Phenergan Tablet
NDC Package 72189-402-10

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

Phenergan (promethazine hcl) tablets is promethazine is used to prevent and treat nausea and vomiting related to certain conditions (such as before/after surgery, motion sickness). This formulation utilizes a tablet delivery system. Marketed by Direct_rx, this product is identified by NDC 72189-402 and is authorized under FDA application ANDA040596.

Identification & Billing

NDC Package Code
72189-402-10
Package Description
10 TABLET in 1 BOTTLE
Product Code
72189-402
11-Digit Billing Format
72189040210

Clinical Specifications

Proprietary Name
Phenergan
Non-Proprietary Name
Promethazine Hcl
Substance Name
Promethazine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PROMETHAZINE HYDROCHLORIDE 12.5 mg/1
Pharmacologic Class
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
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA040596
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2022
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72189-402). Click a package code to view its specific billing and regulatory data.

72189-402-12
12 TABLET in 1 BOTTLE
72189-402-30
30 TABLET in 1 BOTTLE

* 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 72189-402-10 identifies a specific commercial package of 10 tablet in 1 bottle of Phenergan, a human prescription drug labeled by Direct_rx. This tablet is formulated for oral use and contains promethazine hydrochloride 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 Direct_rx on December 01, 2022. The current certification is valid through December 31, 2027.

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 Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189040210. 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)
72189-402-10
11-Digit CMS (5-4-2)
72189-0402-10

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