NDC 50474-500

Nayzilam

Midazolam

Nayzilam is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by Ucb, Inc.. The primary component is Midazolam.

Product ID50474-500_75111466-7ca2-48f8-b55b-9c4e7da49e55
NDC50474-500
Product TypeHuman Prescription Drug
Proprietary NameNayzilam
Generic NameMidazolam
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2019-05-17
Marketing CategoryNDA / NDA
Application NumberNDA211321
Labeler NameUCB, Inc.
Substance NameMIDAZOLAM
Active Ingredient Strength5 mg/.1mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 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
Marketing Start Date2019-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50474-500-14 [50474050014]

Nayzilam SPRAY
Marketing CategoryNDA
Application NumberNDA211321
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-17

NDC 50474-500-15 [50474050015]

Nayzilam SPRAY
Marketing CategoryNDA
Application NumberNDA211321
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-17

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM5 mg/.1mL

OpenFDA Data

SPL SET ID:2b29422e-54d5-4a49-8522-e9cf752368c3
Manufacturer
UNII

Pharmacological Class

  • Benzodiazepine [EPC]
  • Benzodiazepines [CS]
  • Benzodiazepine [EPC]
  • Benzodiazepines [CS]

NDC Crossover Matching brand name "Nayzilam" or generic name "Midazolam"

NDCBrand NameGeneric Name
50474-500Nayzilammidazolam
0404-9912MidazolamMidazolam
0404-9913MidazolamMidazolam
0404-9915MidazolamMidazolam
0641-6056MidazolamMidazolam
0641-6057MidazolamMidazolam
0641-6059MidazolamMidazolam
0641-6060MidazolamMidazolam
0641-6061MidazolamMidazolam
0641-6063MidazolamMidazolam
0641-6190MidazolamMidazolam
0641-6209MidazolamMidazolam
0641-6210MidazolamMidazolam
0641-6211MidazolamMidazolam
50090-0683MidazolamMidazolam
50090-0738MidazolamMidazolam
51662-1236MIDAZOLAMMIDAZOLAM
51662-1237MIDAZOLAMMIDAZOLAM
51662-1324MIDAZOLAMMIDAZOLAM
52584-055MidazolamMidazolam
52584-056MidazolamMidazolam
52584-059MidazolamMidazolam
52584-081MidazolamMidazolam

Trademark Results [Nayzilam]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NAYZILAM
NAYZILAM
88312000 not registered Live/Pending
UCB Biopharma SPRL
2019-02-22
NAYZILAM
NAYZILAM
86419161 5386953 Live/Registered
UCB BIOPHARMA SPRL
2014-10-09

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