Skyla (levonorgestrel) NDC 50419-422

NDC codes

FDA NDC Directory

Product NDC (as listed)50419-422Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50419-0422Add 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
50419-422-01	50419042201	1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01)Marketed from Jan 11, 2013
50419-422-08	50419042208	1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-08)Marketed from Jan 11, 2013

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): Skyla
Generic name (nonproprietary): levonorgestrel
Active ingredients: Levonorgestrel — 13.5 mg/1
Dosage form: Intrauterine device
Route: Intrauterine
Labeler: Bayer HealthCare Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203159
Marketing start: Jan 11, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 50419-422_01b52e09-d273-4503-8589-a2bb64c1574cSPL ID 01b52e09-d273-4503-8589-a2bb64c1574cSPL set ID 9f44ff35-e052-49cd-a1c2-0bfd87d49309RxCUI 1366334, 1366339UNII 5W7SIA7YZW
Pharmacologic class: 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N450419042201 followed by a unit qualifier and the quantity

Package 50419-0422-01. 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 Mar 4, 2026.

Indications (excerpt from the label)

Skyla ® is indicated to prevent pregnancy for up to 3 years. Replace the system after 3 years if continued use is desired. Skyla is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 3 years. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)