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CAPECITABINE

ANDA

CAPECITABINE | A210203 | HETERO LABS LTD UNIT V

2 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.4862

per ea

Lowest NADAC/Unit

$0.3615

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
31722077512CAPECITABINE 500 MG TABLET	$0.4862	EA	Generic	—	2026-06-17
31722077560CAPECITABINE 500 MG TABLET	$0.4862	EA	Generic	—	2026-06-17
68001064407CAPECITABINE 500 MG TABLET	$0.4862	EA	Generic	—	2026-06-17
72603030301CAPECITABINE 500 MG TABLET	$0.4862	EA	Generic	—	2026-06-17
31722077460CAPECITABINE 150 MG TABLET	$0.3615	EA	Generic	—	2026-06-17
68001064306CAPECITABINE 150 MG TABLET	$0.3615	EA	Generic	—	2026-06-17

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

API Supply Chain18 active DMFs13 inactive

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

HETERO LABS LTDCAPECITABINE, USP

DMF 221402008

DIVI'S LABOTATORIES LTDCAPECITABINE

DMF 221572008

DR REDDYS LABORATORIES LTDCAPECITABINE USP

DMF 224792009

AARTI PHARMALABS LTDCAPECITABINE

DMF 229542009

RELIANCE LIFE SCIENCES PVT LTDCAPECITABINE USP

DMF 238082010

SCINOPHARM TAIWAN LTDCAPECITABINE

DMF 241262010

INTAS PHARMACEUTICALS LTDCAPECITABINE USP

DMF 243702010

SHILPA PHARMA LIFESCIENCES LTDCAPECITABINE USP

DMF 246892011

CDYMAX (INDIA) PHARMA PRIVATE LTDCAPECITABINE USP [DRUG SUBSTANCE (NON-STERILE)]

DMF 250542011

ARCHIMICA SPACAPECITABINE

DMF 252662011

SUN PHARMACEUTICAL INDUSTRIES LTDCAPECITABINE USP

DMF 260182012

MSN LABORATORIES PRIVATE LTDCAPECITABINE USP [ROUTE CODE - "CT"]

DMF 260782012

LIANYUNGANG GUIKE PHARMACEUTICAL CO LTDCAPECITABINE (NON-STERILE, BULK FORM)

DMF 268182013

SHANDONG ANXIN PHARMACEUTICAL CO LTDCAPECITABINE (NON-STERILE API)

DMF 270852013

TAPI NL BVCAPECITABINE

DMF 292092015

INTAS PHARMACEUTICALS LTDCAPECITABINE USP (PROCESS III)

DMF 335742019

VANNSH LIFE SCIENCES PRIVATE LIMITEDCAPECITABINE USP

DMF 395632024

EMNAR PHARMA PRIVATE LTDCAPECITABINE

DMF 418552025

CIPLA LTDInactiveCAPECITABINE USP

DMF 216202009

JIANGSU ZW PHARMACEUTICALS CO LTDInactiveCAPECITABINE

DMF 220142008

MYLAN LABORATORIES LTDInactiveCAPECITABINE USP

DMF 236852010

CADILA HEALTHCARE LTDInactiveCAPECITABINE USP

DMF 245172011

QILU TIANHE PHARMACEUTICAL CO LTDInactiveCAPECITABINE (NON-STERILE API)

DMF 245292010

JIANGSU HENGRUI MEDICINE CO LTDInactiveCAPECITABINE USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 255212011

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDInactiveCAPECITABINE

DMF 255922011

APOTEX PHARMACHEM INDIA PVT LTDInactiveCAPECITABINE USP

DMF 257202012

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveCAPECITABINE

DMF 264032012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveCAPECITABINE USP

DMF 269932013

MAC CHEM PRODUCTS INDIA PVT LTDInactiveCAPECITABINE

DMF 270262013

DR REDDYS LABORATORIES LTDInactiveCAPECITABINE [PROCESS-II]

DMF 285382014

SIGNA SA DE CVInactiveCAPECITABINE USP

DMF 305432016

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

Products (2)

Sort:

#001 — 150MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 5, 2024

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 5, 2024