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DILTIAZEM HYDROCHLORIDE

ANDA

DILTIAZEM HYDROCHLORIDE | A206534 | ZYDUS PHARMACEUTICALS USA INC

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CARDIZEM CD(TE code: AB3)

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.3504

per ea

Lowest NADAC/Unit

$0.1436

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68382059916DILTIAZEM 24H ER(CD) 360 MG CP	$0.3504	EA	Generic	—	2026-06-17
68382059805DILTIAZEM 24H ER(CD) 300 MG CP	$0.2983	EA	Generic	—	2026-06-17
68382059816DILTIAZEM 24H ER(CD) 300 MG CP	$0.2983	EA	Generic	—	2026-06-17
68382059705DILTIAZEM 24H ER(CD) 240 MG CP	$0.1903	EA	Generic	—	2026-06-17
68382059716DILTIAZEM 24H ER(CD) 240 MG CP	$0.1903	EA	Generic	—	2026-06-17
68382059616DILTIAZEM 24H ER(CD) 180 MG CP	$0.1808	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 Chain7 active DMFs12 inactive

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

LUSOCHIMICA SPADILTIAZEM HYDROCHLORIDE

DMF 66861986

TAPI NL BVDILTIAZEM HYDROCHLORIDE USP

DMF 72391987

FIS FABBRICA ITALIANA SINTETICI SPADILTIAZEM HYDROCHLORIDE

DMF 76001988

PIRAMAL PHARMA LTDDILTIAZEM HYDROCHLORIDE USP

DMF 147132000

DIVIS LABORATORIES LTDDILTIAZEM HYDROCHLORIDE USP

DMF 152672001

CHEMECA DRUGS PRIVATE LTDDILTIAZEM HYDROCHLORIDE USP

DMF 342202020

VASUDHA PHARMA CHEM LTDDILTIAZEM HYDROCHLORIDE USP

DMF 407222024

TORCAN CHEMICAL LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 72401987

PCASInactiveDILTIAZEM HYDROCHLORIDE

DMF 77561988

FABBRICA ITALIANA SINTETICI SPAInactiveDILTIAZEM HYDROCHLORIDE

DMF 79081989

HAMARI CO LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 85481990

ICHIKAWA LAB CO LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 87061990

TATEISHI SEIYAKU CO LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 87991990

MITSUBISHI TANABE PHARMA CORPInactiveDILTIAZEM HYDROCHLORIDE (PROCESS C)

DMF 103811993

SUMITRA PHARMACEUTICALS AND CHEMICALS LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 104661993

DR REDDYS LABORATORIES LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 115041995

NATCO PHARMA LTDInactiveDILTIAZEM HYDROCHLORIDE, USP

DMF 131301998

SYN-TECH CHEM AND PHARM CO LTDInactiveDILTIAZEM HYDROCHLORIDE USP

DMF 146592000

FARMAK ASInactiveDILTIAZEM HYDROCHLORIDE

DMF 154182001

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 15, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 120MG

AB3

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