0378-7103 : Apap 325 mg / Oxycodone Hydrochloride 2.5 mg Oral Tablet


NDC0378-7103
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Oxycodone and Acetaminophen
Dosage Form: Oral Tablet
Application #: ANDA090177
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: 103
Shapes:  Oval
Colors:  White
Size (mm): 14
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:

  • 0378-7103-01: 100 TABLET IN 1 BOTTLE (0378‑7103‑01)

Active Ingredients:

  • Acetaminophen
  • Oxycodone Hydrochloride

Dosage Strength:

  • 325 mg
  • 2.5 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Croscarmellose Sodium
  • Crospovidone
  • Cellulose, Microcrystalline
  • Povidones
  • Stearic Acid
  • Starch, Corn

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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.
  • 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
  • 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.
  • 0406-0523 Apap 325 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Mallinckrodt, Inc.
  • 0406-0532 Apap 500 mg / Oxycodone Hydrochloride 5 mg Oral Capsule by Mallinckrodt, Inc.
  • 0406-0582 Apap 500 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Mallinckrodt, Inc.
  • 0527-1669 Oxycodone and Acetaminophen Oral Tablet by Lannett Company, Inc.
  • 0527-1671 Oxycodone and Acetaminophen Oral Tablet by Lannett Company, Inc.
  • 0555-0658 Apap 500 mg / Oxycodone Hydrochloride 5 mg Oral Capsule by Barr Laboratories Inc.
  • 0591-0737 Apap 500 mg / Oxycodone Hydrochloride 5 mg Oral Capsule by Watson Laboratories, Inc.
  • 0591-0749 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Watson Laboratories, Inc.
  • More related products ...

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 0378-7103 QR Code

< Prev: 0378-7101Next: 0378-7104 >

Related Discussions:

oxycodone acetaminophen 10 325 changes
I HAVE OA AND need both knees and right hip replaced, I also have bone infarcts in both legs and in 2003 had a car accid... 8 replies
oxycodone acetaminophen 10 325 mg What is the time limit for the drug store to fill this prescription.
Oxycodone Acetamnophen 10 325MG TB What is the time limited for the drug store to fill this prescription. ## Hello, Ann!... 6 replies
Oxycodone Acetaminophen 5 325 and still in pain
I had a total knee replacement done last Monday. When released on Thursday, I was prescribed with Oxycodone Acetaminophe... 5 replies
oxycodone acetaminophen7. 5/ 325 tab all brands reactions
I need to know about this medicine. I have been taking Oxycodone-APAP 7.5/325 mg (Mallin). Last month the pharmacy chang... 4 replies
Oxycodone Acetaminophen 7 5 325
What does the oxycodone-acetaminophe 7.5-325 tab manufactured by alvogen look like? The one I have is round and peach in... 4 replies
oxycodone acetaminophen shortage? in severe pain
I'm on pain management for 3 bulging now possibly herniated discs(I have to get a new MRI and EMG This week) and a k... 4 replies
Oxycodone acetaminophen 5/325 affect breathing?
Does this affect your breathing and what is the 5 mixture? ## Hello, K! How are you? This is 5mgs of Oxycodone coupled w... 3 replies
oxycodone acetaminophen 5 325mg does it contain aspirin
I would like to know if aspirin is in oxycodone. My husband has back pain and I have oxycodone/acetaminophen5-325 I use ... 3 replies
oxycodone acetaminophen 10 325 mg /hydrocodone 10-325
I was taking hydrocodon 10-325 and now my dr switched me to Percocet 10-325 and when I take it it puts me to sleep for h... 2 replies
Oxycodone Acetaminophen 10 325 6x a day
I have been on Oxycodone 10/325 for over three years, taking 6 per day. My doctor wants to change what would be comparab... 2 replies




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.