diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 120 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8379
Product ID 0615-8379_72f92a1f-d8d6-494e-a8e9-875ca4bf4b50
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208783
Listing Expiration 2026-12-31
Marketing Start 2019-06-14

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158379
Hyphenated Format 0615-8379

Supplemental Identifiers

RxCUI
830837 830845 830861
UNII
OLH94387TE

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diltiazem hydrochloride (source: ndc)
Generic Name diltiazem hydrochloride (source: ndc)
Application Number ANDA208783 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8379-39)
source: ndc

Packages (1)

0615-8379-39 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8379-39)

Ingredients (1)

diltiazem hydrochloride (120 mg/1)

Linked Drug Pages (1)

diltiazem hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "72f92a1f-d8d6-494e-a8e9-875ca4bf4b50", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830837", "830845", "830861"], "spl_set_id": ["70f167a1-ec7f-4969-b446-166af3e52c05"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8379-39)", "package_ndc": "0615-8379-39", "marketing_start_date": "20210209"}], "brand_name": "diltiazem hydrochloride", "product_id": "0615-8379_72f92a1f-d8d6-494e-a8e9-875ca4bf4b50", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "0615-8379", "generic_name": "diltiazem hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "diltiazem hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA208783", "marketing_category": "ANDA", "marketing_start_date": "20190614", "listing_expiration_date": "20261231"}