Prescription drug · ANDA
Acetaminophen And Codeine Phosphate NDC 63629-3031
Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-3031-0 | 6362930310063629303100 | 100 TABLET in 1 BOTTLE (63629-3031-0)Marketed from Mar 25, 2021 | |
| 63629-3031-1 | 6362930310163629303101 | 30 TABLET in 1 BOTTLE (63629-3031-1)Marketed from Jul 18, 2006 | |
| 63629-3031-2 | 6362930310263629303102 | 120 TABLET in 1 BOTTLE (63629-3031-2)Marketed from Feb 2, 2006 | |
| 63629-3031-3 | 6362930310363629303103 | 60 TABLET in 1 BOTTLE (63629-3031-3)Marketed from Jul 18, 2006 | |
| 63629-3031-4 | 6362930310463629303104 | 90 TABLET in 1 BOTTLE (63629-3031-4)Marketed from Jan 3, 2007 | |
| 63629-3031-5 | 6362930310563629303105 | 40 TABLET in 1 BOTTLE (63629-3031-5)Marketed from Apr 29, 2009 | |
| 63629-3031-6 | 6362930310663629303106 | 20 TABLET in 1 BOTTLE (63629-3031-6)Marketed from Mar 1, 2011 | |
| 63629-3031-7 | 6362930310763629303107 | 112 TABLET in 1 BOTTLE (63629-3031-7)Marketed from Feb 15, 2012 | |
| 63629-3031-8 | 6362930310863629303108 | 84 TABLET in 1 BOTTLE (63629-3031-8)Marketed from Feb 15, 2012 | |
| 63629-3031-9 | 6362930310963629303109 | 15 TABLET in 1 BOTTLE (63629-3031-9)Marketed from Feb 9, 2022 |
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 — 60 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040419
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 63629-3031_761159a0-fffc-43ca-b8bf-66f205460960SPL ID 761159a0-fffc-43ca-b8bf-66f205460960SPL set ID 18315a6f-9e89-46d7-81d3-905b8a51aa79RxCUI 993890UNII 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
N463629303100followed by a unit qualifier and the quantityPackage 63629-3031-00. 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, 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) Have not provided adequate analgesia, or are not expected to provide adequate analgesia, Have not been tolerated, or are not expected to be tolerated. Acetaminophen and codeine phosphate t…
Excerpt only. Read the full label for complete information.
About NDC 63629-3031
- What is NDC 63629-3031?
- 63629-3031 is the product NDC for Acetaminophen And Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 040419
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 | Clinical Solutions Wholesale, LLC | 58118-0485 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1522 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-4484 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7835 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | A-S Medication Solutions | 50090-3011 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Proficient Rx LP | 63187-106 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7859 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1 | TabletOral | SpecGx LLC | 0406-0483 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-002 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-003 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | SpecGx LLC | 0406-0484 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-009 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-581 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-4610 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3705 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | SpecGx LLC | 0406-0485 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-4611 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4475 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4533 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Direct_Rx | 72189-376 |
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