NDC Package 0615-8217-39 Loratadine Antihistamine

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

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:
0615-8217-39
Package Description:
30 TABLET in 1 BLISTER PACK
Product Code:
Proprietary Name:
Loratadine Antihistamine
Non-Proprietary Name:
Loratadine
Substance Name:
Loratadine
Usage Information:
This medication is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergies. It is also used to relieve itching from hives. Loratadine does not prevent hives or prevent/treat a serious allergic reaction (anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use loratadine in place of your epinephrine. If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions section.) If you are using the tablets or capsules, do not use in children younger than 6 years unless directed by the doctor. If you are using the liquid or chewable tablets, do not use in children younger than 2 years unless directed by the doctor.
11-Digit NDC Billing Format:
00615821739
NDC to RxNorm Crosswalk:
  • RxCUI: 311372 - loratadine 10 MG 24HR Oral Tablet
  • RxCUI: 311372 - loratadine 10 MG Oral Tablet
  • RxCUI: 311372 - loratadine 10 MG 24 HR Oral Tablet
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Ncs Healthcare Of Ky, Llc Dba Vangard Labs
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA076301
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-11-2018
    End Marketing Date:
    11-30-2024
    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 0615-8217-39?

    The NDC Packaged Code 0615-8217-39 is assigned to a package of 30 tablet in 1 blister pack of Loratadine Antihistamine, a human over the counter drug labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0615-8217 included in the NDC Directory?

    Yes, Loratadine Antihistamine with product code 0615-8217 is active and included in the NDC Directory. The product was first marketed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs on July 11, 2018.

    What is the 11-digit format for NDC 0615-8217-39?

    The 11-digit format is 00615821739. 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 4-4-2 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
    4-4-20615-8217-395-4-200615-8217-39