diltiazem hydrochloride

Generic: diltiazem hydrochloride

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

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler hospira, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

diltiazem hydrochloride 100 mg/1

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-4350
Product ID 0409-4350_18648c0d-5f60-4195-92f0-1dffc1452d4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075853
Listing Expiration 2026-12-31
Marketing Start 2005-04-30

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04094350
Hyphenated Format 0409-4350

Supplemental Identifiers

RxCUI
1791230 1791240
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 ANDA075853 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-4350-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-4350-13)
source: ndc

Packages (1)

0409-4350-03 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-4350-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-4350-13)

Ingredients (1)

diltiazem hydrochloride (100 mg/1)

Linked Drug Pages (1)

Diltiazem Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "18648c0d-5f60-4195-92f0-1dffc1452d4c", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["1791230", "1791240"], "spl_set_id": ["bba03666-ff4f-4bf6-fa92-78e1ec2d9073"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-4350-03)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-4350-13)", "package_ndc": "0409-4350-03", "marketing_start_date": "20050430"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "0409-4350_18648c0d-5f60-4195-92f0-1dffc1452d4c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]"], "product_ndc": "0409-4350", "generic_name": "DILTIAZEM HYDROCHLORIDE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA075853", "marketing_category": "ANDA", "marketing_start_date": "20050430", "listing_expiration_date": "20261231"}