What is NDC 50419-424?

50419-424 is the product NDC for Kyleena (levonorgestrel), Levonorgestrel 19.5 mg/1 intrauterine device, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Kyleena?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Kyleena NDC 50419-424 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50419-424Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50419-0424Add 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
50419-424-01	50419042401	1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)Marketed from Sep 19, 2016
50419-424-08	50419042408	1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08)Marketed from Sep 19, 2016
50419-424-71	50419042471	1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-71)Marketed from Sep 19, 2016 · Sample package

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): Kyleena
Generic name (nonproprietary): levonorgestrel
Active ingredients: Levonorgestrel — 19.5 mg/1
Dosage form: Intrauterine device
Route: Intrauterine
Labeler: Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208224
Marketing start: Sep 19, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 50419-424_e22aea7f-9d28-426d-879a-4723fa76f2c2SPL ID e22aea7f-9d28-426d-879a-4723fa76f2c2SPL set ID 2e07c155-21e1-4781-9633-ce8bddd47080RxCUI 1811886, 1856546UNII 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

N450419042401 followed by a unit qualifier and the quantity

Package 50419-0424-01. 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 Oct 23, 2025.

Indications (excerpt from the label)

Kyleena is indicated to prevent pregnancy for up to 5 years. Replace the system after 5 years if continued use is desired. Kyleena is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 5 years. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50419-424

What is NDC 50419-424?: 50419-424 is the product NDC for Kyleena (levonorgestrel), Levonorgestrel 19.5 mg/1 intrauterine device, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Kyleena (Levonorgestrel).
What is the active ingredient?: Levonorgestrel.
Who is the labeler?: Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Kyleena?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Kyleena (Levonorgestrel) NDC 50419-424