NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0135Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0135Add 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 NDC11-digit (billing)PackageCopy
80425-0135-1804250135018042501350130 TABLET in 1 BOTTLE (80425-0135-1)Marketed from Jun 3, 2011
80425-0135-2804250135028042501350260 TABLET in 1 BOTTLE (80425-0135-2)Marketed from Jun 3, 2011
80425-0135-3804250135038042501350390 TABLET in 1 BOTTLE (80425-0135-3)Marketed from Jun 3, 2011

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 — 1 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 077147
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 80425-0135_2a99b834-0c98-6f97-e063-6394a90a8407SPL ID 2a99b834-0c98-6f97-e063-6394a90a8407SPL set ID be383e56-d71f-7699-e053-2995a90a50c1RxCUI 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

N480425013501 followed by a unit qualifier and the quantity

Package 80425-0135-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Indications and Usage Section INDICATIONS AND USAGE Seizure Disorders: Clonazepam is 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 may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS : Loss of Effect). Panic Disorder: Clonazepam is 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 attack…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0135

What is NDC 80425-0135?
80425-0135 is the product NDC for Clonazepam, Clonazepam 1 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ClonazepamClonazepam 2 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-878168788-8781-0268788-8781-0368788-8781-06+1 more
ClonazepamClonazepam .5 mg/1TabletOralUnit Dose Solutions, Inc.87441-09087441-0090-01
ClonazepamClonazepam .25 mg/1TabletOralTruPharma LLC52817-30552817-0305-90
ClonazepamClonazepam 1 mg/1TabletOralCoupler LLC67046-049367046-0493-03
ClonazepamClonazepam .5 mg/1TabletOralUnit Dose Solutions, Inc.87441-02187441-0021-01
ClonazepamClonazepam 1 mg/1TabletOralUnit Dose Solutions, Inc.87441-02287441-0022-01
ClonazepamClonazepam .25 mg/1TabletOralAdvagen Pharma Ltd72888-49772888-0497-0172888-0497-0272888-0497-03+1 more
clonazepamClonazepam 1 mg/1Tablet, Orally disintegratingOralAdvagen Pharma Ltd72888-13672888-0136-2972888-0136-31
clonazepamClonazepam .125 mg/1Tablet, Orally disintegratingOralAdvagen Pharma Ltd72888-13372888-0133-2972888-0133-31
clonazepamClonazepam .25 mg/1Tablet, Orally disintegratingOralAdvagen Pharma Ltd72888-13472888-0134-2972888-0134-31

All 142 Clonazepam NDCs

Other NDCs under ANDA 077147

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

FDA NDC Directory listings under ANDA 077147
ProductStrengthForm · routeLabelerProduct NDC
ClonazepamClonazepam .5 mg/1TabletOralAccord Healthcare Inc.16729-136
ClonazepamClonazepam 1 mg/1TabletOralAccord Healthcare Inc.16729-137
ClonazepamClonazepam 2 mg/1TabletOralAccord Healthcare Inc.16729-138
ClonazepamClonazepam 2 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-788
ClonazepamClonazepam 1 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-794
ClonazepamClonazepam .5 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-797
ClonazepamClonazepam 1 mg/1TabletOralA-S Medication Solutions50090-2022
ClonazepamClonazepam .5 mg/1TabletOralA-S Medication Solutions50090-2088
ClonazepamClonazepam 1 mg/1TabletOralSt Marys Medical Park Pharmacy60760-300
ClonazepamClonazepam .5 mg/1TabletOralProficient Rx LP63187-603
ClonazepamClonazepam 1 mg/1TabletOralProficient Rx LP63187-888
ClonazepamClonazepam .5 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4021
ClonazepamClonazepam 1 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5247
ClonazepamClonazepam .5 mg/1TabletOralREMEDYREPACK INC.70518-1297
ClonazepamClonazepam 1 mg/1TabletOralREMEDYREPACK INC.70518-1521
ClonazepamClonazepam .5 mg/1TabletOralREMEDYREPACK INC.70518-1801
ClonazepamClonazepam 2 mg/1TabletOralREMEDYREPACK INC.70518-2232
ClonazepamClonazepam 1 mg/1TabletOralREMEDYREPACK INC.70518-2334
ClonazepamClonazepam 1 mg/1TabletOralBryant Ranch Prepack71335-0022
ClonazepamClonazepam .5 mg/1TabletOralBryant Ranch Prepack71335-0113

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