Option 2 Tablet
NDC Package 0113-2003-12

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Option 2 (levonorgestrel) tablets is levonorgestrel is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. This formulation utilizes a tablet delivery system. Marketed by L. Perrigo Company, this product is identified by NDC 0113-2003 and is authorized under FDA application ANDA202334.

Identification & Billing

NDC Package Code
0113-2003-12
Package Description
1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code
11-Digit Billing Format
00113200312
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Option 2
Non-Proprietary Name
Levonorgestrel
Substance Name
Levonorgestrel
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)
Usage Information
Levonorgestrel is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. This medication is an emergency contraceptive and should not be used as a regular form of birth control. It is a progestin hormone that works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. Using this medication will not stop an existing pregnancy or protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia). This medication may not work well in women over a certain weight (for example, greater than 164 pounds or 74 kilograms), or if you have used certain other medications within the past month. This effect can result in pregnancy. Talk to your doctor for more details and to see if this medication is right for you (see also Drug Interactions section). Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
L. Perrigo Company
Product Type
Human Otc Drug
FDA Application #
ANDA202334
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-29-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0113-2003-12 identifies a specific commercial package of 1 blister pack in 1 carton / 1 tablet in 1 blister pack of Option 2, a human over the counter drug labeled by L. Perrigo Company. This tablet is formulated for oral use and contains levonorgestrel 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 January 29, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Levonorgestrel is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. This medication is an emergency contraceptive and should not be used as a regular form of birth control. It is a progestin hormone that works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. Using this medication will not stop an existing pregnancy or protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia). This medication may not work well in women over a certain weight (for example, greater than 164 pounds or 74 kilograms), or if you have used certain other medications within the past month. This effect can result in pregnancy. Talk to your doctor for more details and to see if this medication is right for you (see also Drug Interactions section). Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00113200312. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
0113-2003-12
11-Digit CMS (5-4-2)
00113-2003-12

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