NDC 15338-458

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 Apace Packaging, Llc. The primary component is Diltiazem Hydrochloride.

Product ID15338-458_6815a490-0925-53e8-e053-2a91aa0ae212
NDC15338-458
Product TypeHuman Prescription Drug
Proprietary NameDiltiazem Hydrochloride Extended Release
Generic NameDiltiazem Hydrochloride
Dosage FormCapsule, Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-08-18
Marketing CategoryANDA / ANDA
Application NumberANDA074984
Labeler NameApace Packaging, LLC
Substance NameDILTIAZEM HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 15338-458-09

90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (15338-458-09)
Marketing Start Date2016-08-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15338-458-09 [15338045809]

Diltiazem Hydrochloride Extended Release CAPSULE, COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074984
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DILTIAZEM HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:665e2beb-aa45-87c7-e053-2a91aa0a234c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 830845
  • 830861
  • 830801
  • 830837
    • UPC Code
  • 0342291330900
  • 0342291331907
  • 0342291328907
  • 0342291329904

    • 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
    68071-3079Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    68071-3199Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    68071-3398Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    68682-369Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    68682-370Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    68682-368Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    68682-371Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    68682-367Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    68682-372Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    70518-1009Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    70518-1993Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    71335-0839Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    15338-457Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    15338-458Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    15338-435Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    15338-434Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    35356-947Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    50090-0802Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    53808-0695Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    55154-4799Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    55154-4788Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    55154-4787Diltiazem Hydrochloride Extended ReleaseDiltiazem Hydrochloride Extended Release
    63629-7981Diltiazem Hydrochloride EXTENDED RELEASEDiltiazem Hydrochloride EXTENDED RELEASE
    71335-1585Diltiazem 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
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