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DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE

Diltiazem Hydrochloride · Injection, Solution

Prescription NDA RLD

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE

Generic name

Diltiazem Hydrochloride

Dosage form

Injection, Solution

Route

Intravenous

Marketing category

NDA · NDA

Labeler

WG Critical Care, LLC

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Diltiazem Hydrochloride	1 mg/mL	831054	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Injection, Solution

Route of administration

Intravenous

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Calcium Channel Antagonists [MoA]	MoA	All 75 members
Calcium Channel Blocker [EPC]	EPC	All 55 members
Cytochrome P450 3A4 Inhibitors [MoA]	MoA	All 118 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

218038

Application type

NDA · New Drug Application

Approval date

February 21, 2025

Sponsor

HQ SPCLT PHARMA

Products on application

Submissions recorded

Products approved under application 218038.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
218038-001	DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE	SOLUTION		DILTIAZEM HYDROCHLORIDE	Prescription	—	RLD RS
218038-002	DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE	SOLUTION		DILTIAZEM HYDROCHLORIDE	Prescription	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 218038.
Type	No.	Action	Status	Date	Review
Original application	1	Type 5 - New Formulation or New Manufacturer	Approved	February 21, 2025	Standard

Review documents

0 · Original application · November 17, 2025
0 · Original application · February 25, 2025
0 · Original application · February 24, 2025

Adverse event reports

Source: openFDA FAERS

34,216

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DILTIAZEM HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
44567-662-10	44567-662	WG Critical Care, LLC	10 BAG in 1 CARTON (44567-662-10) / 100 mL in 1 BAG (44567-662-01)	March 21, 2025
44567-663-10	44567-663	WG Critical Care, LLC	10 BAG in 1 CARTON (44567-663-10) / 250 mL in 1 BAG (44567-663-01)	March 21, 2025
44567-662	44567-662	WG Critical Care, LLC	—	March 21, 2025
44567-663	44567-663	WG Critical Care, LLC	—	March 21, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.