diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

diltiazem hydrochloride 5 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-427
Product ID 55150-427_cb4e6bde-c44b-4e66-b565-cf955d311756
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216552
Listing Expiration 2026-12-31
Marketing Start 2023-03-29

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 55150427
Hyphenated Format 55150-427

Supplemental Identifiers

RxCUI
1791229 1791232 1791233
UPC
0355150427017 0355150426010
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 ANDA216552 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-427-10) / 25 mL in 1 VIAL, SINGLE-DOSE (55150-427-01)
source: ndc

Packages (1)

55150-427-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-427-10) / 25 mL in 1 VIAL, SINGLE-DOSE (55150-427-01)

Ingredients (1)

diltiazem hydrochloride (5 mg/mL)

Linked Drug Pages (1)

DILTIAZEM HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "cb4e6bde-c44b-4e66-b565-cf955d311756", "openfda": {"upc": ["0355150427017", "0355150426010"], "unii": ["OLH94387TE"], "rxcui": ["1791229", "1791232", "1791233"], "spl_set_id": ["f8d962ab-6cd4-43a1-a8fa-fb6548ac2a08"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-427-10)  / 25 mL in 1 VIAL, SINGLE-DOSE (55150-427-01)", "package_ndc": "55150-427-10", "marketing_start_date": "20230329"}], "brand_name": "DILTIAZEM HYDROCHLORIDE", "product_id": "55150-427_cb4e6bde-c44b-4e66-b565-cf955d311756", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "55150-427", "generic_name": "diltiazem hydrochloride", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DILTIAZEM HYDROCHLORIDE", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA216552", "marketing_category": "ANDA", "marketing_start_date": "20230329", "listing_expiration_date": "20261231"}