Prescription drug · ANDA
Clonazepam NDC 55154-4319
Clonazepam 1 mg/1 · Tablet · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-4319-0 | 55154431900 | 10 BLISTER PACK in 1 BAG (55154-4319-0) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 1, 2023 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cardinal Health 107, 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 55154-4319_b52bca59-8484-4549-b9c4-51222a783d92SPL ID b52bca59-8484-4549-b9c4-51222a783d92SPL set ID 5ad315f2-fa09-4956-b931-f9966fb73e4eRxCUI 197527, 197528UNII 5PE9FDE8GBUPC 0055154431804, 0055154431903
- 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
N455154431900followed by a unit qualifier and the quantityPackage 55154-4319-00. 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 .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1203 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1201 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1202 |
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