Prescription drug · ANDA
Clobazam NDC 68094-074
Clobazam 2.5 mg/mL · Suspension · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-074-58 | 6809400745868094007458 | 50 BAG in 1 CASE (68094-074-58) / 1 SYRINGE, PLASTIC in 1 BAG (68094-074-01) / 4 mL in 1 SYRINGE, PLASTICMarketed from Mar 10, 2025 |
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 — 2.5 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Precision Dose, Inc.NDC labeler code 68094
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210039
- 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 68094-074_53326439-6544-44fa-b13c-6ea7517f4187SPL ID 53326439-6544-44fa-b13c-6ea7517f4187SPL set ID 6332e71c-3b37-422c-838c-8a2489ac6009RxCUI 1366192UNII 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
N468094007458followed by a unit qualifier and the quantityPackage 68094-0074-58. 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 oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam oral suspension 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 68094-074
- What is NDC 68094-074?
- 68094-074 is the product NDC for Clobazam, Clobazam 2.5 mg/mL suspension, listed with the FDA by Precision Dose, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clobazam.
- What is the active ingredient?
- Clobazam.
- Who is the labeler?
- Precision Dose, Inc., NDC labeler code 68094. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clobazam?
- 29 other product NDCs are listed under this name. See all Clobazam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clobazam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clobazam | Clobazam 5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-664 | 67877-0664-0167877-0664-0567877-0664-33 |
| Clobazam | Clobazam 10 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-047 | 72205-0047-91 |
| Clobazam | Clobazam 20 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-048 | 72205-0048-91 |
| Clobazam | Clobazam 2.5 mg/mL | SuspensionOral | Aurobindo Pharma Limited | 59651-401 | 59651-0401-12 |
| Clobazam | Clobazam 2.5 mg/mL | SuspensionOral | Bryant Ranch Prepack | 72162-2608 | 72162-2608-02 |
| Clobazam | Clobazam 2.5 mg/mL | SuspensionOral | Sun Pharmaceutical Industries, Inc. | 51672-4227 | 51672-4227-08 |
| Clobazam | Clobazam 2.5 mg/mL | SuspensionOral | Ascend Laboratories, LLC | 67877-658 | 67877-0658-61 |
| Clobazam | Clobazam 2.5 mg/mL | SuspensionOral | NorthStar RxLLC | 16714-087 | 16714-0087-01 |
| Clobazam | Clobazam 2.5 mg/mL | SuspensionOral | Chartwell RX, LLC | 62135-527 | 62135-0527-41 |
| Clobazam | Clobazam 2.5 mg/mL | SuspensionOral | Camber Pharmaceuticals, Inc. | 31722-641 | 31722-0641-12 |
Other NDCs under ANDA 210039
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 2.5 mg/mL | SuspensionOral | Amneal Pharmaceuticals NY LLC | 69238-1535 |