TYLENOL with Codeine
- Product NDC
- 50458-513
- 11-digit product format
- 504580513
- Labeler code
- 50458
- Product ID
- 50458-513_44171662-6387-11ea-b4d5-18e4fb2ca371
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- ANDA085055
- Marketing category
- ANDA
- Marketing start
- 1977-08-17
- Marketing end
- 2021-01-11
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-513-60 | EA - Each | 50458-513 | aa04767f-f8a3-4a22-ad01-f0f79845f202 | 1 | 2012-07-24 |
| 50458-513-80 | EA - Each | 50458-513 | 3a68e453-47c4-41d1-aa4f-bcb7c57d8ff9 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 160cd55a-a8ed-43f2-baf7-046d3c3b317f | 11 |
| 993837 | Tylenol with Codeine #3 30 MG / 300 MG Oral Tablet | PSN | 160cd55a-a8ed-43f2-baf7-046d3c3b317f | 11 |
| 993837 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet [Tylenol with Codeine] | SBD | 160cd55a-a8ed-43f2-baf7-046d3c3b317f | 11 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 160cd55a-a8ed-43f2-baf7-046d3c3b317f | 11 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 160cd55a-a8ed-43f2-baf7-046d3c3b317f | 11 |
| 993837 | APAP 300 MG / Codeine Phosphate 30 MG Oral Tablet [Tylenol with Codeine] | SY | 160cd55a-a8ed-43f2-baf7-046d3c3b317f | 11 |
| 993837 | Tylenol #3 Oral Tablet | SY | 160cd55a-a8ed-43f2-baf7-046d3c3b317f | 11 |
| 993837 | Tylenol with Codeine #3 (acetaminophen 300 MG / codeine phosphate 30 MG) Oral Tablet | SY | 160cd55a-a8ed-43f2-baf7-046d3c3b317f | 11 |
| 993837 | Tylenol with Codeine #3 (APAP 300 MG / codeine phosphate 30 MG) Oral Tablet | SY | 160cd55a-a8ed-43f2-baf7-046d3c3b317f | 11 |