Prescription drug · NDA
Klonopin (Clonazepam) NDC 61269-605
Clonazepam .5 mg/1 · Tablet · Oral · H2-Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-605-10 | 6126906051061269060510 | 100 TABLET in 1 BOTTLE, PLASTIC (61269-605-10)Marketed from Aug 26, 2010 |
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)
- Klonopin
- Generic name (nonproprietary)
- clonazepam
- Active ingredients
- Clonazepam — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- H2-Pharma, LLCNDC labeler code 61269
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017533
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 61269-605_63cfdab9-fb3d-4c2b-bf88-8ba841dba839SPL ID 63cfdab9-fb3d-4c2b-bf88-8ba841dba839SPL set ID cfa0d79a-843c-4b88-95a1-e9511d649ca1RxCUI 197527, 197528, 197529, 206157, 206159, 206160UNII 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
N461269060510followed by a unit qualifier and the quantityPackage 61269-0605-10. 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 Klonopin 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, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). Panic Disorder Klonopin 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 implications or con…
Excerpt only. Read the full label for complete information.
About NDC 61269-605
- What is NDC 61269-605?
- 61269-605 is the product NDC for Klonopin (clonazepam), Clonazepam .5 mg/1 tablet, listed with the FDA by H2-Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Klonopin (Clonazepam).
- What is the active ingredient?
- Clonazepam.
- Who is the labeler?
- H2-Pharma, LLC, NDC labeler code 61269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Klonopin?
- 2 other product NDCs are listed under this name. See all Klonopin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Klonopin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Klonopinclonazepam | Clonazepam 1 mg/1 | TabletOral | H2-Pharma, LLC | 61269-610 | 61269-0610-10 |
| Klonopinclonazepam | Clonazepam 2 mg/1 | TabletOral | H2-Pharma, LLC | 61269-620 | 61269-0620-10 |
Other NDCs under NDA 017533
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 |
|---|---|---|---|---|
| Klonopinclonazepam | Clonazepam 1 mg/1 | TabletOral | H2-Pharma, LLC | 61269-610 |
| Klonopinclonazepam | Clonazepam 2 mg/1 | TabletOral | H2-Pharma, LLC | 61269-620 |