Prescription drug · ANDA
Clonazepam NDC 43063-788
Clonazepam 2 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-788-30 | 4306307883043063078830 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-788-30)Marketed from Sep 1, 2017 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- 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 43063-788_414bb263-b84a-5358-e063-6294a90ad4bcSPL ID 414bb263-b84a-5358-e063-6294a90ad4bcSPL set ID 1ce88d2c-70f7-427b-8787-4afd9ce6f71cRxCUI 197529UNII 5PE9FDE8GBUPC 0343063788301
- 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
N443063078830followed by a unit qualifier and the quantityPackage 43063-0788-30. 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 . 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, …
Excerpt only. Read the full label for complete information.
About NDC 43063-788
- What is NDC 43063-788?
- 43063-788 is the product NDC for Clonazepam, Clonazepam 2 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 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 .5 mg/1 | TabletOral | Proficient Rx LP | 63187-603 |
| 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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