Imipramine Hydrochloride Tablet
NDC Package 68071-3669-9

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

Package Information

Imipramine Hydrochloride tablets is depression-For the relief of symptoms of depression. This formulation utilizes a tablet delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-3669 and is authorized under FDA application ANDA040751.

Identification & Billing

NDC Package Code
68071-3669-9
Package Description
90 TABLET in 1 BOTTLE
Product Code
68071-3669
11-Digit Billing Format
68071366909
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imipramine Hydrochloride
Non-Proprietary Name
Imipramine Hydrochloride
Substance Name
Imipramine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
IMIPRAMINE HYDROCHLORIDE 50 mg/1
Pharmacologic Class
Tricyclic Antidepressant - [EPC] (Established Pharmacologic Class)
Usage Information
Depression-For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis-May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040751
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2020
Listing Expiration
12-31-2026
Exclude Flag
N
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 68071-3669-9 identifies a specific commercial package of 90 tablet in 1 bottle of Imipramine Hydrochloride, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains imipramine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Nucare Pharmaceuticals, Inc. on August 01, 2020. The current certification is valid through December 31, 2026.

How is this Nucare Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071366909. 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)
68071-3669-9
11-Digit CMS (5-4-2)
68071-3669-09

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