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 ID: 50474-500_75111466-7ca2-48f8-b55b-9c4e7da49e55
• NDC: 50474-500
• Product Type: Human Prescription Drug
• Proprietary Name: Nayzilam
• Generic Name: Midazolam
• Dosage Form: Spray
• Route of Administration: NASAL
• Marketing Start Date: 2019-05-17
• Marketing Category: NDA / NDA
• Application Number: NDA211321
• Labeler Name: UCB, Inc.
• Substance Name: MIDAZOLAM
• Active Ingredient Strength: 5 mg/.1mL
• Pharm Classes: Benzodiazepine [EPC],Benzodiazepines [CS]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

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 Date: 2019-05-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50474-500-14 [50474050014]

Nayzilam SPRAY

• Marketing Category: NDA
• Application Number: NDA211321
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-17

NDC 50474-500-15 [50474050015]

Nayzilam SPRAY

• Marketing Category: NDA
• Application Number: NDA211321
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-17

Drug Details

Active Ingredients

Ingredient	Strength
MIDAZOLAM	5 mg/.1mL

OpenFDA Data

• SPL SET ID: 2b29422e-54d5-4a49-8522-e9cf752368c3
• Manufacturer:
  • UCB, Inc.
• UNII:
  • R60L0SM5BC

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
50474-500	Nayzilam	midazolam
0404-9912	Midazolam	Midazolam
0404-9913	Midazolam	Midazolam
0404-9915	Midazolam	Midazolam
0641-6056	Midazolam	Midazolam
0641-6057	Midazolam	Midazolam
0641-6059	Midazolam	Midazolam
0641-6060	Midazolam	Midazolam
0641-6061	Midazolam	Midazolam
0641-6063	Midazolam	Midazolam
0641-6190	Midazolam	Midazolam
0641-6209	Midazolam	Midazolam
0641-6210	Midazolam	Midazolam
0641-6211	Midazolam	Midazolam
50090-0683	Midazolam	Midazolam
50090-0738	Midazolam	Midazolam
51662-1236	MIDAZOLAM	MIDAZOLAM
51662-1237	MIDAZOLAM	MIDAZOLAM
51662-1324	MIDAZOLAM	MIDAZOLAM
52584-055	Midazolam	Midazolam
52584-056	Midazolam	Midazolam
52584-059	Midazolam	Midazolam
52584-081	Midazolam	Midazolam