Twirla (levonorgestrel/ethinyl estradiol) NDC 71671-100

NDC codes

FDA NDC Directory

Product NDC (as listed)71671-100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71671-0100Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71671-100-01	71671010001	1 POUCH in 1 CARTON (71671-100-01) / 1 PATCH in 1 POUCH (71671-100-11)Marketed from Sep 11, 2020
71671-100-03	71671010003	3 POUCH in 1 CARTON (71671-100-03) / 1 PATCH in 1 POUCH (71671-100-11)Marketed from Sep 11, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Twirla
Generic name (nonproprietary): levonorgestrel/ethinyl estradiol
Active ingredients: Levonorgestrel — 2.6 mg/1Ethinyl estradiol — 2.3 mg/1
Dosage form: Patch
Route: Transdermal
Labeler: Agile Therapeutics, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 204017
Marketing start: Sep 11, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 71671-100_557e8f45-e388-68b8-e063-6294a90a2586SPL ID 557e8f45-e388-68b8-e063-6294a90a2586SPL set ID bcaf8db0-1750-425d-b008-255b5e7a9cc6RxCUI 2396242, 2396253, 2396258, 2396259UNII 5W7SIA7YZW, 423D2T571UUPC 0371671100116
Pharmacologic class: Estrogen; Progestin; Progestin-containing Intrauterine System

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471671010001 followed by a unit qualifier and the quantity

Package 71671-0100-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 30, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitation of Use Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m 2 before prescribing TWIRLA [see Use in Specific Populations ( 8.9 ) and Clinical Studies ( 14 )] . TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m 2 [see Contraindications ( 4 )] . TWIRLA is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)