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 TABLET
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 30 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1492
Product ID 67046-1492_2cd90eaf-cc66-7b68-e063-6294a90a9737
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216521
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

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 670461492
Hyphenated Format 67046-1492

Supplemental Identifiers

RxCUI
833217
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 ANDA216521 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1492-3)
source: ndc

Packages (1)

67046-1492-3 30 TABLET in 1 BLISTER PACK (67046-1492-3)

Ingredients (1)

diltiazem hydrochloride (30 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": "2cd90eaf-cc66-7b68-e063-6294a90a9737", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["833217"], "spl_set_id": ["2cd92b83-075e-b069-e063-6294a90a9fff"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1492-3)", "package_ndc": "67046-1492-3", "marketing_start_date": "20250129"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "67046-1492_2cd90eaf-cc66-7b68-e063-6294a90a9737", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "67046-1492", "generic_name": "Diltiazem hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA216521", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}