Imipramine Hydrochloride
NDC Package 50090-0035-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Imipramine Hydrochloride is the concomitant use of monoamine oxidase inhibiting compounds is contraindicated. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-0035 and is authorized under FDA application ANDA081049.

Identification & Billing

NDC Package Code
50090-0035-0
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
50090-0035
11-Digit Billing Format
50090003500
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imipramine Hydrochloride
Dosage Form
-
Usage Information
The concomitant use of monoamine oxidase inhibiting compounds is contraindicated. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. The potentiation of adverse effects can be serious, or even fatal. When it is desired to substitute imipramine hydrochloride in patients receiving a monoamine oxidase inhibitor, as long an interval should elapse as the clinical situation will allow, with a minimum of 14 days. Initial dosage should be low and increases should be gradual and cautiously prescribed.The drug is contraindicated during the acute recovery period after a myocardial infarction. Patients with a known hypersensitivity to this compound should not be given the drug. The possibility of cross-sensitivity to other dibenzazepine compounds should be kept in mind.

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
FDA Application #
ANDA081049
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-05-1990
Listing Expiration
12-31-2019
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 50090-0035-0 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Imipramine Hydrochloride, labeled by A-s Medication Solutions. 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 A-s Medication Solutions on June 05, 1990. The current certification is valid through December 31, 2019.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090003500. 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 (5-4-1)
50090-0035-0
11-Digit CMS (5-4-2)
50090-0035-00

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