Phenergan Injection
NDC Package 0641-6083-25

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

Package Information

Phenergan (promethazine hydrochloride) injection 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 injection delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0641-6083 and is authorized under FDA application ANDA083312.

Identification & Billing

NDC Package Code
0641-6083-25
Package Description
25 AMPULE in 1 CARTON / 1 mL in 1 AMPULE (0641-6083-01)
Product Code
0641-6083
11-Digit Billing Format
00641608325
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Phenergan
Non-Proprietary Name
Promethazine Hydrochloride
Substance Name
Promethazine Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
PROMETHAZINE HYDROCHLORIDE 50 mg/mL
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
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA083312
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-19-1973
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 0641-6083-25 identifies a specific commercial package of 25 ampule in 1 carton / 1 ml in 1 ampule (0641-6083-01) of Phenergan, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This injection is formulated for intramuscular 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 Hikma Pharmaceuticals Usa Inc. on September 19, 1973. The current certification is valid through December 31, 2026.

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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00641608325. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0641-6083-25
11-Digit CMS (5-4-2)
00641-6083-25

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