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TYLENOL with Codeine - 50458-513-60 - (acetaminophen and codeine phosphate)

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Drug Information of TYLENOL with Codeine

Product NDC: 50458-513
Proprietary Name: TYLENOL with Codeine
Non Proprietary Name: acetaminophen and codeine phosphate
Active Ingredient(s): 300; 30    mg/1; mg/1 & nbsp;   acetaminophen and codeine phosphate
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of TYLENOL with Codeine

Product NDC: 50458-513
Labeler Name: Janssen Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA085055
Marketing Category: ANDA
Start Marketing Date: 19770817

Package Information of TYLENOL with Codeine

Package NDC: 50458-513-60
Package Description: 100 TABLET in 1 BOTTLE (50458-513-60)

NDC Information of TYLENOL with Codeine

NDC Code 50458-513-60
Proprietary Name TYLENOL with Codeine
Package Description 100 TABLET in 1 BOTTLE (50458-513-60)
Product NDC 50458-513
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name acetaminophen and codeine phosphate
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 19770817
Marketing Category Name ANDA
Labeler Name Janssen Pharmaceuticals, Inc.
Substance Name ACETAMINOPHEN; CODEINE PHOSPHATE
Strength Number 300; 30
Strength Unit mg/1; mg/1
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of TYLENOL with Codeine


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