61919-053 : Acetaminophen and Codeine Phosphate Oral Tablet


NDC: 61919-053
Labeler: Direct Rx
Product Type: Human Prescription Drug
Drug Name: Acetaminophen and Codeine Phosphate
Dosage Form: Oral Tablet
Application #: ANDA202800
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: 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:

  • 61919-053-30: 30 TABLET IN 1 BOTTLE (61919‑053‑30)
  • 61919-053-60: 60 TABLET IN 1 BOTTLE (61919‑053‑60)
  • 61919-053-71: 100 TABLET IN 1 BOTTLE (61919‑053‑71)

Active Ingredients:

  • Acetaminophen
  • Codeine Phosphate

Dosage Strength:

  • 30 mg
  • 300 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Croscarmellose Sodium
  • Stearic Acid
  • Povidone
  • Silicon Dioxide
  • Crospovidone (15 Mpa.s At 5%)
  • Magnesium Stearate
  • Starch, Corn
  • Sodium Lauryl Sulfate /
  • Crospovidone (120 .mu.m)
  • Magnesium Stearate
  • Starch, Corn
  • Stearic Acid
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Povidone
  • Cellulose, Microcrystalline
  • Sodium Lauryl Sulfate /
  • Sodium Lauryl Sulfate
  • Stearic Acid
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Crospovidone (15 Mpa.s At 5%)
  • Magnesium Stearate
  • Starch, Corn
  • Povidone
  • Cellulose, Microcrystalline

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 61919-328 Acetaminophen and Codeine Phosphate Oral Tablet by Direct Rx
  • 61919-273 Acetaminophen and Codeine Phosphate Oral Tablet by Directrx
  • 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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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.