64850-643 : Acetaminophen and Codeine Phosphate Oral Tablet


NDC: 64850-643
Labeler: Elite Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name: Acetaminophen and Codeine Phosphate
Dosage Form: Oral Tablet
Application #: ANDA212418
Rev. Date: 
CSA Schedule: CIII (US) [1]


[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 not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 4;ECA
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:

  • 64850-643-10: 100 TABLET IN 1 BOTTLE (64850‑643‑10)
  • 64850-643-12: 120 TABLET IN 1 BOTTLE (64850‑643‑12)

Active Ingredients:

  • Acetaminophen
  • Codeine Phosphate

Dosage Strength:

  • 300 mg
  • 60 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Magnesium Stearate
  • Cellulose, Microcrystalline /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 64850-641 Acetaminophen and Codeine Phosphate Oral Tablet by Elite Laboratories, Inc.
  • 64850-642 Acetaminophen and Codeine Phosphate Oral Tablet by Elite Laboratories, Inc.
  • 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
  • 0615-8102 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.
  • 13107-058 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Aurolife Pharma, LLC
  • More related products ...

NDC QR Code

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