Imipramine Hydrochloride Tablet, Film Coated
NDC Package 70868-810-10

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. 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. This formulation utilizes a tablet, film coated delivery system. Marketed by Key Therapeutics, this product is identified by NDC 70868-810 and is authorized under FDA application ANDA040751.

Identification & Billing

NDC Package Code
70868-810-10
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
70868-810
11-Digit Billing Format
70868081010
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
Imipramine Hydrochloride
Non-Proprietary Name
Imipramine Hydrochloride
Substance Name
Imipramine Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
IMIPRAMINE HYDROCHLORIDE 25 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
Key Therapeutics
Product Type
Human Prescription Drug
FDA Application #
ANDA040751
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-18-2022
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 70868-810-10 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Imipramine Hydrochloride, a human prescription drug labeled by Key Therapeutics. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet, film coated 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 Key Therapeutics on July 18, 2022. The current certification is valid through December 31, 2026.

How is this Key Therapeutics product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70868081010. 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)
70868-810-10
11-Digit CMS (5-4-2)
70868-0810-10

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