Prescription drug · ANDA
Carisoprodol NDC 80425-0291
Carisoprodol 350 mg/1 · Tablet · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0291-1 | 80425029101 | 30 TABLET in 1 BOTTLE (80425-0291-1)Marketed from Mar 31, 2023 | |
| 80425-0291-2 | 80425029102 | 60 TABLET in 1 BOTTLE (80425-0291-2)Marketed from Mar 31, 2023 | |
| 80425-0291-3 | 80425029103 | 90 TABLET in 1 BOTTLE (80425-0291-3)Marketed from Mar 31, 2023 |
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)
- Carisoprodol
- Generic name (nonproprietary)
- carisoprodol
- Active ingredients
- Carisoprodol — 350 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203374
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 80425-0291_2a9bf7d3-46d8-0dfa-e063-6394a90a76a4SPL ID 2a9bf7d3-46d8-0dfa-e063-6394a90a76a4SPL set ID f835e66e-f3f3-c3cf-e053-6294a90addf2RxCUI 197446UNII 21925K482H
- Pharmacologic class
- Muscle Relaxant
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
N480425029101followed by a unit qualifier and the quantityPackage 80425-0291-01. 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 .
Indications (excerpt from the label)
1. Indications and Usage Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [ see DOSAGE AND ADMINISTRATION (2)]
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203374
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 |
|---|---|---|---|---|
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5075 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-109 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8477 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8478 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8479 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Proficient Rx LP | 71205-339 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-646 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-062 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Vensun Pharmaceuticals, Inc. | 42543-700 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1524 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Direct_Rx | 61919-878 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1203 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Proficient Rx LP | 71205-241 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-397 |