What is NDC 50474-500?

50474-500 is the product NDC for Nayzilam (midazolam), Midazolam 5 mg/.1mL spray, listed with the FDA by UCB, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

UCB, Inc., NDC labeler code 50474. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nayzilam?

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.

Nayzilam NDC 50474-500 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50474-500Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50474-0500Add 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
50474-500-15	50474050015	2 BLISTER PACK in 1 CARTON (50474-500-15) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (50474-500-14) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from May 17, 2019

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): Nayzilam
Generic name (nonproprietary): midazolam
Active ingredients: Midazolam — 5 mg/.1mL
Dosage form: Spray
Route: Nasal
Labeler: UCB, Inc.NDC labeler code 50474
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211321
Marketing start: May 17, 2019
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 50474-500_5776d86f-c632-429f-ac0b-88ade1a3930cSPL ID 5776d86f-c632-429f-ac0b-88ade1a3930cSPL set ID 2b29422e-54d5-4a49-8522-e9cf752368c3RxCUI 2173494, 2173500UNII R60L0SM5BC
Pharmacologic class: Benzodiazepine

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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450474050015 followed by a unit qualifier and the quantity

Package 50474-0500-15. 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 Jan 19, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

NAYZILAM is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. NAYZILAM is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50474-500

What is NDC 50474-500?: 50474-500 is the product NDC for Nayzilam (midazolam), Midazolam 5 mg/.1mL spray, listed with the FDA by UCB, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nayzilam (Midazolam).
What is the active ingredient?: Midazolam.
Who is the labeler?: UCB, Inc., NDC labeler code 50474. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nayzilam?: 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.

Nayzilam (Midazolam) NDC 50474-500