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  5. NDC Package Code: 35916-1654-1 Pamabrom

NDC Package 35916-1654-1 Pamabrom

Capsule, Liquid Filled Oral - 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:
35916-1654-1
Package Description:
48 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code:
35916-1654
Proprietary Name:
Pamabrom
Non-Proprietary Name:
Pamabrom
Substance Name:
Pamabrom
Usage Information:
Read all package directions and warnings before use.Use only as directed.Adults: One (1) softgel capsule after breakfast with a full glass of water, Dose may be repeated after 6 hours, not to exceed four (4) softgel capsules per day.Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period.Drink 6 to 8 glasses of water daily.For use by normally healthy adults only.Persons under 18 years of age should use only as directed by a doctor.
11-Digit NDC Billing Format:
35916165401
NDC to RxNorm Crosswalk:
RxCUI: 832080 - pamabrom 50 MG Oral Capsule
Product Type:
Human Otc Drug
Labeler Name:
Softgel Healthcare Pvt Ltd
Dosage Form:
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
PAMABROM 50 mg/1
Sample Package:
No
FDA Application Number:
M027
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
05-21-2024
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 35916-1654-1?

The NDC Packaged Code 35916-1654-1 is assigned to a package of 48 capsule, liquid filled in 1 bottle of Pamabrom, a human over the counter drug labeled by Softgel Healthcare Pvt Ltd. The product's dosage form is capsule, liquid filled and is administered via oral form.

Is NDC 35916-1654 included in the NDC Directory?

Yes, Pamabrom with product code 35916-1654 is active and included in the NDC Directory. The product was first marketed by Softgel Healthcare Pvt Ltd on May 21, 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 35916-1654-1?

The 11-digit format is 35916165401. 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 5-4-1 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
5-4-135916-1654-15-4-235916-1654-01