0378-0211 : Amitriptyline Hydrochloride 12.5 mg / Chlordiazepoxide 5 mg Oral Tablet

NDC:	0378-0211
Labeler:	Mylan Pharmaceuticals Inc.
Product Type:	Human Prescription Drug
Drug Name:	Chlordiazepoxide and Amitriptyline Hydrochloride
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA071297
Rev. Date:	Dec 10, 1986
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;211
Shapes:	Round
Colors:	Green
Size (mm):	10
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

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:

• 0378-0211-01: 100 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑0211‑01)
• 0378-0211-05: 500 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑0211‑05)

Active Ingredients:

• Chlordiazepoxide
• Amitriptyline Hydrochloride

Inactive Ingredients:

• Silicon Dioxide
• Croscarmellose Sodium
• Hydroxypropyl Cellulose
• Hypromellose
• Magnesium Stearate
• Cellulose, Microcrystalline
• Polyethylene Glycol
• Starch, Corn
• Sodium Lauryl Sulfate
• Titanium Dioxide
• D&c Yellow No. 10
• Fd&c Blue No. 1
• Fd&c Yellow No. 6

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0378-0277 Amitriptyline Hydrochloride 25 mg / Chlordiazepoxide 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 42571-302 Chlordiazepoxide and Amitriptyline Hydrochloride Oral Tablet by Micro Labs Limited
• 42571-303 Chlordiazepoxide and Amitriptyline Hydrochloride Oral Tablet by Micro Labs Limited

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