35356-840 : Apap 650 mg / Oxycodone Hydrochloride 10 mg Oral Tablet


NDC35356-840
Labeler: Lake Erie Medical Dba Quality Care Products LLC
Product Type: Human Prescription Drug
Drug Name:  Oxycodone and Acetaminophen
Dosage Form: Oral Tablet
Application #: ANDA040789
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: IP;206
Shapes:  Capsule
Colors:  White
Size (mm): 20
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:

  • 35356-840-30: 30 TABLET IN 1 BOTTLE (35356‑840‑30)
  • 35356-840-60: 60 TABLET IN 1 BOTTLE (35356‑840‑60)
  • 35356-840-90: 90 TABLET IN 1 BOTTLE (35356‑840‑90)

Active Ingredients:

  • Acetaminophen
  • Oxycodone

Dosage Strength:

  • 650 mg
  • 10 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Crospovidone
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidone
  • Starch, Corn
  • Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 35356-063 Apap 500 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-817 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-937 Apap 325 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-801 Apap 325 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Lake Erie Medical Dba Quality Care Product S LLC
  • 35356-802 Apap 325 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Lake Erie Medical Dba Quality Care Product S LLC
  • 49999-852 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 49999-854 Apap 325 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-373 Oxycodone and Acetaminophen Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-385 Oxycodone and Acetaminophen Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-496 Oxycodone and Acetaminophen Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-497 Oxycodone and Acetaminophen Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-498 Oxycodone and Acetaminophen Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-658 Oxycodone and Acetaminophen Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 0054-0551 Oxycodone and Acetaminophen Oral Tablet by Roxane Laboratories, Inc.
  • 0228-2980 Oxycodone and Acetaminophen Oral Tablet by Actavis Elizabeth LLC
  • 0228-2981 Oxycodone and Acetaminophen Oral Tablet by Actavis Elizabeth LLC
  • 0228-2982 Oxycodone and Acetaminophen Oral Tablet by Actavis Elizabeth LLC
  • 0228-2983 Oxycodone and Acetaminophen Oral Tablet by Actavis Elizabeth LLC
  • 0378-7103 Apap 325 mg / Oxycodone Hydrochloride 2.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-7104 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 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.