Prescription drug · ANDA
Clonazepam NDC 49884-307
Clonazepam .25 mg/1 · Tablet, Orally disintegrating · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-307-02 | 49884030702 | 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-307-02)Marketed from Aug 5, 2005 |
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 — .25 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077171
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 49884-307_cb847105-dbbe-4e7a-ab2b-ad0731638ce6SPL ID cb847105-dbbe-4e7a-ab2b-ad0731638ce6SPL set ID 1aef0069-80ea-483d-ac70-c8d485462c5bRxCUI 349194, 349195, 349196, 349197, 349198UNII 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
N449884030702followed by a unit qualifier and the quantityPackage 49884-0307-02. 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 orally disintegrating tablet 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 orally disintegrating tablets 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 orally disintegrating tablet is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077171
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 .5 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-308 |
| Clonazepam | Clonazepam .125 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-306 |
| Clonazepam | Clonazepam 1 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-309 |
| Clonazepam | Clonazepam 2 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-310 |