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DILUENT

water solution · Injection

Prescription ANDA TE AP

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

DILUENT

Generic name

water solution

Dosage form

Injection

Route

Intravenous

Marketing category

ANDA · ANDA

Labeler

Sandoz Inc

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
Sodium Chloride	4.5 mg/.5mL	707251	View
Water	1 mL/mL	1053154	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Injection

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
Increased Large Intestinal Motility [PE]	PE	All 83 members
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]	PE	All 83 members
Osmotic Activity [MoA]	MoA	All 105 members
Osmotic Laxative [EPC]	EPC	All 103 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

203649

Application type

ANDA · Abbreviated New Drug Application

Approval date

November 30, 2017

Sponsor

SANDOZ

Products on application

Submissions recorded

Products approved under application 203649.
Product	Trade name	Form	Ingredient	Status	TE
203649-001	TREPROSTINIL	INJECTABLE	TREPROSTINIL	Prescription	AP
203649-002	TREPROSTINIL	INJECTABLE	TREPROSTINIL	Prescription	AP
203649-003	TREPROSTINIL	INJECTABLE	TREPROSTINIL	Prescription	AP
203649-004	TREPROSTINIL	INJECTABLE	TREPROSTINIL	Prescription	AP

Therapeutic equivalence

Source: Orange Book

TE code

Reference Listed Drug

Reference Standard

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)

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 203649.
Type	No.	Action	Status	Date	Review
Supplement	10	Labeling	Approved	March 14, 2024	Standard
Supplement	5	Labeling	Approved	November 20, 2018	Standard
Supplement	4	Labeling	Approved	November 20, 2018	Standard
Supplement	2	Labeling	Approved	November 20, 2018	Standard
Supplement	1	Manufacturing (CMC)	Approved	April 18, 2018	Unknown
Original application	1		Approved	November 30, 2017	—

Review documents

0 · Original application · December 4, 2017
0 · Original application · November 4, 2014

Adverse event reports

Source: openFDA FAERS

271,787

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: SODIUM CHLORIDE. 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
0781-6021-94	0781-6021	Sandoz Inc	1 VIAL in 1 CARTON (0781-6021-94) / 50 mL in 1 VIAL	March 25, 2019
49281-912-05	49281-912	Sanofi Vaccines US Inc.	5 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-912-05) / .6 mL in 1 VIAL, SINGLE-DOSE (49281-912-59)	May 22, 1953
49281-912-10	49281-912	Sanofi Vaccines US Inc.	1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-912-10) / 3 mL in 1 VIAL, MULTI-DOSE (49281-912-69)	May 22, 1953
0781-6021	0781-6021	Sandoz Inc	—	March 25, 2019
49281-912	49281-912	Sanofi Vaccines US Inc.	—	May 22, 1953

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
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS	FDA	Adverse event report counts

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