Prescription drug · ANDA
Acetaminophen and Codeine Phosphate NDC 82804-181
Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-181-30 | 82804018130 | 30 TABLET in 1 BOTTLE (82804-181-30)Marketed from Jan 2, 2025 |
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 Phosphate
- Generic name (nonproprietary)
- acetaminophen and codeine phosphate
- Active ingredients
- Acetaminophen — 300 mg/1Codeine phosphate — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089805
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 82804-181_5d9123f6-b322-4fa0-bf48-6335a6adcbb8SPL ID 5d9123f6-b322-4fa0-bf48-6335a6adcbb8SPL set ID 5d9123f6-b322-4fa0-bf48-6335a6adcbb8RxCUI 993781UNII 362O9ITL9D, GSL05Y1MN6UPC 0382804181308
- 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
N482804018130followed by a unit qualifier and the quantityPackage 82804-0181-30. 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)
INDICATIONS AND USAGE 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, which can occur at any dosage or duration [see Warnings] , reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). • Have not been tolerated or are not expected to be tolerated, • Have not provided adequate analgesia or are not expected to provide adequate analgesia Acetaminophen and codeine phosphate…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 089805
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 30 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-446 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2916 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0527 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-938 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4104 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3824 |