Twirla Patch
NDC Package 71671-100-01

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

Twirla (levonorgestrel/ethinyl estradiol) patches is tWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.Limitation of UseConsider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m2 before prescribing TWIRLA [see Use in Specific Populations (8.9) and Clinical Studies (14)]. This formulation utilizes a patch delivery system. Marketed by Agile Therapeutics, Inc., this product is identified by NDC 71671-100 and is authorized under FDA application NDA204017.

Identification & Billing

NDC Package Code
71671-100-01
Package Description
1 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (71671-100-11)
Product Code
71671-100
11-Digit Billing Format
71671010001
RxNorm Crosswalk
  • RxCUI: 2396242 - ethinyl estradiol 120 MCG / levonorgestrel 30 MCG per 24 HR Weekly Transdermal System
  • RxCUI: 2396242 - 168 HR ethinyl estradiol 0.00125 MG/HR / levonorgestrel 0.005 MG/HR Transdermal System
  • RxCUI: 2396253 - {3 (168 HR ethinyl estradiol 0.00125 MG/HR / levonorgestrel 0.005 MG/HR Transdermal System) } Pack
  • RxCUI: 2396253 - ethinyl estradiol 120 MCG / levonorgestrel 30 MCG per 24 HR Weekly Transdermal System, 3 Count
  • RxCUI: 2396258 - Twirla Weekly Replacement Transdermal System

Clinical Specifications

Proprietary Name
Twirla
Non-Proprietary Name
Levonorgestrel/ethinyl Estradiol
Substance Name
Ethinyl Estradiol; Levonorgestrel
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
Pharmacologic Class
Usage Information
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.Limitation of UseConsider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m2 before prescribing TWIRLA [see Use in Specific Populations (8.9) and Clinical Studies (14)]. TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m2 [see Contraindications (4)].

Regulatory & Marketing

Labeler Name
Agile Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA204017
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-11-2020
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 (71671-100). Click a package code to view its specific billing and regulatory data.

71671-100-03
3 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (71671-100-11)

* 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 71671-100-01 identifies a specific commercial package of 1 pouch in 1 carton / 1 patch in 1 pouch (71671-100-11) of Twirla, a human prescription drug labeled by Agile Therapeutics, Inc.. This patch is formulated for transdermal use and contains ethinyl estradiol; 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 Agile Therapeutics, Inc. on September 11, 2020. The current certification is valid through December 31, 2026.

How is this Agile Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71671010001. 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 (5-3-2)
71671-100-01
11-Digit CMS (5-4-2)
71671-0100-01

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