NDC 0378-5280

Diltiazem Hydrochloride

Diltiazem Hydrochloride

Diltiazem Hydrochloride is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Diltiazem Hydrochloride.

Product ID0378-5280_5b423e90-e707-4e0b-9461-f982cce226cf
NDC0378-5280
Product TypeHuman Prescription Drug
Proprietary NameDiltiazem Hydrochloride
Generic NameDiltiazem Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date1998-03-24
Marketing CategoryANDA / ANDA
Application NumberANDA075124
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDILTIAZEM HYDROCHLORIDE
Active Ingredient Strength180 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-5280-05

500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5280-05)
Marketing Start Date1998-03-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5280-77 [00378528077]

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075124
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-03-24
Marketing End Date2017-11-28

NDC 0378-5280-01 [00378528001]

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075124
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-03-24
Marketing End Date2019-10-31

NDC 0378-5280-05 [00378528005]

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075124
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-03-24
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
DILTIAZEM HYDROCHLORIDE180 mg/1

OpenFDA Data

SPL SET ID:dc932468-b50b-474e-b11a-66fbf2fac206
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 830861
  • 830845
  • 830837
  • UPC Code
  • 0303785220770
  • 0303785280774
  • 0303785340775
  • 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

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