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Active ingredient

Diltiazem

299 finished FDA listings contain Diltiazem as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DILTIAZEM HCL, DILTIAZEM HYDROCHLORIDE
Dosage forms
Capsule, Coated, Extended Release, Capsule, Extended Release, Injection, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Tablet, Tablet, Coated, Tablet, Extended Release, Tablet, Film Coated
Routes
Intravenous, Oral
Manufacturers / labelers
54
Strengths listed
1 mg/ml · 100 mg/1 · 120 mg/1 · 180 mg/1 · 240 mg/1 · 30 mg/1 · 300 mg/1 · 360 mg/1 · 420 mg/1 · 5 mg/ml · 60 mg/1 · 90 mg/1
Brand names in FDA listings
Cardizem, Cardizem Cd, Cardizem La, Cartia Xt, Diltiazem Hydrochloride, Diltiazem Hydrochloride Extended Release, Diltiazem Hydrochloride Extended-Release, Diltiazem Hydrochloride In Sodium Chloride, Matzim La, Tiadylt Er, Tiazac Extended Release

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3443

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 018602BAUSCH1982-11-059
NDA 020062BAUSCH1991-12-275
ANDA 074093CHARTWELL MOLECULES1992-11-054
ANDA 074185TEVA1995-05-3112
NDA 020401BAUSCH1995-09-1115
ANDA 074617SAGENT1996-02-284
ANDA 074910MYLAN1997-05-0210
ANDA 074752ACTAVIS LABS FL INC1998-07-097
ANDA 074943APOTEX1998-08-067
ANDA 074984PH HEALTH1999-12-2013
ANDA 075116VALEANT PHARMS NORTH1999-12-2311
ANDA 075853HOSPIRA2002-12-172
NDA 021392BAUSCH2003-02-0612
ANDA 078538HIKMA2008-12-178
ANDA 077686ACTAVIS LABS FL INC2010-03-155
ANDA 090421SUN PHARM2010-11-155
ANDA 090492SUN PHARM2011-10-285
ANDA 202463ACTAVIS ELIZABETH2012-12-071
ANDA 203023SUN PHARM2017-06-086
ANDA 206534ZYDUS PHARMS2017-08-0811
ANDA 206641ZYDUS PHARMS2017-08-1113
ANDA 205231TWI PHARMS2018-08-3021
ANDA 208783NOVAST LABS2019-06-1421
ANDA 206997ACCORD HLTHCARE2020-04-283
ANDA 212317GLENMARK PHARMS LTD2021-03-223
ANDA 215775DR REDDYS LABS SA2022-05-056
ANDA 216304UTOPIC PHARMS2022-08-083
ANDA 216521SCIEGEN PHARMS2022-09-2311
ANDA 217377TWI PHARMS2023-03-013
ANDA 216439AMTA2023-03-076
ANDA 216552EUGIA PHARMA2023-03-293
ANDA 216327SCIEGEN PHARMS2023-04-0612
ANDA 218587ALEMBIC2024-10-186
ANDA 216968ALEMBIC2024-11-0810
NDA 218038HQ SPCLT PHARMA2025-02-212
ANDA 218032NOVAST LABS2025-07-023
ANDA 219253ZYDUS LIFESCIENCES2025-08-088
ANDA 217633ALEMBIC2025-11-148
ANDA 218744MACLEODS PHARMS2026-02-275

Official labeling on DailyMed

Showing the 12 most recent of 114 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.