Estazolam Tablet
NDC Package 75907-028-01

11-digit billing NDC: 75907002801 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Estazolam tablets is estazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. This formulation utilizes a tablet delivery system. Marketed by Dr. Reddy's Labratories Inc., this product is identified by NDC 75907-028 and is authorized under FDA application ANDA074921.

Identification & Billing

NDC Package Code
75907-028-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
75907-028
11-Digit Billing Format
75907002801
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
Estazolam
Non-Proprietary Name
Estazolam
Substance Name
Estazolam
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)
ESTAZOLAM 1 mg/1
Pharmacologic Class
Usage Information
Estazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see CLINICAL PHARMACOLOGY).Because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.There is evidence to support the ability of estazolam to enhance the duration and quality of sleep for intervals up to 12 weeks (see CLINICAL PHARMACOLOGY).
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Dr. Reddy's Labratories Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA074921
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-15-2024
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 75907-028-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Estazolam, a human prescription drug labeled by Dr. Reddy's Labratories Inc.. This tablet is formulated for oral use and contains estazolam 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 Dr. Reddy's Labratories Inc. on February 15, 2024. The current certification is valid through December 31, 2026.

How is this Dr. Reddy's Labratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75907002801. 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)
75907-028-01
11-Digit CMS (5-4-2)
75907-0028-01

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