NDC codes

FDA NDC Directory
Product NDC (as listed)43547-408Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0408Add 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
43547-408-104354704081043547040810100 TABLET in 1 BOTTLE, PLASTIC (43547-408-10)Marketed from Feb 15, 2018
43547-408-504354704085043547040850500 TABLET in 1 BOTTLE, PLASTIC (43547-408-50)Marketed from Feb 15, 2018

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
Solco Healthcare LLCNDC labeler code 43547
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077856
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 43547-408_dc17b9d4-2890-4f6c-8476-daa39d0cbc9cSPL ID dc17b9d4-2890-4f6c-8476-daa39d0cbc9cSPL set ID 4acbb7a9-4db5-4497-b8db-9f358b3f6fb4RxCUI 197527, 197528, 197529UNII 5PE9FDE8GBUPC 0343547408107, 0343547406103, 0343547407100
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

N443547040810 followed by a unit qualifier and the quantity

Package 43547-0408-10. 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 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 attacks, worry about the implication…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43547-408

What is NDC 43547-408?
43547-408 is the product NDC for Clonazepam, Clonazepam 2 mg/1 tablet, listed with the FDA by Solco Healthcare LLC. It has 2 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?
Solco Healthcare LLC, NDC labeler code 43547. 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 077856

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

FDA NDC Directory listings under ANDA 077856
ProductStrengthForm · routeLabelerProduct NDC
ClonazepamClonazepam .5 mg/1TabletOralMajor Pharmaceuticals0904-7227
ClonazepamClonazepam 1 mg/1TabletOralMajor Pharmaceuticals0904-7728
ClonazepamClonazepam .5 mg/1TabletOralSolco Healthcare LLC43547-406
ClonazepamClonazepam 1 mg/1TabletOralSolco Healthcare LLC43547-407
ClonazepamClonazepam .5 mg/1TabletOralAvPAK50268-173
ClonazepamClonazepam 1 mg/1TabletOralAvPAK50268-174
ClonazepamClonazepam 2 mg/1TabletOralAvPAK50268-175
ClonazepamClonazepam .5 mg/1TabletOralCardinal Health 107, LLC55154-4318
ClonazepamClonazepam 1 mg/1TabletOralCardinal Health 107, LLC55154-4319
ClonazepamClonazepam .5 mg/1TabletOralAmerican Health Packaging60687-861
ClonazepamClonazepam 1 mg/1TabletOralAmerican Health Packaging60687-872
ClonazepamClonazepam 1 mg/1TabletOralBryant Ranch Prepack63629-1116
ClonazepamClonazepam .5 mg/1TabletOralBryant Ranch Prepack63629-1201
ClonazepamClonazepam .5 mg/1TabletOralBryant Ranch Prepack63629-1202
ClonazepamClonazepam .5 mg/1TabletOralBryant Ranch Prepack63629-1203
ClonazepamClonazepam 1 mg/1TabletOralBryant Ranch Prepack63629-1205
ClonazepamClonazepam 2 mg/1TabletOralBryant Ranch Prepack63629-1206
ClonazepamClonazepam 2 mg/1TabletOralBryant Ranch Prepack63629-1207
ClonazepamClonazepam 1 mg/1TabletOralBryant Ranch Prepack63629-8988
ClonazepamClonazepam 1 mg/1TabletOralCoupler LLC67046-0794

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