NDC 0093-0321

Diltiazem Hydrochloride

Diltiazem Hydrochloride

Diltiazem Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Diltiazem Hydrochloride.

Product ID0093-0321_46e3236a-9660-4cdd-8a54-7284b1d4229f
NDC0093-0321
Product TypeHuman Prescription Drug
Proprietary NameDiltiazem Hydrochloride
Generic NameDiltiazem Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1995-12-26
Marketing CategoryANDA / ANDA
Application NumberANDA074185
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameDILTIAZEM HYDROCHLORIDE
Active Ingredient Strength120 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0093-0321-01

100 TABLET, FILM COATED in 1 BOTTLE (0093-0321-01)
Marketing Start Date1995-12-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-0321-01 [00093032101]

Diltiazem Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-12-26

NDC 0093-0321-05 [00093032105]

Diltiazem Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074185
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-04
Marketing End Date2011-01-06

NDC 0093-0321-10 [00093032110]

Diltiazem Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074185
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-04
Marketing End Date2011-01-06

Drug Details

Active Ingredients

IngredientStrength
DILTIAZEM HYDROCHLORIDE120 mg/1

OpenFDA Data

SPL SET ID:69ca7cae-fdf3-413a-900b-95cf6e9e7b63
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 831103
  • 831054
  • 833217
  • 831102

    • Pharmacological Class

    • Calcium Channel Antagonists [MoA]
    • Calcium Channel Blocker [EPC]

    NDC Crossover Matching brand name "Diltiazem Hydrochloride" or generic name "Diltiazem Hydrochloride"

    NDCBrand NameGeneric Name
    0093-0318Diltiazem HydrochlorideDiltiazem Hydrochloride
    0093-0319Diltiazem HydrochlorideDiltiazem Hydrochloride
    0093-0320Diltiazem HydrochlorideDiltiazem Hydrochloride
    0093-0321Diltiazem HydrochlorideDiltiazem Hydrochloride
    0409-4350Diltiazem HydrochlorideDiltiazem Hydrochloride
    68071-1914Diltiazem HydrochlorideDiltiazem Hydrochloride
    68071-1928Diltiazem HydrochlorideDiltiazem Hydrochloride
    68071-1925Diltiazem HydrochlorideDiltiazem Hydrochloride
    68071-3290Diltiazem HydrochlorideDiltiazem Hydrochloride
    68071-4005Diltiazem HydrochlorideDiltiazem Hydrochloride
    68071-4155Diltiazem HydrochlorideDiltiazem Hydrochloride
    68071-4371Diltiazem HydrochlorideDiltiazem Hydrochloride
    68071-4242Diltiazem HydrochlorideDiltiazem Hydrochloride
    68071-4591Diltiazem HydrochlorideDiltiazem Hydrochloride
    68071-4664Diltiazem HydrochlorideDiltiazem Hydrochloride
    68151-2113diltiazem hydrochloridediltiazem hydrochloride
    68151-2111diltiazem hydrochloridediltiazem hydrochloride
    68151-2114diltiazem hydrochloridediltiazem hydrochloride
    68151-1480diltiazem hydrochloridediltiazem hydrochloride
    68151-2886Diltiazem HydrochlorideDiltiazem Hydrochloride
    68151-2112diltiazem hydrochloridediltiazem hydrochloride
    68258-6024Diltiazem HydrochlorideDiltiazem Hydrochloride
    68258-6046Diltiazem HydrochlorideDiltiazem Hydrochloride
    68382-595diltiazem hydrochloridediltiazem hydrochloride
    68382-596diltiazem hydrochloridediltiazem hydrochloride
    68382-598diltiazem hydrochloridediltiazem hydrochloride
    68382-599diltiazem hydrochloridediltiazem hydrochloride
    68382-597diltiazem hydrochloridediltiazem hydrochloride
    68682-705Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-006Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-997Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-007Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-708Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-994Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-009Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-706Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-707Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-998Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-709Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-008Diltiazem HydrochlorideDiltiazem Hydrochloride
    68682-993Diltiazem HydrochlorideDiltiazem Hydrochloride
    68788-6893Diltiazem HydrochlorideDiltiazem Hydrochloride
    70518-0040Diltiazem HydrochlorideDiltiazem Hydrochloride
    70518-0109Diltiazem HydrochlorideDiltiazem Hydrochloride
    70518-0820Diltiazem HydrochlorideDiltiazem Hydrochloride
    70518-0783Diltiazem HydrochlorideDiltiazem Hydrochloride
    70518-1096Diltiazem HydrochlorideDiltiazem Hydrochloride
    70771-1034diltiazem hydrochloridediltiazem hydrochloride
    70771-1033diltiazem hydrochloridediltiazem hydrochloride
    70771-1032diltiazem hydrochloridediltiazem hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.