21695-634 : Apap 650 mg / Pentazocine (As Pentazocine Hydrochloride) 25 mg Oral Tablet

NDC:	21695-634
Labeler:	Rebel Distributors Corp
Product Type:	Human Prescription Drug
Drug Name:	Pentazocine Hcl and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA074699
Rev. Date:	Mar 24, 2000
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:	396;25;650;WATSON
Shapes:	Oval
Colors:	Blue
Size (mm):	19
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:

• 21695-634-60: 60 TABLET IN 1 BOTTLE (21695‑634‑60)

Active Ingredients:

• Acetaminophen
• Pentazocine Hydrochloride

Inactive Ingredients:

• Silicon Dioxide
• Crospovidone
• D&c Yellow No. 10
• Fd&c Blue No. 1
• Cellulose, Microcrystalline
• Povidone
• Starch, Corn
• Sodium Starch Glycolate Type a Potato
• Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0591-0396 Apap 650 mg / Pentazocine (As Pentazocine Hydrochloride) 25 mg Oral Tablet by Watson Laboratories, Inc.

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