18860-322 : Niravam 0.5 mg Disintegrating Tablet

NDC:	18860-322
Labeler:	Jazz Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Niravam
Dosage Form:	Oral Tablet, Orally Disintegrating
Application #:	NDA021726
Rev. Date:	Apr 1, 2005
CSA Schedule:	CIV (US) [1]

^[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	SP;322;05
Shapes:	Round
Colors:	Yellow
Size (mm):	8
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 18860-322-01: 100 TABLET, ORALLY DISINTEGRATING IN 1 BOTTLE (18860‑322‑01)

Active Ingredients:

• Alprazolam

Inactive Ingredients:

• Silicon Dioxide
• Starch, Corn
• Crospovidone
• Magnesium Stearate
• Mannitol
• Cellulose, Microcrystalline
• Sucralose
• Sucrose
• Ferric Oxide Yellow
• Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer

Pharmaceutical Classes:

• Benzodiazepine [EPC]
• Benzodiazepines [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.

• 18860-321 Niravam 0.25 mg Disintegrating Tablet by Jazz Pharmaceuticals, Inc.
• 18860-323 Niravam 1 mg Disintegrating Tablet by Jazz Pharmaceuticals, Inc.
• 18860-324 Niravam 2 mg Disintegrating Tablet by Jazz Pharmaceuticals, Inc.
• 0091-3321 Niravam 0.25 mg Disintegrating Tablet by Schwarz Pharma Inc.
• 0091-3322 Niravam 0.5 mg Disintegrating Tablet by Schwarz Pharma Inc.
• 0091-3323 Niravam 1 mg Disintegrating Tablet by Schwarz Pharma Inc.
• 0091-3324 Niravam 2 mg Disintegrating Tablet by Schwarz Pharma Inc.
• 16590-938 Niravam 0.5 mg Disintegrating Tablet by Stat Rx USA LLC

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