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 | 50458-513_072c13e0-7ea7-11e8-bdfb-43999d46d017 |
NDC | 50458-513 |
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 | 2020-06-30 |
Marketing Category | ANDA |
Application Number | ANDA085055 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 1977-08-17 |
Marketing End Date | 2018-10-31 |
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 |