Prescription drug · ANDA
Clonazepam NDC 50268-173
Clonazepam .5 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-173-15 | 50268017315 | 50 BLISTER PACK in 1 BOX (50268-173-15) / 1 TABLET in 1 BLISTER PACK (50268-173-11)Marketed from Jan 16, 2023 |
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
- AvPAK
- 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 50268-173_4b984e6f-72aa-4fdc-e063-6394a90af105SPL ID 4b984e6f-72aa-4fdc-e063-6394a90af105SPL set ID f2662808-01c4-330c-e053-2a95a90aa335RxCUI 197527, 197528, 197529UNII 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
N450268017315followed by a unit qualifier and the quantityPackage 50268-0173-15. 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 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. 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 re-establish efficacy. 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 as…
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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