diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler coupler llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 120 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1481
Product ID 67046-1481_2ced5dc5-47e0-1b71-e063-6394a90a0e3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074910
Listing Expiration 2026-12-31
Marketing Start 2025-01-30

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 670461481
Hyphenated Format 67046-1481

Supplemental Identifiers

RxCUI
830872
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 ANDA074910 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1481-3)
source: ndc

Packages (1)

67046-1481-3 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1481-3)

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": "2ced5dc5-47e0-1b71-e063-6394a90a0e3d", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830872"], "spl_set_id": ["2ced821f-19a6-4c7e-e063-6394a90adb80"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1481-3)", "package_ndc": "67046-1481-3", "marketing_start_date": "20250130"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "67046-1481_2ced5dc5-47e0-1b71-e063-6394a90a0e3d", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "67046-1481", "generic_name": "diltiazem hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA074910", "marketing_category": "ANDA", "marketing_start_date": "20250130", "listing_expiration_date": "20261231"}