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Oxycodone and Acetaminophen - 0378-7108-01 - (Oxycodone hydrochloride and Acetaminophen)

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Drug Information of Oxycodone and Acetaminophen

Product NDC: 0378-7108
Proprietary Name: Oxycodone and Acetaminophen
Non Proprietary Name: Oxycodone hydrochloride and Acetaminophen
Active Ingredient(s): 650; 10    mg/1; mg/1 & nbsp;   Oxycodone hydrochloride and Acetaminophen
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Oxycodone and Acetaminophen

Product NDC: 0378-7108
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090177
Marketing Category: ANDA
Start Marketing Date: 20081216

Package Information of Oxycodone and Acetaminophen

Package NDC: 0378-7108-01
Package Description: 100 TABLET in 1 BOTTLE (0378-7108-01)

NDC Information of Oxycodone and Acetaminophen

NDC Code 0378-7108-01
Proprietary Name Oxycodone and Acetaminophen
Package Description 100 TABLET in 1 BOTTLE (0378-7108-01)
Product NDC 0378-7108
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Oxycodone hydrochloride and Acetaminophen
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20081216
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength Number 650; 10
Strength Unit mg/1; mg/1
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of Oxycodone and Acetaminophen


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