What is NDC 80425-0402?

80425-0402 is the product NDC for Clonazepam, Clonazepam .5 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clonazepam NDC 80425-0402 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0402Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0402Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
80425-0402-1	8042504020180425040201	30 TABLET in 1 BOTTLE (80425-0402-1)Marketed from Jun 7, 2024
80425-0402-2	8042504020280425040202	60 TABLET in 1 BOTTLE (80425-0402-2)Marketed from Jun 7, 2024
80425-0402-3	8042504020380425040203	90 TABLET in 1 BOTTLE (80425-0402-3)Marketed from Jun 7, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075150
Marketing start: Sep 8, 2023
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 80425-0402_1a50d75c-4b78-d4d0-e063-6394a90a1298SPL ID 1a50d75c-4b78-d4d0-e063-6394a90a1298SPL set ID 04db0fbe-7fa3-28af-e063-6294a90abbe6RxCUI 197527, 197528UNII 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

N480425040201 followed by a unit qualifier and the quantity

Package 80425-0402-01. 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 Jun 7, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0402

What is NDC 80425-0402?: 80425-0402 is the product NDC for Clonazepam, Clonazepam .5 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. 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?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Clonazepam NDCs
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

All 142 Clonazepam NDCs

Other NDCs under ANDA 075150

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075150
Product	Strength	Form · route	Labeler	Product NDC
Clonazepam	Clonazepam .5 mg/1	TabletOral	Aurobindo Pharma Limited	59651-722
Clonazepam	Clonazepam 1 mg/1	TabletOral	Aurobindo Pharma Limited	59651-723
Clonazepam	Clonazepam 2 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8781
Clonazepam	Clonazepam 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-3849
Clonazepam	Clonazepam .5 mg/1	TabletOral	REMEDYREPACK INC.	70518-3960
Clonazepam	Clonazepam 1 mg/1	TabletOral	REMEDYREPACK INC.	70518-4074
Clonazepam	Clonazepam 2 mg/1	TabletOral	Bryant Ranch Prepack	71335-2653
Clonazepam	Clonazepam 1 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-852
Clonazepam	Clonazepam .5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-855
Clonazepam	Clonazepam 1 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0357
Clonazepam	Clonazepam 1 mg/1	TabletOral	Proficient Rx LP	82804-272