Prescription drug · ANDA
Acetaminophen and Codeine Phosphate NDC 80425-0529
Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0529-1 | 80425052901 | 30 TABLET in 1 BOTTLE (80425-0529-1)Marketed from Jun 2, 2025 | |
| 80425-0529-2 | 80425052902 | 60 TABLET in 1 BOTTLE (80425-0529-2)Marketed from Jun 2, 2025 | |
| 80425-0529-3 | 80425052903 | 90 TABLET in 1 BOTTLE (80425-0529-3)Marketed from Jun 2, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212418
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 80425-0529_3698e0ff-6a1d-e1ad-e063-6294a90a163aSPL ID 3698e0ff-6a1d-e1ad-e063-6294a90a163aSPL set ID 3698e0ff-6a1c-e1ad-e063-6294a90a163aRxCUI 993781, 993890UNII GSL05Y1MN6, 362O9ITL9D
- 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
N480425052901followed by a unit qualifier and the quantityPackage 80425-0529-01. 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 or opioid combination products]: Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia Acetamin…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212418
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 | Advanced Rx of Tennessee, LLC | 80425-0530 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Proficient Rx LP | 82804-283 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3798 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-643 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-641 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-642 |