Prescription drug · ANDA
Clobazam NDC 51407-586
Clobazam 20 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-586-01 | 51407058601 | 100 TABLET in 1 BOTTLE (51407-586-01)Marketed from Jul 30, 2024 |
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)
- Clobazam
- Generic name (nonproprietary)
- clobazam
- Active ingredients
- Clobazam — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209687
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)
- Identifiers
- Product ID 51407-586_30dccf40-ebb5-8bfd-e063-6394a90adeabSPL ID 30dccf40-ebb5-8bfd-e063-6394a90adeabSPL set ID 2166ea46-28ff-f492-e063-6394a90a4a45RxCUI 199450, 246172UNII 2MRO291B4U
- Pharmacologic class
- Benzodiazepine
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
N451407058601followed by a unit qualifier and the quantityPackage 51407-0586-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Clobazam tablets are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam tablets are a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209687
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 |
|---|---|---|---|---|
| Clobazam | Clobazam 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-585 |
| Clobazam | Clobazam 10 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-0580 |
| Clobazam | Clobazam 20 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-0581 |