Prescription drug · ANDA
Clobazam NDC 67877-658
Clobazam 2.5 mg/mL · Suspension · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-658-61 | 6787706586167877065861 | 1 BOTTLE in 1 CARTON (67877-658-61) / 120 mL in 1 BOTTLEMarketed from May 7, 2021 |
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
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213039
- 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 67877-658_1555689f-8f9a-4042-8a94-911e90904dd0SPL ID 1555689f-8f9a-4042-8a94-911e90904dd0SPL set ID 07e0ae51-cc71-427f-83cb-311b7fcc5993RxCUI 1366192UNII 2MRO291B4UUPC 0367877658612
- 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
N467877065861followed by a unit qualifier and the quantityPackage 67877-0658-61. 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 67877-658
- What is NDC 67877-658?
- 67877-658 is the product NDC for Clobazam, Clobazam 2.5 mg/mL suspension, listed with the FDA by Ascend Laboratories, LLC. 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 2.5 mg/mL | SuspensionOral | Precision Dose, Inc. | 68094-074 | 68094-0074-58 |
| 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 | 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 |