nayzilam

Generic: midazolam

Labeler: ucb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nayzilam
Generic Name midazolam
Labeler ucb, inc.
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

midazolam 5 mg/.1mL

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-500
Product ID 50474-500_5776d86f-c632-429f-ac0b-88ade1a3930c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211321
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-05-17

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50474500
Hyphenated Format 50474-500

Supplemental Identifiers

RxCUI
2173494 2173500
UNII
R60L0SM5BC
NUI
N0000175694 M0002356

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nayzilam (source: ndc)
Generic Name midazolam (source: ndc)
Application Number NDA211321 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/.1mL
source: ndc
Packaging
  • 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-DOSE
source: ndc

Packages (1)

50474-500-15 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-DOSE

Ingredients (1)

midazolam (5 mg/.1mL)

Linked Drug Pages (1)

Nayzilam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "5776d86f-c632-429f-ac0b-88ade1a3930c", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["R60L0SM5BC"], "rxcui": ["2173494", "2173500"], "spl_set_id": ["2b29422e-54d5-4a49-8522-e9cf752368c3"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["UCB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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-DOSE", "package_ndc": "50474-500-15", "marketing_start_date": "20190517"}], "brand_name": "Nayzilam", "product_id": "50474-500_5776d86f-c632-429f-ac0b-88ade1a3930c", "dosage_form": "SPRAY", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "50474-500", "dea_schedule": "CIV", "generic_name": "midazolam", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nayzilam", "active_ingredients": [{"name": "MIDAZOLAM", "strength": "5 mg/.1mL"}], "application_number": "NDA211321", "marketing_category": "NDA", "marketing_start_date": "20190517", "listing_expiration_date": "20261231"}