TYLENOL with Codeine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Acetaminophen; Codeine Phosphate.
| Product ID | 50458-515_072c13e0-7ea7-11e8-bdfb-43999d46d017 |
| NDC | 50458-515 |
| Product Type | Human Prescription Drug |
| Proprietary Name | TYLENOL with Codeine |
| Generic Name | Acetaminophen And Codeine Phosphate |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 1977-08-17 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA085055 |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE |
| Active Ingredient Strength | 300 mg/1; mg/1 |
| Pharm Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule | CIII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 1977-08-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA085055 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 1977-08-17 |
| Marketing End Date | 2020-02-28 |
| Marketing Category | ANDA |
| Application Number | ANDA085055 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 1977-08-17 |
| Marketing End Date | 2020-02-28 |
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 300 mg/1 |
| SPL SET ID: | 936e481e-f46c-4e03-b8e3-25961cda1909 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50090-0006 | TYLENOL with Codeine | TYLENOL with Codeine |
| 50458-515 | TYLENOL with Codeine | TYLENOL with Codeine |
| 50458-513 | TYLENOL with Codeine | TYLENOL with Codeine |
| 0440-7026 | Acetaminophen And Codeine | acetaminophen and codeine phosphate |
| 0440-7027 | Acetaminophen And Codeine | acetaminophen and codeine phosphate |
| 0603-2337 | Acetaminophen And Codeine | acetaminophen and codeine phosphate |
| 0603-2338 | Acetaminophen And Codeine | acetaminophen and codeine phosphate |
| 0093-0050 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate |
| 0093-0150 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate |
| 0093-0350 | Acetaminophen and Codeine Phosphate | Acetaminophen and Codeine Phosphate |
| 0121-0504 | Acetaminophen and Codeine Phosphate | ACETAMINOPHEN and CODEINE PHOSPHATE |
| 0406-0483 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate |
| 0406-0484 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate |
| 0406-0485 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate |