPI NL BVIRBESARTAN

DMF 173942004

HETERO LABS LTDIRBESARTAN (FORM A) PROCESS I

DMF 175072004

MATRIX PHARMACORP PRIVATE LTDIRBESARTAN USP

DMF 179122004

EUROAPI HUNGARY LTDIRBESARTAN DRUG SUBSTANCE

DMF 196902006

JUBILANT BIOSYS LTDIRBESARTAN USP

DMF 197902006

DR REDDYS LABORATORIES LTDIRBESARTAN USP

DMF 200082006

ZYDUS LIFESCIENCES LTDIRBESARTAN USP

DMF 203612007

ALEMBIC PHARMACEUTICALS LTDIRBESARTAN USP

DMF 203782007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDIRBESARTAN USP

DMF 217802008

APITORIA PHARMA PRIVATE LTDIRBESARTAN USP (NON-STERILE DRUG SUBSTANCE)

DMF 230842009

MACLEODS PHARMACEUTICALS LTDIRBESARTAN

DMF 234492010

UNICHEM LABORATORIES LTDIRBESARTAN USP

DMF 238352010

CALYX CHEMICALS AND PHARMACEUTICALS LTDIRBESARTAN

DMF 240172010

CTX LIFE SCIENCES PVT LTDIRBESARTAN USP

DMF 245962011

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDIRBESARTAN API

DMF 247522011

MICRO LABS LTDIRBESARTAN USP

DMF 248342011

TAPI NL BVIRBESARTAN USP

DMF 254832011

ULKAR KIMYA SANAYII VE TICARET ASIRBESARTAN USP

DMF 258612012

PIRAMAL PHARMA LTDIRBESARTAN

DMF 266842012

ZHUHAI RUNDU PHARMACEUTICAL CO LTDIRBESARTAN, NON-STERILE BULK DRUG SUBSTANCE

DMF 328032019

MSN LIFE SCIENCES PRIVATE LTDIRBESARTAN USP

DMF 360682021

SYNERGENE ACTIVE INGREDIENTS PRIVATE LTDIRBESARTAN USP

DMF 389562023

DIVIS LABORATORIES LTDIRBESARTAN USP

DMF 390962023

SA AJINOMOTO OMNICHEM NVInactiveIRBESARTAN CRUDE

DMF 128701998

BRISTOL MYERS SQUIBB COInactiveIRBESARTAN

DMF 128821998

BRISTOL MYERS SQUIBB COInactiveIRBESARTAN

DMF 132651998

BASF PHARMA EVIONNAZ SAInactiveIRBESARTAN(SR47436)

DMF 154062001

RANBAXY LABORATORIES LTDInactiveIRBESARTAN USP

DMF 177962004

QUIMICA SINTETICA SAInactiveIRBESARTAN

DMF 187462005

USV PRIVATE LTDInactiveIRBESARTAN USP

DMF 201482007

CIPLA LTDInactiveIRBESARTAN

DMF 201762008

LUPIN LTDInactiveIRBESARTAN USP

DMF 201982007

CADILA PHARMACEUTICALS LTDInactiveIRBESARTAN (POLYMORPHIC FORM-A)

DMF 213692007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveIRBESARTAN

DMF 217542008

SIGNA SA DE CVInactiveIRBESARTAN USP

DMF 233472009

LUPIN LTDInactiveIRBESARTAN USP (PROCESS B)

DMF 233982010

HETERO LABS LTDInactiveIRBESARTAN (FORM A) PROCESS II

DMF 246652011

CADILA HEALTHCARE LTDInactiveIRBESARTAN USP

DMF 254462011

ZHUHAI RUNDU PHARMACEUTICAL CO LTDInactiveIRBESARTAN

DMF 255092011

DIVIS LABORATORIES LTDInactiveIRBESARTAN USP

DMF 264182012

HEC PHARM CO LTDInactiveIRBESARTAN NON-STERILE BULK DRUG SUBSTANCE

DMF 268022013

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 9, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 75MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 7, 2015

No patent or exclusivity listings for this strength.

#002 — 150MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 7, 2015

#003 — 300MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 7, 2015