Prescription drug · ANDA
Carisoprodol Tablets, USP, 350 mg NDC 63561-0127
carisoprodol · Carisoprodol 350 mg/1 · Tablet · Oral · Granulation Technology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63561-0127-1 | 63561012701 | 100 TABLET in 1 BOTTLE, PLASTIC (63561-0127-1)Marketed from Jun 11, 2025 | |
| 63561-0127-2 | 63561012702 | 1000 TABLET in 1 BOTTLE, PLASTIC (63561-0127-2)Marketed from Jun 11, 2025 |
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 Tablets, USP, 350 mg
- Generic name (nonproprietary)
- carisoprodol
- Active ingredients
- Carisoprodol — 350 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Granulation Technology, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211789
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 63561-0127_37394c09-4ae3-400c-e063-6294a90a65d2SPL ID 37394c09-4ae3-400c-e063-6294a90a65d2SPL set ID 2abd11e4-8ce4-4aeb-87c4-3af94c197714RxCUI 197446UNII 21925K482HUPC 0363561012722
- 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
N463561012701followed by a unit qualifier and the quantityPackage 63561-0127-01. 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)
Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol Tablets, USP 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 Tablet 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 thr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211789
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 Tablets, USP, 350 mgcarisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2525 |
| Carisoprodol Tablets, USP, 350 mgcarisoprodol | Carisoprodol 350 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3018 |
| Carisoprodol Tablets, USP, 350 mgcarisoprodol | Carisoprodol 350 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-477 |