Zolpidem Tartrate Sublingual Tablet
NDC Package 49884-899-11

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

Package Information

Zolpidem Tartrate Sublingual tablets is zolpidem is used to treat a certain sleep problem (insomnia) in adults. This formulation utilizes a tablet delivery system. Marketed by Par Health Usa, Llc, this product is identified by NDC 49884-899 and is authorized under FDA application ANDA204229.

Identification & Billing

NDC Package Code
49884-899-11
Package Description
30 POUCH in 1 CARTON / 1 TABLET in 1 POUCH (49884-899-52)
Product Code
49884-899
11-Digit Billing Format
49884089911
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zolpidem Tartrate Sublingual
Non-Proprietary Name
Zolpidem Tartrate Sublingual
Substance Name
Zolpidem Tartrate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
ZOLPIDEM TARTRATE 3.5 mg/1
Pharmacologic Class
Usage Information
Zolpidem is used to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. This medication is usually limited to short treatment periods of 1 to 2 weeks or less.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Par Health Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204229
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-11-2017
Listing Expiration
12-31-2027
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 49884-899-11 identifies a specific commercial package of 30 pouch in 1 carton / 1 tablet in 1 pouch (49884-899-52) of Zolpidem Tartrate Sublingual, a human prescription drug labeled by Par Health Usa, Llc. This tablet is formulated for sublingual use and contains zolpidem tartrate 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 Par Health Usa, Llc on September 11, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Zolpidem is used to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. This medication is usually limited to short treatment periods of 1 to 2 weeks or less.

How is this Par Health Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49884089911. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
49884-899-11
11-Digit CMS (5-4-2)
49884-0899-11

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