Prescription drug · ANDA
Clonazepam NDC 0093-9290
Clonazepam .125 mg/1 · Tablet, Orally disintegrating · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-9290-67 | 0009392906700093929067 | 60 BLISTER PACK in 1 CARTON (0093-9290-67) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Mar 2, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .125 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077194
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0093-9290_a2f2eb5b-f890-4d6d-b728-5f63eb7dc11cSPL ID a2f2eb5b-f890-4d6d-b728-5f63eb7dc11cSPL set ID cb2e209e-e69b-422b-8abb-34df2bc92caaRxCUI 349194, 349195, 349196, 349197, 349198UNII 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
N400093929067followed by a unit qualifier and the quantityPackage 00093-9290-67. 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 orally disintegrating 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 orally disintegrating tablets 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 orally disintegrating tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DS…
Excerpt only. Read the full label for complete information.
About NDC 0093-9290
- What is NDC 0093-9290?
- 0093-9290 is the product NDC for Clonazepam, Clonazepam .125 mg/1 tablet, orally disintegrating, listed with the FDA by Teva Pharmaceuticals USA, 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 1 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-022 | 87441-0022-01 |
| Clonazepam | Clonazepam .5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-021 | 87441-0021-01 |
| Clonazepam | Clonazepam .25 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-497 | 72888-0497-0172888-0497-0272888-0497-03+1 more |
| 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 |
| clonazepam | Clonazepam 2 mg/1 | Tablet, Orally disintegratingOral | Advagen Pharma Ltd | 72888-137 | 72888-0137-2972888-0137-31 |
Other NDCs under ANDA 077194
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 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-9291 |
| Clonazepam | Clonazepam .5 mg/1 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-9292 |
| Clonazepam | Clonazepam 1 mg/1 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-9293 |
| Clonazepam | Clonazepam 2 mg/1 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-9294 |