diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler actavis pharma, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 360 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-2918
Product ID 0228-2918_3bfa9909-89ed-47d3-8e01-0c688a59a093
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202463
Listing Expiration 2026-12-31
Marketing Start 2013-11-25

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 02282918
Hyphenated Format 0228-2918

Supplemental Identifiers

RxCUI
830795
UNII
OLH94387TE

Packaging Origin

Original Packager
true

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 ANDA202463 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 360 mg/1
source: ndc
Packaging
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2918-09)
source: ndc

Packages (1)

Ingredients (1)

diltiazem hydrochloride (360 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3bfa9909-89ed-47d3-8e01-0c688a59a093", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830795"], "spl_set_id": ["178eec1f-1d4d-4a38-b66a-d3ba3de06c3d"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2918-09)", "package_ndc": "0228-2918-09", "marketing_start_date": "20131125"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "0228-2918_3bfa9909-89ed-47d3-8e01-0c688a59a093", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "0228-2918", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "360 mg/1"}], "application_number": "ANDA202463", "marketing_category": "ANDA", "marketing_start_date": "20131125", "listing_expiration_date": "20261231"}