0378-4005 : Alprazolam 1 mg Oral Tablet

NDC:	0378-4005
Labeler:	Mylan Pharmaceuticals Inc.
Product Type:	Human Prescription Drug
Drug Name:	Alprazolam
Dosage Form:	Oral Tablet
Application #:	ANDA074215
Rev. Date:	Sep 7, 2011
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:	MYLAN;A1
Shapes:	Round
Colors:	Blue
Size (mm):	7
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:

• 0378-4005-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0378‑4005‑01)
• 0378-4005-05: 500 TABLET IN 1 BOTTLE, PLASTIC (0378‑4005‑05)
• 0378-4005-77: 90 TABLET IN 1 BOTTLE, PLASTIC (0378‑4005‑77)

Active Ingredients:

• Alprazolam

Inactive Ingredients:

• Silicon Dioxide
• Croscarmellose Sodium
• Docusate Sodium
• Lactose Monohydrate
• Magnesium Stearate
• Cellulose, Microcrystalline
• Sodium Benzoate
• Sodium Lauryl Sulfate
• Fd&c Blue No. 2

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0378-4001 Alprazolam 0.25 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0378-4003 Alprazolam 0.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0378-4007 Alprazolam 2 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0378-5021 Alprazolam 0.5 mg 24 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
• 0378-5022 Alprazolam 1 mg 24 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
• 0378-5023 Alprazolam 2 mg 24 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
• 0378-5024 Alprazolam 3 mg 24 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
• 0054-3068 Alprazolam 1 mg/ml Oral Solution, Concentrate by Roxane Laboratories, Inc
• 0093-5450 Alprazolam 0.5 mg 24 Hr Extended Release Tablet by Teva Pharmaceuticals USA Inc
• 0093-5451 Alprazolam 1 mg 24 Hr Extended Release Tablet by Teva Pharmaceuticals USA Inc
• 0093-5452 Alprazolam 2 mg 24 Hr Extended Release Tablet by Teva Pharmaceuticals USA Inc
• 0093-5453 Alprazolam 3 mg 24 Hr Extended Release Tablet by Teva Pharmaceuticals USA Inc
• 0115-8311 Alprazolam 0.5 mg 24 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories Inc.
• 0115-8322 Alprazolam 1 mg 24 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories Inc.
• 0115-8333 Alprazolam 2 mg 24 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories Inc.
• 0115-8344 Alprazolam 3 mg 24 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories Inc.
• 0179-0093 Alprazolam 0.25 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-0094 Alprazolam 0.5 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-1964 Alprazolam .25 mg/1 Oral Tablet by Kaiser Foundation Hospitals
• 0179-1965 Alprazolam .5 mg/1 Oral Tablet by Kaiser Foundation Hospitals
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