Prescription drug · ANDA
carisoprodol NDC 68071-3421
Carisoprodol 350 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3421-6 | 68071342106 | 60 TABLET in 1 BOTTLE (68071-3421-6)Marketed from May 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
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040792
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 68071-3421_2d584ea9-407f-a440-e063-6294a90a48cdSPL ID 2d584ea9-407f-a440-e063-6294a90a48cdSPL set ID fd03c357-b199-c2b2-e053-6294a90abe2eRxCUI 197446UNII 21925K482HUPC 0368071342161
- 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
N468071342106followed by a unit qualifier and the quantityPackage 68071-3421-06. 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)
Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol tablets 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) ]. Carisoprodol is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (1) Limitation 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 ANDA 040792
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 | REMEDYREPACK INC. | 70518-3792 |
| carisoprodol | Carisoprodol 250 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-693 |
| carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9613 |
| carisoprodol | Carisoprodol 250 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-780 |
| carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-781 |
| carisoprodol | Carisoprodol 250 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-852 |
| carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-853 |
| carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-158 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Direct_Rx | 72189-386 |