0378-0477 : Diazepam 10 mg Oral Tablet

NDC:	0378-0477
Labeler:	Mylan Pharmaceuticals Inc.
Product Type:	Human Prescription Drug
Drug Name:	Diazepam
Dosage Form:	Oral Tablet
Application #:	ANDA070325
Rev. Date:	Nov 20, 2009
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;477
Shapes:	Round
Colors:	Green
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.

NDC Package Codes:

• 0378-0477-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0378‑0477‑01)
• 0378-0477-05: 500 TABLET IN 1 BOTTLE, PLASTIC (0378‑0477‑05)

Active Ingredients:

• Diazepam

Inactive Ingredients:

• Silicon Dioxide
• Magnesium Stearate
• Cellulose, Microcrystalline
• Starch, Corn
• Sodium Lauryl Sulfate
• Fd&c Blue No. 1
• D&c Yellow No. 10

Pharmaceutical Classes:

• Benzodiazepine [EPC]
• Benzodiazepines [CS]

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Based on records with the same trade name.

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