Prescription drug · ANDA
Clonazepam NDC 63187-226
Clonazepam .5 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-226-30 | 63187022630 | 30 TABLET in 1 BOTTLE (63187-226-30)Marketed from Sep 1, 2014 | |
| 63187-226-60 | 63187022660 | 60 TABLET in 1 BOTTLE (63187-226-60)Marketed from Sep 1, 2014 | |
| 63187-226-90 | 63187022690 | 90 TABLET in 1 BOTTLE (63187-226-90)Marketed from Sep 1, 2014 |
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)
- Clonazepam
- Generic name (nonproprietary)
- clonazepam
- Active ingredients
- Clonazepam — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 63187-226_fe8abfbc-e750-4c0b-ae2d-a66355c86624SPL ID fe8abfbc-e750-4c0b-ae2d-a66355c86624SPL set ID 56175c25-3fde-43ea-89bf-22dcf3278b6bRxCUI 197527UNII 5PE9FDE8GBUPC 0363187226305
- 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
N463187022630followed by a unit qualifier and the quantityPackage 63187-0226-30. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Seizure Disorders Clonazepam tablets USP 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 USP may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder Clonazepam tablts USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence…
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 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 .5 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-0832 |
| 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 |