Phenergan
NDC Package 40076-320-12

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

Package Information

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

Phenergan is promethazine is used to prevent and treat nausea and vomiting related to certain conditions (such as before/after surgery, motion sickness). Marketed by Prestium Pharma, Inc., this product is identified by NDC 40076-320 and is authorized under FDA application ANDA087165.

Identification & Billing

NDC Package Code
40076-320-12
Package Description
12 SUPPOSITORY in 1 BOX
Product Code
40076-320
11-Digit Billing Format
40076032012
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
Phenergan
Dosage Form
-
Usage Information
Promethazine is used to prevent and treat nausea and vomiting related to certain conditions (such as before/after surgery, motion sickness). It is also used with other medication to treat severe allergic reactions (anaphylaxis) and reactions to blood products. It may also be used to treat milder allergic reactions when you cannot take promethazine by mouth. It may also be used to help you feel sleepy/relaxed before and after surgery, during other procedures, or during labor and delivery. It may also be used to help certain opioid pain relievers (such as meperidine) work better. 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. This drug is not approved for use in children younger than 2 years due to an increased risk of side effects (such as slow/shallow breathing). See also Warning section.

Regulatory & Marketing

Labeler Name
Prestium Pharma, Inc.
FDA Application #
ANDA087165
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2014
End Marketing Date
01-01-2018
Listing Expiration
01-01-2018
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 40076-320-12 identifies a specific commercial package of 12 suppository in 1 box of Phenergan, labeled by Prestium Pharma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 12 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 Prestium Pharma, Inc. on August 01, 2014. The current certification is valid through January 01, 2018.

What are the primary indications for this medication?

Promethazine is used to prevent and treat nausea and vomiting related to certain conditions (such as before/after surgery, motion sickness). It is also used with other medication to treat severe allergic reactions (anaphylaxis) and reactions to blood products. It may also be used to treat milder allergic reactions when you cannot take promethazine by mouth. It may also be used to help you feel sleepy/relaxed before and after surgery, during other procedures, or during labor and delivery. It may also be used to help certain opioid pain relievers (such as meperidine) work better. 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. This drug is not approved for use in children younger than 2 years due to an increased risk of side effects (such as slow/shallow breathing). See also Warning section.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40076032012. 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 (5-3-2)
40076-320-12
11-Digit CMS (5-4-2)
40076-0320-12

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