Prescription drug · ANDA
Acetaminophen And Codeine NDC 61919-484
Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-484-90 | 61919048490 | 90 TABLET in 1 BOTTLE (61919-484-90)Marketed from Jul 12, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Acetaminophen And Codeine
- Generic name (nonproprietary)
- acetaminophen and codeine
- Active ingredients
- Acetaminophen — 300 mg/1Codeine phosphate — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040419
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 61919-484_33efe999-f08a-baf6-e063-6294a90a54f2SPL ID 33efe999-f08a-baf6-e063-6294a90a54f2SPL set ID 8d7ca633-4448-3507-e053-2a95a90a1287RxCUI 993781UNII 362O9ITL9D, GSL05Y1MN6
- Pharmacologic class
- Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461919048490followed by a unit qualifier and the quantityPackage 61919-0484-90. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) Have not provided adequate analgesia, or are not expected to provide adequate analgesia, Have not been tolerated, or are not expected to be tolerated.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040419
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3031 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-009 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4475 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4533 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1 | TabletOral | SpecGx LLC | 0406-0483 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | SpecGx LLC | 0406-0484 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | SpecGx LLC | 0406-0485 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Quality Care Products, LLC | 49999-060 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1522 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-0485 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5666 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-4610 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-4611 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-4484 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-003 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7835 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-002 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Proficient Rx LP | 63187-106 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7859 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-581 |
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