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Nayzilam

These highlights do not include all the information needed to use NAYZILAM safely and effectively. See full prescribing information for NAYZILAM. NAYZILAM (midazolam) nasal spray, CIV Initial U.S. Approval: 1985

Approved
Approval ID

2b29422e-54d5-4a49-8522-e9cf752368c3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 19, 2023

Manufacturers
FDA

UCB, Inc.

DUNS: 028526403

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

midazolam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50474-500
Application NumberNDA211321
Product Classification
M
Marketing Category
C73594
G
Generic Name
midazolam
Product Specifications
Route of AdministrationNASAL
Effective DateJanuary 19, 2023
FDA Product Classification

INGREDIENTS (6)

midazolamActive
Quantity: 5 mg in 0.1 mL
Code: R60L0SM5BC
Classification: ACTIB
PEG-6 methyl etherInactive
Code: WXH089JZ5E
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT

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Nayzilam - FDA Drug Approval Details