43063-279 : Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet


NDC: 43063-279
Labeler: Pd-rx Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Oxycodone and Acetaminophen
Dosage Form: Oral Tablet
Application #: ANDA040105
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: 4839;V
Shapes:  Round
Colors:  White
Size (mm): 12
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.

4839 V: (0603-4998) Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 43063-279-04: 4 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑04)
  • 43063-279-06: 6 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑06)
  • 43063-279-10: 10 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑10)
  • 43063-279-12: 12 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑12)
  • 43063-279-18: 18 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑18)
  • 43063-279-20: 20 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑20)
  • 43063-279-24: 24 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑24)
  • 43063-279-30: 30 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑30)
  • 43063-279-40: 40 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑40)
  • 43063-279-60: 60 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑60)
  • 43063-279-90: 90 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑90)
  • 43063-279-93: 180 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑93)
  • 43063-279-98: 120 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑98)
  • 43063-279-99: 240 TABLET IN 1 BOTTLE, PLASTIC (43063‑279‑99)

Active Ingredients:

  • Oxycodone Hydrochloride
  • Acetaminophen

Dosage Strength:

  • 5 mg
  • 325 mg

Inactive Ingredients:

  • Crospovidone
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidone
  • Starch, Pregelatinized Corn
  • Sodium Starch Glycolate Type a Potato
  • Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 43063-231 Apap 325 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-379 Apap 325 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-523 Oxycodone and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-528 Oxycodone and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-653 Oxycodone and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-809 Oxycodone and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 55289-951 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 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.
  • 0378-7105 Apap 325 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-7106 Apap 325 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-7107 Apap 500 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-7108 Apap 650 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0406-0512 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Mallinckrodt, Inc.
  • 0406-0522 Apap 325 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Mallinckrodt, Inc.
  • More related products ...

NDC QR Code

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NDC 43063-279 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.