Viewing data from:

LORATADINE

ANDA

LORATADINE | A210088 | SUN PHARMACEUTICAL INDUSTRIES LTD

2 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.5236

per ea

Lowest NADAC/Unit

$0.5236

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
51660011231CHILD LORATADINE 5 MG TAB CHEW	$0.5236	EA	Generic	—	2026-06-17

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

API Supply Chain12 active DMFs12 inactive

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

QUIMICA SINTETICA SALORATADINE

DMF 118031995

MOREPEN LABORATORIES LTDLORATADINE

DMF 126501997

ROLABO OUTSOURCING SLLORATADINE USP

DMF 141551999

SUN PHARMACEUTICAL INDUSTRIES LTDLORATADINE USP

DMF 152512001

CADILA PHARMACEUTICALS LTDLORATADINE USP POWDER

DMF 175822004

ZYDUS LIFESCIENCES LTDLORATADINE USP

DMF 187022005

ALIVUS LIFE SCIENCES LTDLORATADINE USP

DMF 194002006

VASUDHA PHARMA CHEM LTDLORATADINE USP

DMF 203672007

MATRIX PHARMACORP PRIVATE LTDLORATADINE USP (LCP)

DMF 204472007

MOREPEN LABORATORIES LTDLORATADINE (PROCESS 2) U.S.P.

DMF 206692007

SOLARA ACTIVE PHARMA SCIENCES LTDLORATADINE USP

DMF 284112014

VASUDHA PHARMA CHEM LTDLORATADINE USP (PROCESS-II)

DMF 348222020

MSD INTERNATIONAL GMBHInactiveLORATADINE

DMF 66261986

QUIMICA SINTETICA SAInactiveLORATADINE

DMF 98301992

MSD INTERNATIONAL GMBHInactiveLORATADINE

DMF 130321998

INKE SAInactiveLORATADINE

DMF 138111998

MEDICHEM SAInactiveLORATADINE

DMF 138421998

CADILA HEALTHCARE LTDInactiveLORATADINE

DMF 169702003

MYLAN LABORATORIES LTDInactiveLORATADINE USP (LDP)

DMF 172872004

DIVIS LABORATORIES LTDInactiveLORATADINE USP

DMF 178102004

SUZHOU WANQING PHARMACEUTICALS CO LTDInactiveLORATADINE

DMF 180582005

CATALENT PHARMA SOLUTIONS LLCInactiveLORATADINE SOFTGELS (10 MG)

DMF 186962005

ZHEJIANG WEPON PHARMACEUTICAL CO LTDInactiveLORATADINE

DMF 197402006

AARTI DRUGS LTDInactiveLORATADINE

DMF 204962007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 11, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Apr 16, 2018

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET, CHEWABLE;ORAL | Approved: Apr 25, 2025