Prescription drug · ANDA
Clonazepam NDC 68071-3613
Clonazepam 2 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3613-6 | 68071361306 | 60 TABLET in 1 BOTTLE, PLASTIC (68071-3613-6)Marketed from May 30, 2024 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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 68071-3613_19b1f515-5241-e6b9-e063-6394a90a7c2cSPL ID 19b1f515-5241-e6b9-e063-6394a90a7c2cSPL set ID 19b1fe7b-8f7b-03b7-e063-6394a90a9ba5RxCUI 197529UNII 5PE9FDE8GBUPC 0368071361360
- 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
N468071361306followed by a unit qualifier and the quantityPackage 68071-3613-06. 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 .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 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1202 |
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