Prescription drug · ANDA
Clonazepam NDC 67544-529
Clonazepam .5 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67544-529-10 | 67544052910 | 10 TABLET in 1 BOTTLE (67544-529-10)Marketed from Jul 14, 2023 | |
| 67544-529-15 | 67544052915 | 15 TABLET in 1 BOTTLE (67544-529-15)Marketed from Mar 6, 2018 | |
| 67544-529-28 | 67544052928 | 28 TABLET in 1 BOTTLE (67544-529-28)Marketed from Jul 14, 2023 | |
| 67544-529-30 | 67544052930 | 30 TABLET in 1 BOTTLE (67544-529-30)Marketed from Mar 6, 2018 | |
| 67544-529-45 | 67544052945 | 45 TABLET in 1 BOTTLE (67544-529-45)Marketed from Mar 6, 2018 | |
| 67544-529-53 | 67544052953 | 60 TABLET in 1 BOTTLE (67544-529-53)Marketed from Mar 6, 2018 | |
| 67544-529-54 | 67544052954 | 84 TABLET in 1 BOTTLE (67544-529-54)Marketed from Jul 14, 2023 | |
| 67544-529-55 | 67544052955 | 75 TABLET in 1 BOTTLE (67544-529-55)Marketed from Jul 14, 2023 | |
| 67544-529-60 | 67544052960 | 90 TABLET in 1 BOTTLE (67544-529-60)Marketed from Mar 6, 2018 | |
| 67544-529-70 | 67544052970 | 120 TABLET in 1 BOTTLE (67544-529-70)Marketed from Mar 6, 2018 | |
| 67544-529-75 | 67544052975 | 150 TABLET in 1 BOTTLE (67544-529-75)Marketed from Mar 6, 2018 | |
| 67544-529-80 | 67544052980 | 180 TABLET in 1 BOTTLE (67544-529-80)Marketed from Mar 6, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074569
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 67544-529_2458678c-6ce9-4fa4-976a-2c49b489a834SPL ID 2458678c-6ce9-4fa4-976a-2c49b489a834SPL set ID 6be64dc3-3748-477c-8800-2c2175309c73RxCUI 197527UNII 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
N467544052910followed by a unit qualifier and the quantityPackage 67544-0529-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 074569
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 | Proficient Rx LP | 63187-226 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Coupler LLC | 67046-0493 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-4841 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2507 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-0832 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3144 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3212 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-0832 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3213 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-749 |