Prescription drug · ANDA
Acetaminophen And Codeine Phosphate NDC 76420-821
Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-821-00 | 76420082100 | 100 TABLET in 1 BOTTLE (76420-821-00)Marketed from Jul 1, 2024 | |
| 76420-821-01 | 76420082101 | 1 TABLET in 1 BOTTLE (76420-821-01)Marketed from Jul 1, 2024 | |
| 76420-821-03 | 76420082103 | 3 TABLET in 1 BOTTLE (76420-821-03)Marketed from Jul 1, 2024 | |
| 76420-821-05 | 76420082105 | 5 TABLET in 1 BOTTLE (76420-821-05)Marketed from Jul 1, 2024 | |
| 76420-821-10 | 76420082110 | 10 TABLET in 1 BOTTLE (76420-821-10)Marketed from Jul 1, 2024 | |
| 76420-821-12 | 76420082112 | 12 TABLET in 1 BOTTLE (76420-821-12)Marketed from Jul 1, 2024 | |
| 76420-821-15 | 76420082115 | 15 TABLET in 1 BOTTLE (76420-821-15)Marketed from Jul 1, 2024 | |
| 76420-821-20 | 76420082120 | 20 TABLET in 1 BOTTLE (76420-821-20)Marketed from Jul 1, 2024 | |
| 76420-821-24 | 76420082124 | 24 TABLET in 1 BOTTLE (76420-821-24)Marketed from Aug 17, 2025 | |
| 76420-821-30 | 76420082130 | 30 TABLET in 1 BOTTLE (76420-821-30)Marketed from Jul 1, 2024 | |
| 76420-821-50 | 76420082150 | 500 TABLET in 1 BOTTLE (76420-821-50)Marketed from Jul 1, 2024 | |
| 76420-821-60 | 76420082160 | 60 TABLET in 1 BOTTLE (76420-821-60)Marketed from Jul 1, 2024 | |
| 76420-821-90 | 76420082190 | 90 TABLET in 1 BOTTLE (76420-821-90)Marketed from Jul 1, 2024 |
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
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211610
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 76420-821_3c8f10b4-0551-c65f-e063-6294a90a3543SPL ID 3c8f10b4-0551-c65f-e063-6294a90a3543SPL set ID 682ef287-647a-4d89-9bbf-75907ebd10f2RxCUI 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
N476420082100followed by a unit qualifier and the quantityPackage 76420-0821-00. 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, 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 211610
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 | Bryant Ranch Prepack | 71335-1818 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3651 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1846 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3658 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1190 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8882 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Redpharm Drug | 67296-2239 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2002 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2001 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2628 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2764 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Eywa Pharma Inc | 71930-056 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1 | TabletOral | Eywa Pharma Inc | 71930-054 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Eywa Pharma Inc | 71930-055 |