Prescription drug · ANDA
Clobazam NDC 31722-640
Clobazam 20 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-640-01 | 31722064001 | 100 TABLET in 1 BOTTLE (31722-640-01)Marketed from Oct 22, 2018 | |
| 31722-640-31 | 31722064031 | 10 BLISTER PACK in 1 CARTON (31722-640-31) / 10 TABLET in 1 BLISTER PACKMarketed from Oct 22, 2018 |
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
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209795
- 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 31722-640_22eea187-7659-07de-e063-6394a90a5dcaSPL ID 22eea187-7659-07de-e063-6394a90a5dcaSPL set ID cf31b8d1-0d19-4529-99b6-1f7366064a3cRxCUI 199450, 246172UNII 2MRO291B4UUPC 0331722640015, 0331722639019
- 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
N431722064001followed by a unit qualifier and the quantityPackage 31722-0640-01. 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 tablet is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam is 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 209795
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.