Prescription drug · ANDA
Clonazepam NDC 58118-0832
Clonazepam .5 mg/1 · Tablet · Oral · Clinical Solutions Wholesale, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58118-0832-8 | 58118083208 | 30 TABLET in 1 BLISTER PACK (58118-0832-8)Marketed from Mar 26, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Clonazepam
- Generic name (nonproprietary)
- clonazepam
- Active ingredients
- Clonazepam — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074569
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 58118-0832_0e852f9b-ed29-bc08-e063-6394a90a28dbSPL ID 0e852f9b-ed29-bc08-e063-6394a90a28dbSPL set ID 429a15d1-1675-42cc-97f1-c49b03747416RxCUI 197527UNII 5PE9FDE8GB
- 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
N458118083208followed by a unit qualifier and the quantityPackage 58118-0832-08. 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)
INDICATIONS AND USAGE Seizure Disorders Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). Panic Disorder Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, wor…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074569
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 |
|---|---|---|---|---|
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Proficient Rx LP | 63187-226 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Coupler LLC | 67046-0493 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-4841 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2507 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3144 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-529 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3212 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-0832 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3213 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-749 |