NDC codes

FDA NDC Directory
Product NDC (as listed)43063-794Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0794Add 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
43063-794-30430630794304306307943030 TABLET in 1 BOTTLE, PLASTIC (43063-794-30)Marketed from Oct 10, 2017
43063-794-60430630794604306307946060 TABLET in 1 BOTTLE, PLASTIC (43063-794-60)Marketed from Oct 10, 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 — 1 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 43063-794_415b681a-3c14-e26d-e063-6394a90a2fcbSPL ID 415b681a-3c14-e26d-e063-6394a90a2fcbSPL set ID 9ee4e019-6a99-4aac-84b0-9aae597815a7RxCUI 197528UNII 5PE9FDE8GBUPC 0343063794302
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

N443063079430 followed by a unit qualifier and the quantity

Package 43063-0794-30. 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.

Full label on DailyMed (opens in a new tab)

About NDC 43063-794

What is NDC 43063-794?
43063-794 is the product NDC for Clonazepam, Clonazepam 1 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. 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?
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.

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 .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
ClonazepamClonazepam 2 mg/1TabletOralBryant Ranch Prepack71335-0333

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