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  5. NDC Package Code: 14335-440-01 Phenylephrine Hydrochloride

NDC Package 14335-440-01 Phenylephrine Hydrochloride

Injection Intravenous - 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:
14335-440-01
Package Description:
25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code:
14335-440
Proprietary Name:
Phenylephrine Hydrochloride
Non-Proprietary Name:
Phenylephrine Hydrochloride
Substance Name:
Phenylephrine Hydrochloride
Usage Information:
Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
11-Digit NDC Billing Format:
14335044001
NDC to RxNorm Crosswalk:
  • RxCUI: 1232651 - phenylephrine HCl 10 MG/ML Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 10 MG/ML Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 1 % Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 100 MG per 10 ML Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 50 MG per 5 ML Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hainan Poly Pharm. Co., Ltd.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA218412
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-19-2024
    Listing Expiration Date:
    12-31-2025
    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 14335-440-01?

    The NDC Packaged Code 14335-440-01 is assigned to a package of 25 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose of Phenylephrine Hydrochloride, a human prescription drug labeled by Hainan Poly Pharm. Co., Ltd.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 14335-440 included in the NDC Directory?

    Yes, Phenylephrine Hydrochloride with product code 14335-440 is active and included in the NDC Directory. The product was first marketed by Hainan Poly Pharm. Co., Ltd. on March 19, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 14335-440-01?

    The 11-digit format is 14335044001. 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
    5-3-214335-440-015-4-214335-0440-01