Prescription drug · ANDA
Clonazepam NDC 71610-790
Clonazepam .5 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-790-10 | 7161007901071610079010 | 10 TABLET in 1 BOTTLE (71610-790-10)Marketed from Oct 23, 2024 | |
| 71610-790-15 | 7161007901571610079015 | 15 TABLET in 1 BOTTLE (71610-790-15)Marketed from Jan 25, 2024 | |
| 71610-790-20 | 7161007902071610079020 | 20 TABLET in 1 BOTTLE (71610-790-20)Marketed from Feb 5, 2024 | |
| 71610-790-28 | 7161007902871610079028 | 28 TABLET in 1 BOTTLE (71610-790-28)Marketed from Jan 25, 2024 | |
| 71610-790-30 | 7161007903071610079030 | 30 TABLET in 1 BOTTLE (71610-790-30)Marketed from Oct 23, 2024 | |
| 71610-790-45 | 7161007904571610079045 | 45 TABLET in 1 BOTTLE (71610-790-45)Marketed from Oct 23, 2024 | |
| 71610-790-46 | 7161007904671610079046 | 56 TABLET in 1 BOTTLE (71610-790-46)Marketed from Oct 23, 2024 | |
| 71610-790-53 | 7161007905371610079053 | 60 TABLET in 1 BOTTLE (71610-790-53)Marketed from Oct 23, 2024 | |
| 71610-790-55 | 7161007905571610079055 | 75 TABLET in 1 BOTTLE (71610-790-55)Marketed from Jan 25, 2024 | |
| 71610-790-60 | 7161007906071610079060 | 90 TABLET in 1 BOTTLE (71610-790-60)Marketed from Jan 25, 2024 | |
| 71610-790-70 | 7161007907071610079070 | 120 TABLET in 1 BOTTLE (71610-790-70)Marketed from Jan 25, 2024 |
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
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075468
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 71610-790_2528d6db-eb77-3ccc-e063-6294a90a3022SPL ID 2528d6db-eb77-3ccc-e063-6294a90a3022SPL set ID 8891c5aa-f42a-4206-92b9-f0ed0631dfcbRxCUI 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
N471610079010followed by a unit qualifier and the quantityPackage 71610-0790-10. 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: Clonazepam tablets are 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 tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). Panic Disorder: Clonazepam tablets are 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, w…
Excerpt only. Read the full label for complete information.
About NDC 71610-790
- What is NDC 71610-790?
- 71610-790 is the product NDC for Clonazepam, Clonazepam .5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 11 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 075468
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 .25 mg/1 | TabletOral | TruPharma LLC | 52817-305 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-0152 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-0153 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-0154 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Coupler LLC | 67046-1488 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Coupler LLC | 67046-1521 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8473 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3891 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2414 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2509 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9747 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Northstar Rx LLC | 72603-307 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Northstar Rx LLC | 72603-308 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Northstar Rx LLC | 72603-309 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-152 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-153 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-154 |
| Clonazepam | Clonazepam .25 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-497 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-021 |
| Clonazepam | Clonazepam 1 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-022 |