Opill Tablet
NDC Package 0113-8101-04

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

Package Information

Opill (norgestrel) tablets is •take 1 tablet at the same time every day•this product will work best to prevent pregnancy when taken exactly as directed•you can start on any day of the month•use a condom (or another barrier method) every time you have sex during the first 2 days of use (48 hours) after you start your first pack of this product, because it takes 2 days for this product to start workingSee the enclosed leaflet for more information on how to switch from another contraceptive method.•never skip your daily tablet•to prevent pregnancy, take this product every day, even when you bleed or have spotting•when you finish this pack, start the next one the following day without a break•if you are more than 3 hours late taking your tablet or miss taking your tablet on 1 more days:•take 1 tablet immediately, as soon as you remember that you missed it•then go back to taking your daily tablet at your usual time•use a condom (or another barrier method) every time you have sex during the next 2 days (48 hours), because it takes 2 days for this product to start working again•if you vomit for any reason or have severe diarrhea within 4 hours of taking your daily tablet, use a condom (or another barrier method) every time you have sex for the next 2 days (48 hours), because the medicine may not have been fully absorbed•you should continue to see your healthcare provider(s) for routine healthcare visitsWhen to use a condom (or another barrier method)•every time you have sex for the next 2 days (48 hours):•after you start your first pack of this product•if you take a tablet more than 3 hours late or miss a tablet on 1 or more days•if you vomit or have a severe diarrhea within 4 hours of taking a tablet. This formulation utilizes a tablet delivery system. Marketed by L. Perrigo Company, this product is identified by NDC 0113-8101 and is authorized under FDA application NDA017031.

Identification & Billing

NDC Package Code
0113-8101-04
Package Description
4 BLISTER PACK in 1 PACKAGE / 28 TABLET in 1 BLISTER PACK
Product Code
0113-8101
11-Digit Billing Format
00113810104
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Opill
Non-Proprietary Name
Norgestrel
Substance Name
Norgestrel
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NORGESTREL .075 mg/1
Usage Information
•take 1 tablet at the same time every day•this product will work best to prevent pregnancy when taken exactly as directed•you can start on any day of the month•use a condom (or another barrier method) every time you have sex during the first 2 days of use (48 hours) after you start your first pack of this product, because it takes 2 days for this product to start workingSee the enclosed leaflet for more information on how to switch from another contraceptive method.•never skip your daily tablet•to prevent pregnancy, take this product every day, even when you bleed or have spotting•when you finish this pack, start the next one the following day without a break•if you are more than 3 hours late taking your tablet or miss taking your tablet on 1 more days:•take 1 tablet immediately, as soon as you remember that you missed it•then go back to taking your daily tablet at your usual time•use a condom (or another barrier method) every time you have sex during the next 2 days (48 hours), because it takes 2 days for this product to start working again•if you vomit for any reason or have severe diarrhea within 4 hours of taking your daily tablet, use a condom (or another barrier method) every time you have sex for the next 2 days (48 hours), because the medicine may not have been fully absorbed•you should continue to see your healthcare provider(s) for routine healthcare visitsWhen to use a condom (or another barrier method)•every time you have sex for the next 2 days (48 hours):•after you start your first pack of this product•if you take a tablet more than 3 hours late or miss a tablet on 1 or more days•if you vomit or have a severe diarrhea within 4 hours of taking a tablet

Regulatory & Marketing

Labeler Name
L. Perrigo Company
Product Type
Human Otc Drug
FDA Application #
NDA017031
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-04-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0113-8101). Click a package code to view its specific billing and regulatory data.

0113-8101-01
1 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK
0113-8101-03
3 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK
0113-8101-06
6 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK

* 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 0113-8101-04 identifies a specific commercial package of 4 blister pack in 1 package / 28 tablet in 1 blister pack of Opill, a human over the counter drug labeled by L. Perrigo Company. This tablet is formulated for oral use and contains norgestrel 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 L. Perrigo Company on March 04, 2024. The current certification is valid through December 31, 2026.

How is this L. Perrigo Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00113810104. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 total billable units per package. 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)
0113-8101-04
11-Digit CMS (5-4-2)
00113-8101-04

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