Prescription drug · ANDA
Acetaminophen and Codeine NDC 65162-033
Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-033-10 | 65162003310 | 100 TABLET in 1 BOTTLE (65162-033-10)Marketed from May 29, 2008 | |
| 65162-033-11 | 65162003311 | 1000 TABLET in 1 BOTTLE (65162-033-11)Marketed from May 29, 2008 | |
| 65162-033-50 | 65162003350 | 500 TABLET in 1 BOTTLE (65162-033-50)Marketed from May 29, 2008 |
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
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040779
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 65162-033_75a6d334-42b8-44d0-a4a1-fd3eeb95008fSPL ID 75a6d334-42b8-44d0-a4a1-fd3eeb95008fSPL set ID 8bc4108b-314e-4a52-a37c-631c6b869b04RxCUI 993781UNII 362O9ITL9D, GSL05Y1MN6UPC 0365162033106
- 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
N465162003310followed by a unit qualifier and the quantityPackage 65162-0033-10. 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 040779
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 | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0545 |
| Acetaminophen and Codeine | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Proficient Rx LP | 63187-491 |
| Acetaminophen and Codeine | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-103 |
| Acetaminophen and Codeine | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | RedPharm Drug, Inc. | 67296-1772 |