Prescription drug · ANDA
Carisoprodol NDC 72789-190
Carisoprodol 350 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-190-14 | 72789019014 | 14 TABLET in 1 BOTTLE, PLASTIC (72789-190-14)Marketed from May 26, 2021 | |
| 72789-190-30 | 72789019030 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-190-30)Marketed from May 20, 2021 | |
| 72789-190-98 | 72789019098 | 120 TABLET in 1 BOTTLE, PLASTIC (72789-190-98)Marketed from Aug 3, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Carisoprodol
- Generic name (nonproprietary)
- carisoprodol
- Active ingredients
- Carisoprodol — 350 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040188
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 72789-190_2d6a0cc6-8c41-6b0a-e063-6394a90a0c11SPL ID 2d6a0cc6-8c41-6b0a-e063-6394a90a0c11SPL set ID 9d251c26-c893-425a-b8ac-20c06e50e80cRxCUI 197446UNII 21925K482HUPC 0372789190303
- 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
N472789019014followed by a unit qualifier and the quantityPackage 72789-0190-14. 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 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) ]. Carisoprodol 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 ANDA 040188
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 | A-S Medication Solutions | 50090-5955 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Medsource Pharmaceuticals | 45865-233 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | A-S Medication Solutions | 50090-5953 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-111 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1928 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9621 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-617 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Proficient Rx LP | 71205-704 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2416 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-182 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Directrx | 72189-310 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2800 |
| Carisoprodol | Carisoprodol 350 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-761 |