Marplan
NDC Package 30698-032-01

11-digit billing NDC: 30698003201 · Billing unit: EA · 100 EA per package

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Marplan is indicated for the treatment of depression. Marketed by Validus Pharmaceuticals Llc, this product is identified by NDC 30698-032 and is authorized under FDA application NDA011961.

Identification & Billing

NDC Package Code
30698-032-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
30698003201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Marplan
Dosage Form
-
Usage Information
Marplan is indicated for the treatment of depression. Because of its potentially serious side effects, Marplan is not an antidepressant of first choice in the treatment of newly diagnosed depressed patients.The efficacy of Marplan in the treatment of depression was established in 6-week controlled trials of depressed outpatients.  These patients had symptoms that corresponded to the DSM-IV category of major depressive disorder; however, they often also had signs and symptoms of anxiety (anxious mood, panic, and/or phobic symptoms) (see CLINICAL PHARMACOLOGY).A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The antidepressant effectiveness of Marplan in hospitalized depressed patients, or in endogenomorphically retarded and delusionally depressed patients, has not been adequately studied.The effectiveness of Marplan in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials.  Therefore, the physician who elects to use Marplan for extended periods should periodically evaluate the long-term usefulness of the drug for the individual patient.

Regulatory & Marketing

Labeler Name
Validus Pharmaceuticals Llc
FDA Application #
NDA011961
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-1959
Listing Expiration
12-31-2024
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 30698-032-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Marplan, labeled by Validus Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Validus Pharmaceuticals Llc on July 01, 1959. The current certification is valid through December 31, 2024.

How is this Validus Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 30698003201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
30698-032-01
11-Digit CMS (5-4-2)
30698-0032-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.