FDA.reportPublic FDA data

Nayzilam

Product NDC
50474-500
11-digit product format
504740500
Labeler code
50474
Product ID
50474-500_5776d86f-c632-429f-ac0b-88ade1a3930c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midazolam
Dosage form
SPRAY
Route
NASAL
Labeler
UCB, Inc.
Application
NDA211321
Marketing category
NDA
Marketing start
2019-05-17
Substance
MIDAZOLAM
Active strength
5 mg/.1mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nayzilam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM5 mg/.1mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR60L0SM5BC
Rxcui2173494, 2173500

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d526338-43ba-4cef-8730-5a757122f8ceProduct name120260218
8118475d-d61b-4326-b353-56e9cf8c8d9fProduct name320260218
f69f3735-bf62-03e6-cc7a-5af4af89ec8aProduct name520250516
4cc03496-da49-494d-b71d-757fe6737fa2Product name120230717
06641162-4d53-492d-8ff2-5951a469060fProduct name120230420
46ca420c-e4d5-4e6c-9b2f-cea269a262e8Product name120230320
b84efe2b-3f4e-4b09-90f9-1d24a61ec30eProduct name120190808
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16Product name120181220
31f18c4e-1938-700a-43de-b9e218c36edcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50474-500-14Nayzilam0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.14
50474-500-14Nayzilam1 in 1 BLISTER PACKSPRAY14
50474-500-15Nayzilam2 in 1 CARTONSPRAY24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50474-500-14EA - Each50474-5000ef91d6c-2f28-4bdd-b137-1fdba33a1c7612019-10-07
50474-500-15EA - Each50474-500a28b3eec-32c7-4ab1-aebc-d68eafb7646112019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50474-500NAYZILAM (MIDAZOLAM) SPRAY [UCB, INC.]4Current NDC, Legacy NDC, 3 package rows20230131_2b29422e-54d5-4a49-8522-e9cf752368c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2173494midazolam 5 MG in 0.1 mL Nasal SprayPSN2b29422e-54d5-4a49-8522-e9cf752368c34
2173500Nayzilam 5 MG in 0.1 mL Nasal SprayPSN2b29422e-54d5-4a49-8522-e9cf752368c34
2173500midazolam 50 MG/ML Nasal Spray [Nayzilam]SBD2b29422e-54d5-4a49-8522-e9cf752368c34
2173494midazolam 50 MG/ML Nasal SpraySCD2b29422e-54d5-4a49-8522-e9cf752368c34
2173494midazolam 5 MG per 0.1 ML Nasal SpraySY2b29422e-54d5-4a49-8522-e9cf752368c34
2173500Nayzilam 5 MG per 0.1 ML Nasal SpraySY2b29422e-54d5-4a49-8522-e9cf752368c34
2173500Nayzilam 50 MG/ML Nasal SpraySY2b29422e-54d5-4a49-8522-e9cf752368c34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50474-500-14504740500140.1 mL in 1 VIAL, SINGLE-DOSE0.1 mlHistorical
50474-500-15504740500152 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-DOSE2 blister pack2019-05-170000-00-00NoNoCurrent