NDC 70771-1035

TIADYLT ER

Diltiazem Hydrochloride

TIADYLT ER is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Diltiazem Hydrochloride.

Product ID70771-1035_0ba81f83-4179-4aa6-8e91-605fdc918f37
NDC70771-1035
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 NameCadila Healthcare Limited
Substance NameDILTIAZEM HYDROCHLORIDE
Active Ingredient Strength120 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70771-1035-0

1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1035-0)
Marketing Start Date2017-11-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1035-9 [70771103509]

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

NDC 70771-1035-5 [70771103505]

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

NDC 70771-1035-1 [70771103501]

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

NDC 70771-1035-3 [70771103503]

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

NDC 70771-1035-0 [70771103500]

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

Drug Details

Active Ingredients

IngredientStrength
DILTIAZEM HYDROCHLORIDE120 mg/1

OpenFDA Data

SPL SET ID:d88e3546-3984-4dc9-893a-a29e95804550
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 830861
  • 830795
  • 1988330
  • 1988324
  • 1988319
  • 1988316
  • 830801
  • 830837
  • 1988311
  • 1988308
  • 831359
  • 830845
  • UPC Code
  • 0370771103591
  • 0370771103997
  • 0370771103898
  • 0370771103690
  • 0370771104093
  • 0370771103799
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.