61919-556 : Pentazocine Hydrochloride and Naloxone Hydrochloride Oral Tablet

NDC:	61919-556
Labeler:	Direct Rx
Product Type:	Human Prescription Drug
Drug Name:	Pentazocine Hydrochloride and Naloxone Hydrochloride
Dosage Form:	Oral Tablet
Application #:	ANDA075735
Rev. Date:	Jan 1, 2014
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:	NL;680
Shapes:	Capsule
Colors:	Yellow
Size (mm):	13
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.

NDC Package Codes:

• 61919-556-30: 30 TABLET IN 1 BOTTLE (61919‑556‑30)

Active Ingredients:

• Pentazocine Hydrochloride
• Naloxone Hydrochloride

Inactive Ingredients:

• Silicon Dioxide
• D&c Yellow No. 10
• Dibasic Calcium Phosphate Dihydrate
• Sodium Lauryl Sulfate
• Magnesium Stearate
• Cellulose, Microcrystalline
• Starch, Corn

Pharmaceutical Classes:

• Competitive Opioid Antagonists [MoA]
• Partial Opioid Agonist/Antagonist [EPC]
• Partial Opioid Agonists [MoA]
• Opioid Antagonist [EPC]
• Opioid Antagonists [MoA]

Related Products:

Based on records with the same trade name.

• 43386-680 Naloxone (As Naloxone Hydrochloride) 0.5 mg / Pentazocine (As Pentazocine Hydrochloride) 50 mg Oral Tablet by Gavis Pharmaceuticals, LLC

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