Prescription drug · ANDA
Acetaminophen And Codeine Phosphate NDC 67296-2239
Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 · Tablet · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2239-2 | 6729622390267296223902 | 6 TABLET in 1 BOTTLE (67296-2239-2)Marketed from Aug 2, 2019 | |
| 67296-2239-5 | 6729622390567296223905 | 15 TABLET in 1 BOTTLE (67296-2239-5)Marketed from Aug 2, 2019 |
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
- Labeler
- Redpharm DrugNDC labeler code 67296
- 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 67296-2239_52616ece-c675-6f7e-e063-6294a90acbb6SPL ID 52616ece-c675-6f7e-e063-6294a90acbb6SPL set ID 52617668-acc3-65cd-e063-6294a90ab919RxCUI 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
N467296223902followed by a unit qualifier and the quantityPackage 67296-2239-02. 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 codeine phosphate 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.
About NDC 67296-2239
- What is NDC 67296-2239?
- 67296-2239 is the product NDC for Acetaminophen And Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Redpharm Drug. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen And Codeine Phosphate.
- What is the active ingredient?
- Acetaminophen, Codeine phosphate.
- Who is the labeler?
- Redpharm Drug, NDC labeler code 67296. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen And Codeine Phosphate?
- 67 other product NDCs are listed under this name. See all Acetaminophen And Codeine Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen And Codeine Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-009 | 87441-0009-01 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8881 | 68788-8881-0168788-8881-0368788-8881-06 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8882 | 68788-8882-0168788-8882-0368788-8882-06 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0527 | 80425-0527-0180425-0527-0280425-0527-03 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0528 | 80425-0528-0180425-0528-0280425-0528-03 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0529 | 80425-0529-0180425-0529-0280425-0529-03 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0530 | 80425-0530-0180425-0530-0280425-0530-03 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4104 | 70518-4104-00 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-938 | 60760-0938-30 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-446 | 64380-0446-0164380-0446-0264380-0446-03 |
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 | 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 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2001 |
| 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 | Asclemed USA, Inc. | 76420-821 |
| 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 |
| 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 30 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3651 |
| 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 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1818 |
| 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 60 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1846 |