Prescription drug · ANDA
Clonazepam NDC 43547-408
Clonazepam 2 mg/1 · Tablet · Oral · Solco Healthcare LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-408-10 | 43547040810 | 100 TABLET in 1 BOTTLE, PLASTIC (43547-408-10)Marketed from Feb 15, 2018 | |
| 43547-408-50 | 43547040850 | 500 TABLET in 1 BOTTLE, PLASTIC (43547-408-50)Marketed from Feb 15, 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)
- Clonazepam
- Generic name (nonproprietary)
- clonazepam
- Active ingredients
- Clonazepam — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077856
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 43547-408_dc17b9d4-2890-4f6c-8476-daa39d0cbc9cSPL ID dc17b9d4-2890-4f6c-8476-daa39d0cbc9cSPL set ID 4acbb7a9-4db5-4497-b8db-9f358b3f6fb4RxCUI 197527, 197528, 197529UNII 5PE9FDE8GBUPC 0343547408107, 0343547406103, 0343547407100
- 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
N443547040810followed by a unit qualifier and the quantityPackage 43547-0408-10. 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 is 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 may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). Panic Disorder: Clonazepam is 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, worry about the implication…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077856
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 | Bryant Ranch Prepack | 63629-1116 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | American Health Packaging | 60687-872 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | DIRECT RX | 72189-081 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-771 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1364 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1366 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8499 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3613 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1810 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | American Health Packaging | 60687-861 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-307 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-817 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1843 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1856 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8988 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Direct_Rx | 72189-475 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4318 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4319 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1203 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1201 |
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