Phenergan
NDC Package 60977-002-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Baxter Healthcare Corporation, this product is identified by NDC 60977-002 and is authorized under FDA application ANDA083312.

Identification & Billing

NDC Package Code
60977-002-04
Package Description
25 VIAL, SINGLE-DOSE in 1 PACKAGE / 1 mL in 1 VIAL, SINGLE-DOSE (60977-002-44)
Product Code
60977-002
11-Digit Billing Format
60977000204

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
Baxter Healthcare Corporation
FDA Application #
ANDA083312
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-10-2009
End Marketing Date
04-30-2014
Listing Expiration
04-30-2014
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 (60977-002). Click a package code to view its specific billing and regulatory data.

60977-002-02
25 AMPULE in 1 PACKAGE / 1 mL in 1 AMPULE (60977-002-43)

* 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 60977-002-04 identifies a specific commercial package of 25 vial, single-dose in 1 package / 1 ml in 1 vial, single-dose (60977-002-44) of Phenergan, labeled by Baxter Healthcare Corporation. 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 Baxter Healthcare Corporation on December 10, 2009. The current certification is valid through April 30, 2014.

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 Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60977000204. 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)
60977-002-04
11-Digit CMS (5-4-2)
60977-0002-04

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