68084-393 : Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet


NDC68084-393
Labeler: American Health Packaging
Product Type: Human Prescription Drug
Drug Name:  Propoxyphene Napsylate and Acetaminophen
Dosage Form: Oral Tablet
Application #: ANDA074843
Rev. Date: 
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: 5114;V
Shapes:  Oval
Colors:  Pink
Size (mm): 19
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:

  • 68084-393-01: 10 BLISTER PACK IN 1 CARTON (68084‑393‑01) > 10 TABLET IN 1 BLISTER PACK (68084‑393‑11)

Active Ingredients:

  • Acetaminophen
  • Propoxyphene Napsylate

Dosage Strength:

  • 650 mg
  • 100 mg

Inactive Ingredients:

  • Carnauba Wax
  • Hypromellose
  • Lactose Monohydrate
  • Magnesium Stearate
  • Polyethylene Glycol
  • Polysorbate 80
  • Sodium Starch Glycolate Type a Potato
  • Titanium Dioxide
  • D&c Yellow No. 10
  • Fd&c Red No. 40

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 0378-0155 Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet by Mylan Pharmaceuticals Inc.
  • 10544-513 Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet by Blenheim Pharmacal, Inc.
  • 12634-537 Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet by Apotheca, Inc.
  • 21695-280 Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet by Rebel Distributors Corp.
  • 49349-159 Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet by Remedyrepack Inc.
  • 49999-767 Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet by Lake Erie Medical Dba Quality Care Products
  • 63629-1344 Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet by Bryant Ranch Prepack
  • 67296-0104 Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet by Redpharm Drug Inc.
  • 67296-0105 Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet by Redpharm Drug Inc.
  • 67296-0378 Apap 650 mg / Propoxyphene Napsylate 100 mg (Propoxyphene Hydrochloride 65 mg) Oral Tablet by Redpharm Drug Inc.

NDC QR Code

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