Temazepam
NDC Package 49999-045-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Temazepam is a medication used to treat a certain sleep problem (insomnia). Marketed by Lake Erie Medical Dba Quality Care Products Llc, this product is identified by NDC 49999-045 and is authorized under FDA application ANDA070920.

Identification & Billing

NDC Package Code
49999-045-60
Package Description
60 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
49999004560
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

Clinical Specifications

Proprietary Name
Temazepam
Dosage Form
-
Usage Information
This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Temazepam belongs to a class of drugs called benzodiazepines. It acts on your brain to produce a calming effect. Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.

Regulatory & Marketing

Labeler Name
Lake Erie Medical Dba Quality Care Products Llc
FDA Application #
ANDA070920
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-03-2011
End Marketing Date
06-01-2014
Listing Expiration
06-01-2014
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49999-045). Click a package code to view its specific billing and regulatory data.

15 CAPSULE in 1 BOTTLE, PLASTIC
30 CAPSULE in 1 BOTTLE, PLASTIC
90 CAPSULE in 1 BOTTLE, PLASTIC

* 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 49999-045-60 identifies a specific commercial package of 60 capsule in 1 bottle, plastic of Temazepam, labeled by Lake Erie Medical Dba Quality Care Products Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. 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 Lake Erie Medical Dba Quality Care Products Llc on August 03, 2011. The current certification is valid through June 01, 2014.

What are the primary indications for this medication?

This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Temazepam belongs to a class of drugs called benzodiazepines. It acts on your brain to produce a calming effect. Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.

How is this Lake Erie Medical Dba Quality Care Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49999004560. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
49999-045-60
11-Digit CMS (5-4-2)
49999-0045-60

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