NDC 68382-750

TIADYLT ER

Diltiazem Hydrochloride

TIADYLT ER is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Diltiazem Hydrochloride.

Product ID68382-750_321f0bdc-5629-40fb-8211-e5b379039e59
NDC68382-750
Product TypeHuman Prescription Drug
Proprietary NameTIADYLT ER
Generic NameDiltiazem Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-11-08
Marketing CategoryANDA / ANDA
Application NumberANDA206641
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameDILTIAZEM HYDROCHLORIDE
Active Ingredient Strength420 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68382-750-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-750-01)
Marketing Start Date2017-11-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-750-01 [68382075001]

TIADYLT ER CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206641
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-08

NDC 68382-750-10 [68382075010]

TIADYLT ER CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206641
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-08

NDC 68382-750-06 [68382075006]

TIADYLT ER CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206641
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-08

NDC 68382-750-05 [68382075005]

TIADYLT ER CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206641
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-08

NDC 68382-750-16 [68382075016]

TIADYLT ER CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206641
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-08

Drug Details

Active Ingredients

IngredientStrength
DILTIAZEM HYDROCHLORIDE420 mg/1

OpenFDA Data

SPL SET ID:1278cd76-b8e9-42d9-ad19-6858e72cf9f2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 830861
  • 830795
  • 1988330
  • 1988324
  • 1988319
  • 1988316
  • 830801
  • 830837
  • 1988311
  • 1988308
  • 831359
  • 830845
    • UPC Code
  • 0368382746160
  • 0368382749161
  • 0368382745163
  • 0368382750167
  • 0368382748164
  • 0368382747167

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68382-750TIADYLT ERTIADYLT ER
    68382-745TIADYLT ERTIADYLT ER
    68382-746TIADYLT ERTIADYLT ER
    68382-749TIADYLT ERTIADYLT ER
    68382-747TIADYLT ERTIADYLT ER
    68382-748TIADYLT ERTIADYLT ER
    70771-1037TIADYLT ERTIADYLT ER
    70771-1036TIADYLT ERTIADYLT ER
    70771-1039TIADYLT ERTIADYLT ER
    70771-1040TIADYLT ERTIADYLT ER
    70771-1035TIADYLT ERTIADYLT ER
    70771-1038TIADYLT ERTIADYLT ER
    0187-0771CardizemDiltiazem Hydrochloride
    0187-0772CardizemDiltiazem Hydrochloride
    0187-0792CardizemDiltiazem Hydrochloride
    0187-0795Cardizem CDdiltiazem hydrochloride
    0187-0796Cardizem CDdiltiazem hydrochloride
    0187-0797Cardizem CDdiltiazem hydrochloride
    0093-0318Diltiazem HydrochlorideDiltiazem Hydrochloride
    0093-0319Diltiazem HydrochlorideDiltiazem Hydrochloride
    0093-0320Diltiazem HydrochlorideDiltiazem Hydrochloride
    0093-0321Diltiazem HydrochlorideDiltiazem Hydrochloride
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