Phenadoz
NDC Package 0591-2160-39

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.

Phenadoz is see also Warning section. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-2160 and is authorized under FDA application ANDA040479.

Identification & Billing

NDC Package Code
0591-2160-39
Package Description
12 PACKET in 1 BOX / 1 SUPPOSITORY in 1 PACKET
Product Code
11-Digit Billing Format
00591216039
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
12 EA

Clinical Specifications

Proprietary Name
Phenadoz
Dosage Form
-
Usage Information
See also Warning section. Promethazine is used to prevent and treat nausea and vomiting related to certain conditions (such as motion sickness, or before/after surgery). It is also used to treat allergy symptoms such as rash, itching, and runny nose. It may be used to help you feel sleepy/relaxed before and after surgery or to help certain opioid pain relievers (such as meperidine) work better. The suppository form is used when medications cannot be taken by mouth. Promethazine is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its other effects (such as anti-nausea, calming, pain relief) may work by affecting other natural substances (such as acetylcholine) and by acting directly on certain parts of the brain.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
FDA Application #
ANDA040479
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-12-2013
End Marketing Date
11-30-2016
Listing Expiration
11-30-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0591-2160-39 identifies a specific commercial package of 12 packet in 1 box / 1 suppository in 1 packet of Phenadoz, labeled by Actavis Pharma, Inc.. 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 Actavis Pharma, Inc. on February 12, 2013. The current certification is valid through November 30, 2016.

What are the primary indications for this medication?

See also Warning section. Promethazine is used to prevent and treat nausea and vomiting related to certain conditions (such as motion sickness, or before/after surgery). It is also used to treat allergy symptoms such as rash, itching, and runny nose. It may be used to help you feel sleepy/relaxed before and after surgery or to help certain opioid pain relievers (such as meperidine) work better. The suppository form is used when medications cannot be taken by mouth. Promethazine is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its other effects (such as anti-nausea, calming, pain relief) may work by affecting other natural substances (such as acetylcholine) and by acting directly on certain parts of the brain.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591216039. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 12 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 (4-4-2)
0591-2160-39
11-Digit CMS (5-4-2)
00591-2160-39

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