1. Home
  2. Labeler Index
  3. General Injectables & Vaccines, Inc
  4. 52584-496
  5. NDC Package Code: 52584-496-31 Promethazine Hydrochloride

NDC Package 52584-496-31 Promethazine Hydrochloride

Injection, Solution Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
52584-496-31
Package Description:
1 AMPULE in 1 BAG / 1 mL in 1 AMPULE
Product Code:
52584-496
Proprietary Name:
Promethazine Hydrochloride
Non-Proprietary Name:
Promethazine Hydrochloride
Substance Name:
Promethazine Hydrochloride
Usage Information:
Promethazine hydrochloride injection is indicated for the following conditions:Amelioration of allergic reactions to blood or plasma.In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.Active treatment of motion sickness.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.As an adjunct to analgesics for the control of postoperative pain.Preoperative, postoperative, and obstetric (during labor) sedation.Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.
11-Digit NDC Billing Format:
52584049631
NDC to RxNorm Crosswalk:
  • RxCUI: 992858 - promethazine HCl 50 MG in 1 ML Injection
  • RxCUI: 992858 - 1 ML promethazine hydrochloride 50 MG/ML Injection
  • RxCUI: 992858 - promethazine HCl 50 MG per 1 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    General Injectables & Vaccines, Inc
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • PROMETHAZINE HYDROCHLORIDE 50 mg/mL
    • Pharmacologic Class(es):
  • Phenothiazine - [EPC] (Established Pharmacologic Class)
  • Phenothiazines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA083312
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-01-2010
    End Marketing Date:
    05-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 52584-496-31?

    The NDC Packaged Code 52584-496-31 is assigned to a package of 1 ampule in 1 bag / 1 ml in 1 ampule of Promethazine Hydrochloride, a human prescription drug labeled by General Injectables & Vaccines, Inc. The product's dosage form is injection, solution and is administered via intramuscular form.

    Is NDC 52584-496 included in the NDC Directory?

    Yes, Promethazine Hydrochloride with product code 52584-496 is active and included in the NDC Directory. The product was first marketed by General Injectables & Vaccines, Inc on August 01, 2010.

    What is the 11-digit format for NDC 52584-496-31?

    The 11-digit format is 52584049631. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-252584-496-315-4-252584-0496-31