NDC 71335-1043

Diltiazem Hydrochloride Extended-Release

Diltiazem Hydrochloride

Diltiazem Hydrochloride Extended-Release is a Oral Capsule, Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Diltiazem Hydrochloride.

Product ID71335-1043_85cb9a52-834f-478d-a1a9-0726661d2525
NDC71335-1043
Product TypeHuman Prescription Drug
Proprietary NameDiltiazem Hydrochloride Extended-Release
Generic NameDiltiazem Hydrochloride
Dosage FormCapsule, Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA074984
Labeler NameBryant Ranch Prepack
Substance NameDILTIAZEM HYDROCHLORIDE
Active Ingredient Strength180 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71335-1043-1

30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1043-1)
Marketing Start Date2019-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1043-1 [71335104301]

Diltiazem Hydrochloride Extended-Release CAPSULE, COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074984
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-16

NDC 71335-1043-2 [71335104302]

Diltiazem Hydrochloride Extended-Release CAPSULE, COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074984
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-16

Drug Details

Active Ingredients

IngredientStrength
DILTIAZEM HYDROCHLORIDE180 mg/1

OpenFDA Data

SPL SET ID:74232d69-1a8c-449d-8e8e-85488e6cc8f8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 830845
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Diltiazem Hydrochloride Extended-Release" or generic name "Diltiazem Hydrochloride"

    NDCBrand NameGeneric Name
    68071-3076Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    68071-3214Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    68071-3264Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    68151-1457Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    68788-7237Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    70518-1062Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    70518-1017Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    71335-0009Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    71335-0745Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    71335-1063Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    71335-1043Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    10370-830Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    10370-832Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    10370-829Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    10370-831Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    42291-186Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    42291-185Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    42291-184Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    42291-187Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    50090-2593Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    50090-2870Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    50090-2884Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    60687-206Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    60687-195Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    60687-217Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    60687-228Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    63739-015Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    63739-014Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    63739-016Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    71335-1223Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    70518-2237Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    63629-8232Diltiazem Hydrochloride Extended-ReleaseDiltiazem Hydrochloride Extended-Release
    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.