13107-059 : Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet



NDC13107-059
Labeler: Aurolife Pharma, LLC
Product Type: Human Prescription Drug
Drug Name:  Acetaminophen and Codeine Phosphate
Dosage Form: Oral Tablet
Application #: ANDA202800
Rev. Date: 
DEA Schedule: CIII (US) [1]

NDC 13107-059 QR Code


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing less than 15 milligrams of Hydrocodone per dosage unit such as Vicodin, products containing not more than 90 milligrams of Codeine per dosage unit such as Tylenol with Codeine, other narcotics such as Suboxone, and non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: U36
Shapes:  Round
Colors: 
White
Size (mm): 11
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:

  • 13107-059-01: 100 TABLET IN 1 BOTTLE (13107‑059‑01)
  • 13107-059-01: 100 TABLET IN 1 BOTTLE (13107‑059‑01)
  • 13107-059-05: 500 TABLET IN 1 BOTTLE (13107‑059‑05)
  • 13107-059-05: 500 TABLET IN 1 BOTTLE (13107‑059‑05)
  • 13107-059-30: 30 TABLET IN 1 BOTTLE (13107‑059‑30)
  • 13107-059-30: 30 TABLET IN 1 BOTTLE (13107‑059‑30)
  • 13107-059-99: 1000 TABLET IN 1 BOTTLE (13107‑059‑99)
  • 13107-059-99: 1000 TABLET IN 1 BOTTLE (13107‑059‑99)

Active Ingredients:

  • Acetaminophen
  • Codeine Phosphate

Dosage Strength:

  • 300 mg
  • 30 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Croscarmellose Sodium
  • Crospovidone
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidone
  • Starch, Corn
  • Sodium Lauryl Sulfate
  • Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 13107-058 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Aurolife Pharma, LLC
  • 13107-060 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Aurolife Pharma, LLC
  • 0093-0050 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-0150 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-0350 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0121-0504 Acetaminophen and Codeine Phosphate Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-1008 Acetaminophen and Codeine Phosphate Oral Solution by Pharmaceutical Associates, Inc.
  • 0406-0483 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Mallinckrodt, Inc.
  • 0406-0484 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Mallinckrodt, Inc.
  • 0406-0485 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Mallinckrodt, Inc.
  • 0603-1020 Acetaminophen and Codeine Phosphate Oral Solution by Qualitest Pharmaceuticals
  • 0615-7792 Acetaminophen and Codeine Phosphate Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0785-6270 Apap 650 mg / Codeine Phosphate 60 mg Oral Tablet by Uad Laboratories
  • 10544-032 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 12634-266 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Apotheca, Inc.
  • 12634-267 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Apotheca, Inc.
  • 12634-526 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Apotheca, Inc.
  • 12634-975 Acetaminophen and Codeine Phosphate Oral Solution by Apotheca, Inc.
  • 16590-361 Acetaminophen and Codeine Phosphate Oral Solution by Stat Rx USA LLC
  • 17856-0079 Acetaminophen and Codeine Phosphate Oral Solution by Atlantic Biologicals Corps
  • More related products ...
< Prev: 13107-058Next: 13107-060 >

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