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LABETALOL HYDROCHLORIDE

ANDA

LABETALOL HYDROCHLORIDE | A074787 | HERITAGE PHARMA LABS INC

4 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 9 NDCs

Highest NADAC/Unit

$0.2086

per ea

Lowest NADAC/Unit

$0.0843

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62135080060LABETALOL HCL 300 MG TABLET	$0.2086	EA	Generic	—	2026-06-17
23155072501LABETALOL HCL 300 MG TABLET	$0.2086	EA	Generic	—	2026-06-17
23155072505LABETALOL HCL 300 MG TABLET	$0.2086	EA	Generic	—	2026-06-17
23155072405LABETALOL HCL 200 MG TABLET	$0.1442	EA	Generic	—	2026-06-17
62135079260LABETALOL HCL 200 MG TABLET	$0.1442	EA	Generic	—	2026-06-17
23155072401LABETALOL HCL 200 MG TABLET	$0.1442	EA	Generic	—	2026-06-17

Showing 6 of 9 NDCs.

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

API Supply Chain13 active DMFs6 inactive

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

OLON SPALABETALOL HYDROCHLORIDE

DMF 117791995

CAMBREX PROFARMACO MILANO SRLLABETALOL HYDROCHLORIDE

DMF 127581997

COSMA SPALABETALOL HYDROCHLORIDE

DMF 147022000

FLAMMA SPALABETALOL HYDROCHLORIDE

DMF 163142002

SOLARA ACTIVE PHARMA SCIENCES LTDLABETALOL HYDROCHLORIDE

DMF 237102010

NEULAND LABORATORIES LTDLABETALOL HYDROCHLORIDE USP

DMF 305642016

UNICHEM LABORATORIES LTDLABETALOL HYDROCHLORIDE USP

DMF 315842017

SRINI PHARMACEUTICALS PRIVATE LTDLABETALOL HYDROCHLORIDE USP

DMF 340732019

MACLEODS PHARMACEUTICALS LTDLABETALOL HYDROCHLORIDE USP

DMF 340992020

PHLOW CORPLABETALOL HYDROCHLORIDE

DMF 352332021

VIYASH LIFE SCIENCES PRIVATE LTDLABETALOL HYDROCHLORIDE USP

DMF 373062022

ZYDUS LIFESCIENCES LTDLABETALOL HYDROCHLORIDE USP

DMF 378562022

ALIVUS LIFE SCIENCES LTDLABETALOL HYDROCHLORIDE USP

DMF 380642023

GLAXOCHEM LTDInactiveLABETALOL HYDROCHLORIDE

DMF 57151985

SIBEFAT SPAInactiveLABETALOL HYDROCHLORIDE

DMF 84951990

ERREGIERRE SPAInactiveLABETALOL HYDROCHLORIDE

DMF 99271992

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveLABETALOL HYDROCHLORIDE

DMF 109011994

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveLABETALOL HYDROCHLORIDE

DMF 173192004

MYLAN LABORATORIES LTDInactiveLABETALOL HYDROCHLORIDE USP

DMF 193662006

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 3, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 3, 1998

No patent or exclusivity listings for this strength.

#002 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 3, 1998

#003 — 300MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 3, 1998

#004 — 400MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 26, 2026