Oxazepam Capsule, Gelatin Coated
NDC Package 62584-813-01

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

Package Information

Oxazepam capsules is oxazepam is used to treat anxiety and also acute alcohol withdrawal. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by American Health Packaging, this product is identified by NDC 62584-813 and is authorized under FDA application ANDA072253.

Identification & Billing

NDC Package Code
62584-813-01
Package Description
100 BLISTER PACK in 1 CARTON / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (62584-813-11)
Product Code
62584-813
11-Digit Billing Format
62584081301
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
Oxazepam
Non-Proprietary Name
Oxazepam
Substance Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXAZEPAM 15 mg/1
Pharmacologic Class
Usage Information
Oxazepam is used to treat anxiety and also acute alcohol withdrawal. This medication belongs to a class of drugs called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming and an anti-seizure effect. It works by enhancing the effects of a certain natural substance in the body (GABA). This medication may also be used for sleep (insomnia)
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
American Health Packaging
Product Type
Human Prescription Drug
FDA Application #
ANDA072253
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-17-2007
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 62584-813-01 identifies a specific commercial package of 100 blister pack in 1 carton / 1 capsule, gelatin coated in 1 blister pack (62584-813-11) of Oxazepam, a human prescription drug labeled by American Health Packaging. This capsule, gelatin coated is formulated for oral use and contains oxazepam 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 American Health Packaging on December 17, 2007. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Oxazepam is used to treat anxiety and also acute alcohol withdrawal. This medication belongs to a class of drugs called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming and an anti-seizure effect. It works by enhancing the effects of a certain natural substance in the body (GABA). This medication may also be used for sleep (insomnia)

How is this American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62584081301. 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)
62584-813-01
11-Digit CMS (5-4-2)
62584-0813-01

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