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FDA Orange Book · active-ingredient family

Diltiazem hydrochloride

Diltiazem hydrochloride is approved as 11 brand and 59 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE · NDA 218038

11

Brand (NDA)

59

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, injectable, solution, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDERLD×2HQ SPCLT PHARMANDA 218038—Feb 21, 2025
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%RLD×2EXELA PHARMANDA 215252—Oct 28, 2021
CARDIZEM LARLD×6BAUSCHNDA 021392ABFeb 06, 2003
TIAZACRLD×6BAUSCHNDA 020401AB4Sep 11, 1995
CARDIZEM CDRLD×5BAUSCHNDA 020062AB3Aug 10, 1992
DILACOR XRRLD×3ALLERGANNDA 020092—May 29, 1992
CARDIZEMRLD×2BIOVAIL LABS INTLNDA 020027—Oct 24, 1991
CARDIZEM SRRLD×4BIOVAILNDA 019471—Jan 23, 1989
CARDIZEMRLD×4BAUSCHNDA 018602ABNov 05, 1982
DILTIAZEM HYDROCHLORIDE×6BIOVAILNDA 020939—Jan 28, 2000
CARDIZEMBIOVAILNDA 020792—Sep 05, 1997

Generic (ANDA) products (59)

ProductApplicantApplicationTEApproved
DILTIAZEM HYDROCHLORIDE×5MACLEODS PHARMS LTDANDA 218744AB3Feb 27, 2026
DILTIAZEM HYDROCHLORIDE×4ALEMBICANDA 217633ABNov 14, 2025
DILTIAZEM HYDROCHLORIDE×4ZYDUS LIFESCIENCESANDA 219253ABAug 08, 2025
DILTIAZEM HYDROCHLORIDE×3NOVAST LABSANDA 218032AB1Jul 02, 2025
DILTIAZEM HYDROCHLORIDE×3UTOPIC PHARMSANDA 219073AB1Mar 24, 2025
DILTIAZEM HYDROCHLORIDE×5ALEMBICANDA 216968AB3Nov 08, 2024
DILTIAZEM HYDROCHLORIDE×3ALEMBICANDA 218587AB2Oct 18, 2024
DILTIAZEM HYDROCHLORIDE×6SCIEGEN PHARMSANDA 216327ABApr 06, 2023
DILTIAZEM HYDROCHLORIDEEUGIA PHARMAANDA 216552—Mar 29, 2023
DILTIAZEM HYDROCHLORIDE×6AMTAANDA 216439ABMar 07, 2023
DILTIAZEM HYDROCHLORIDE×3TWI PHARMSANDA 217377AB1Mar 01, 2023
DILTIAZEM HYDROCHLORIDE×4SCIEGEN PHARMSANDA 216521ABSep 23, 2022
DILTIAZEM HYDROCHLORIDE×3UTOPIC PHARMSANDA 216304AB2Aug 08, 2022
DILTIAZEM HYDROCHLORIDE×3DR REDDYS LABS SAANDA 215775AB1May 05, 2022
DILTIAZEM HYDROCHLORIDE×3GLENMARK PHARMS LTDANDA 212317AB1Mar 22, 2021
DILTIAZEM HYDROCHLORIDE×3ACCORD HLTHCAREANDA 206997AB2Apr 28, 2020
DILTIAZEM HYDROCHLORIDE×4EDENBRIDGE PHARMSANDA 211596—Nov 18, 2019
DILTIAZEM HYDROCHLORIDE×5NOVAST LABSANDA 208783AB3Jun 14, 2019
DILTIAZEM HYDROCHLORIDE×5TWI PHARMSANDA 205231AB3Aug 30, 2018
DILTIAZEM HYDROCHLORIDEPH HEALTHANDA 209766—May 30, 2018
DILTIAZEM HYDROCHLORIDE×6ZYDUS PHARMSANDA 206641AB4Aug 11, 2017
DILTIAZEM HYDROCHLORIDE×5ZYDUS PHARMSANDA 206534AB3Aug 08, 2017
DILTIAZEM HYDROCHLORIDE×5SUN PHARMANDA 203023—Jun 08, 2017
DILTIAZEM HYDROCHLORIDEACTAVIS ELIZABETHANDA 202463AB3Dec 07, 2012
DILTIAZEM HYDROCHLORIDE×6CHARTWELL RXANDA 091022AB4Sep 28, 2012
DILTIAZEM HYDROCHLORIDEHIKMA FARMACEUTICAANDA 202651—Aug 09, 2012
DILTIAZEM HYDROCHLORIDE×5SUN PHARMANDA 090492—Oct 28, 2011
DILTIAZEM HYDROCHLORIDE×5SUN PHARMANDA 090421—Nov 15, 2010
DILTIAZEM HYDROCHLORIDE×6ACTAVIS LABS FL INCANDA 077686ABMar 15, 2010
DILTIAZEM HYDROCHLORIDEHIKMAANDA 078538APDec 17, 2008
DILTIAZEM HYDROCHLORIDE×6NESHER PHARMSANDA 076563—Sep 12, 2006
DILTZAC×5APOTEXANDA 076395—Feb 01, 2006
DILT-CD×4APOTEXANDA 076151—May 20, 2004
TAZTIA XT×5ACTAVIS LABS FL INCANDA 075401—Apr 10, 2003
DILTIAZEM HYDROCHLORIDEHOSPIRAANDA 075853—Dec 17, 2002
DILTIAZEM HYDROCHLORIDEINTL MEDICATIONANDA 075749—Nov 21, 2001
DILTIAZEM HYDROCHLORIDE×3APOTEXANDA 074943AB2Dec 19, 2000
DILTIAZEM HYDROCHLORIDEHOSPIRAANDA 075004—Feb 16, 2000
DILTIAZEM HYDROCHLORIDE×4VALEANT PHARMS NORTHANDA 075116AB3Dec 23, 1999
DILTIAZEM HYDROCHLORIDE×4PH HEALTHANDA 074984AB3Dec 20, 1999
DILTIAZEM HYDROCHLORIDEMYLAN LABS LTDANDA 075375—Sep 30, 1999
DILTIAZEM HYDROCHLORIDE×3BIOVAILANDA 074845—Sep 15, 1999
DILTIAZEM HYDROCHLORIDEHOSPIRAANDA 075106—Apr 29, 1999
CARTIA XT×4ACTAVIS LABS FL INCANDA 074752AB3Jul 09, 1998
DILTIAZEM HYDROCHLORIDEHOSPIRAANDA 074941—Apr 15, 1998
DILTIAZEM HYDROCHLORIDERISINGANDA 075086APApr 09, 1998
DILTIAZEM HYDROCHLORIDE×3PHARMOBEDIENTANDA 075124—Mar 18, 1998
DILTIAZEM HYDROCHLORIDE×3ACTAVIS LABS FL INCANDA 074852—Oct 10, 1997
DILTIAZEM HYDROCHLORIDEDR REDDYSANDA 074894—Aug 26, 1997
DILTIAZEM HYDROCHLORIDE×3MYLANANDA 074910AB1May 02, 1997
DILTIAZEM HYDROCHLORIDESAGENTANDA 074617APFeb 28, 1996
DILTIAZEM HYDROCHLORIDE×4TEVAANDA 074185ABMay 31, 1995
DILTIAZEM HYDROCHLORIDE×4IVAX SUB TEVA PHARMSANDA 074168—Mar 03, 1995
DILTIAZEM HYDROCHLORIDE×2TEVAANDA 074084—Feb 25, 1994
DILTIAZEM HYDROCHLORIDE×3TEVAANDA 074079—Nov 30, 1993
DILTIAZEM HYDROCHLORIDE×4APOTHECONANDA 074051—Mar 31, 1993
DILTIAZEM HYDROCHLORIDE×4CHARTWELL MOLECULESANDA 074093—Nov 05, 1992
DILTIAZEM HYDROCHLORIDE×4RISINGANDA 072838—Nov 05, 1992
DILTIAZEM HYDROCHLORIDE×4TEVA PHARMSANDA 074067—Nov 05, 1992

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Diltiazem hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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