Prescription drug · ANDA
Acetaminophen and Codeine Phosphate NDC 82804-283
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 |
|---|---|---|---|
| 82804-283-20 | 82804028320 | 20 TABLET in 1 BOTTLE (82804-283-20)Marketed from May 14, 2026 | |
| 82804-283-30 | 82804028330 | 30 TABLET in 1 BOTTLE (82804-283-30)Marketed from Apr 21, 2026 |
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 212418
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 82804-283_917e4926-1e60-473e-9ed8-b9abe08d83f1SPL ID 917e4926-1e60-473e-9ed8-b9abe08d83f1SPL set ID 6980bfc5-15e4-48ec-9346-6f09f8f78900RxCUI 993781UNII 362O9ITL9D, GSL05Y1MN6UPC 0382804283309
- 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
N482804028320followed by a unit qualifier and the quantityPackage 82804-0283-20. 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, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy (see WARNINGS ), reserve opioid analgesics, including acetaminophen and codeine phosphate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
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 30 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0529 |
| 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 | 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 |