Prescription drug · ANDA
Clobazam NDC 67877-665
Clobazam 10 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-665-01 | 67877066501 | 100 CARTON in 1 CONTAINER (67877-665-01) / 1 TABLET in 1 CARTONMarketed from Sep 7, 2019 | |
| 67877-665-05 | 67877066505 | 500 TABLET in 1 CONTAINER (67877-665-05)Marketed from Sep 7, 2019 | |
| 67877-665-33 | 67877066533 | 10 CARTON in 1 BLISTER PACK (67877-665-33) / 1 TABLET in 1 CARTONMarketed from Sep 7, 2019 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212714
- 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 67877-665_f9dc8ac4-86be-49ab-9c2c-c60658f49d8fSPL ID f9dc8ac4-86be-49ab-9c2c-c60658f49d8fSPL set ID a77ffbdd-4e3e-4ec4-b0fa-b51ee610df0fRxCUI 199450, 246172, 427538UNII 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
N467877066501followed by a unit qualifier and the quantityPackage 67877-0665-01. 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 tablet 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 212714
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.