Prescription drug · ANDA
Clonazepam NDC 63187-603
Clonazepam .5 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-603-30 | 6318706033063187060330 | 30 TABLET in 1 BOTTLE, PLASTIC (63187-603-30)Marketed from Dec 1, 2018 | |
| 63187-603-60 | 6318706036063187060360 | 60 TABLET in 1 BOTTLE, PLASTIC (63187-603-60)Marketed from Dec 1, 2018 | |
| 63187-603-90 | 6318706039063187060390 | 90 TABLET in 1 BOTTLE, PLASTIC (63187-603-90)Marketed from Dec 1, 2018 |
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
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077147
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 63187-603_0bfb873c-326d-4383-8a64-c6ffe16f0fbeSPL ID 0bfb873c-326d-4383-8a64-c6ffe16f0fbeSPL set ID 4dcb6785-e16b-4692-89b3-f905979ca5aeRxCUI 197527UNII 5PE9FDE8GBUPC 0363187603304
- 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
N463187060330followed by a unit qualifier and the quantityPackage 63187-0603-30. 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 reestablish efficacy. Panic Disorder: Clonazepam is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and as…
Excerpt only. Read the full label for complete information.
About NDC 63187-603
- What is NDC 63187-603?
- 63187-603 is the product NDC for Clonazepam, Clonazepam .5 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clonazepam.
- What is the active ingredient?
- Clonazepam.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clonazepam?
- 141 other product NDCs are listed under this name. See all Clonazepam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clonazepam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8781 | 68788-8781-0268788-8781-0368788-8781-06+1 more |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-090 | 87441-0090-01 |
| Clonazepam | Clonazepam .25 mg/1 | TabletOral | TruPharma LLC | 52817-305 | 52817-0305-90 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Coupler LLC | 67046-0493 | 67046-0493-03 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-021 | 87441-0021-01 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-022 | 87441-0022-01 |
| Clonazepam | Clonazepam .25 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-497 | 72888-0497-0172888-0497-0272888-0497-03+1 more |
| clonazepam | Clonazepam 1 mg/1 | Tablet, Orally disintegratingOral | Advagen Pharma Ltd | 72888-136 | 72888-0136-2972888-0136-31 |
| clonazepam | Clonazepam .125 mg/1 | Tablet, Orally disintegratingOral | Advagen Pharma Ltd | 72888-133 | 72888-0133-2972888-0133-31 |
| clonazepam | Clonazepam .25 mg/1 | Tablet, Orally disintegratingOral | Advagen Pharma Ltd | 72888-134 | 72888-0134-2972888-0134-31 |
Other NDCs under ANDA 077147
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 | TabletOral | Accord Healthcare Inc. | 16729-136 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-137 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-138 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-788 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-794 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-797 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-2022 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-2088 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | St Marys Medical Park Pharmacy | 60760-300 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Proficient Rx LP | 63187-888 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4021 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5247 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1297 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1521 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1801 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2232 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2334 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0022 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0113 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0333 |
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