Prescription drug · NDA
Soma (carisoprodol) NDC 0037-2250
Carisoprodol 250 mg/1 · Tablet · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0037-2250-10 | 00037225010 | 100 TABLET in 1 BOTTLE, PLASTIC (0037-2250-10)Marketed from Sep 8, 2007 | |
| 0037-2250-30 | 00037225030 | 30 TABLET in 1 BOTTLE, PLASTIC (0037-2250-30)Marketed from Sep 8, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Soma
- Generic name (nonproprietary)
- carisoprodol
- Active ingredients
- Carisoprodol — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Viatris Specialty LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 011792
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 0037-2250_7272db18-d8cf-4bd0-ab9d-37e191a06f18SPL ID 7272db18-d8cf-4bd0-ab9d-37e191a06f18SPL set ID 6297cf20-830a-11dc-94c8-0002a5d5c51bRxCUI 197446, 213695, 730794, 730918UNII 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
N400037225010followed by a unit qualifier and the quantityPackage 00037-2250-10. 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 .
Indications (excerpt from the label)
SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use SOMA 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) ]. SOMA is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (1) Limitations of Use • Should only be used for acute treatment periods up to two or three weeks (1)
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 011792
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 250 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 51525-5901 |
| Somacarisoprodol | Carisoprodol 350 mg/1 | TabletOral | Viatris Specialty LLC | 0037-2001 |