54348-066 : Hydrocodone/Apap Oral Tablet


NDC54348-066
Labeler: Pharmpak, Inc.
Product Type: Human Prescription Drug
Drug Name: Hydrocodone/Apap
Dosage Form: Oral Tablet
Application #: ANDA040736
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;109
Shapes:  Oval
Colors:  White
Size (mm): 10
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

  • 54348-066-01: 1 BLISTER PACK IN 1 BOX (54348‑066‑01) > 1 TABLET IN 1 BLISTER PACK
  • 54348-066-10: 10 TABLET IN 1 BOTTLE (54348‑066‑10)

Active Ingredients:

  • Acetaminophen
  • Hydrocodone Bitartrate

Dosage Strength:

  • 325 mg
  • 5 mg

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 54348-013 Hydrocodone/Apap Oral Tablet by Pharmpak, Inc.
  • 61919-618 Hydrocodone /Apap Oral Tablet by Directrx
  • 72189-352 Hydrocodone Apap Oral Tablet by Direct_rx

NDC QR Code

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NDC 54348-066 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.