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TYLENOL with Codeine
TYLENOL with Codeine - 50458-513-80 - (acetaminophen and codeine phosphate)
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: | 50458-513-80 |
| Package Description: | 1000 TABLET in 1 BOTTLE (50458-513-80) |
NDC Information of TYLENOL with Codeine
| NDC Code | 50458-513-80 |
| Proprietary Name | TYLENOL with Codeine |
| Package Description | 1000 TABLET in 1 BOTTLE (50458-513-80) |
| 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] |
