Prescription drug · NDA
Sympazan (Clobazam) NDC 10094-205
Clobazam 5 mg/1 · Film · Oral · Aquestive Therapeutics
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10094-205-60 | 1009402056010094020560 | 60 POUCH in 1 PACKAGE (10094-205-60) / 1 FILM in 1 POUCH (10094-205-01)Marketed from Nov 1, 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)
- Sympazan
- Generic name (nonproprietary)
- clobazam
- Active ingredients
- Clobazam — 5 mg/1
- Dosage form
- Film
- Route
- Oral
- Labeler
- Aquestive TherapeuticsNDC labeler code 10094
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210833
- 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 10094-205_4a004ed9-140a-4054-843c-4e31d42667ecSPL ID 4a004ed9-140a-4054-843c-4e31d42667ecSPL set ID 5e3d8fcb-aa7d-4822-88fc-4f06264c3242RxCUI 2058253, 2058254, 2058255, 2102713, 2102715, 2102717UNII 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
N410094020560followed by a unit qualifier and the quantityPackage 10094-0205-60. 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)
SYMPAZAN ® is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older. SYMPAZAN ® 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.
About NDC 10094-205
- What is NDC 10094-205?
- 10094-205 is the product NDC for Sympazan (clobazam), Clobazam 5 mg/1 film, listed with the FDA by Aquestive Therapeutics. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sympazan (Clobazam).
- What is the active ingredient?
- Clobazam.
- Who is the labeler?
- Aquestive Therapeutics, NDC labeler code 10094. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sympazan?
- 2 other product NDCs are listed under this name. See all Sympazan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sympazan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sympazanclobazam | Clobazam 10 mg/1 | FilmOral | Aquestive Therapeutics | 10094-210 | 10094-0210-60 |
| Sympazanclobazam | Clobazam 20 mg/1 | FilmOral | Aquestive Therapeutics | 10094-220 | 10094-0220-60 |
Other NDCs under NDA 210833
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 |
|---|---|---|---|---|
| Sympazanclobazam | Clobazam 10 mg/1 | FilmOral | Aquestive Therapeutics | 10094-210 |
| Sympazanclobazam | Clobazam 20 mg/1 | FilmOral | Aquestive Therapeutics | 10094-220 |