What is NDC 68788-8401?

68788-8401 is the product NDC for Clonazepam, Clonazepam 1 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?

140 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 68788-8401 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8401Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8401Add 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
68788-8401-2	68788840102	20 TABLET in 1 BOTTLE, PLASTIC (68788-8401-2)Marketed from Mar 21, 2023
68788-8401-3	68788840103	30 TABLET in 1 BOTTLE, PLASTIC (68788-8401-3)Marketed from Mar 21, 2023
68788-8401-6	68788840106	60 TABLET in 1 BOTTLE, PLASTIC (68788-8401-6)Marketed from Mar 21, 2023
68788-8401-8	68788840108	28 TABLET in 1 BOTTLE, PLASTIC (68788-8401-8)Marketed from Mar 21, 2023
68788-8401-9	68788840109	90 TABLET in 1 BOTTLE, PLASTIC (68788-8401-9)Marketed from Mar 21, 2023

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: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077856
Marketing start: Mar 21, 2023
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 68788-8401_f9ccda6a-4c5a-4acf-8a78-cb854f4f14e5SPL ID f9ccda6a-4c5a-4acf-8a78-cb854f4f14e5SPL set ID 87f362a7-cf66-4166-af51-ac2da473cf6bRxCUI 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

N468788840102 followed by a unit qualifier and the quantity

Package 68788-8401-02. 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 Mar 31, 2026. 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 68788-8401

What is NDC 68788-8401?: 68788-8401 is the product NDC for Clonazepam, Clonazepam 1 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 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?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?: 140 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 .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 .5 mg/1	Tablet, Orally disintegratingOral	Advagen Pharma Ltd	72888-135	72888-0135-2972888-0135-31
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
clonazepam	Clonazepam 1 mg/1	Tablet, Orally disintegratingOral	Advagen Pharma Ltd	72888-136	72888-0136-2972888-0136-31

All 141 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
Product	Strength	Form · route	Labeler	Product NDC
Clonazepam	Clonazepam 1 mg/1	TabletOral	Solco Healthcare LLC	43547-407
Clonazepam	Clonazepam 2 mg/1	TabletOral	Solco Healthcare LLC	43547-408
Clonazepam	Clonazepam 1 mg/1	TabletOral	Proficient Rx LP	71205-529
Clonazepam	Clonazepam .5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-368
Clonazepam	Clonazepam .5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8420
Clonazepam	Clonazepam .5 mg/1	TabletOral	Solco Healthcare LLC	43547-406
Clonazepam	Clonazepam 1 mg/1	TabletOral	Major Pharmaceuticals	0904-7728
Clonazepam	Clonazepam .5 mg/1	TabletOral	Major Pharmaceuticals	0904-7227
Clonazepam	Clonazepam 1 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-771
Clonazepam	Clonazepam 2 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3613
Clonazepam	Clonazepam .5 mg/1	TabletOral	DIRECT RX	72189-081
Clonazepam	Clonazepam 2 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8499
Clonazepam	Clonazepam .5 mg/1	TabletOral	Bryant Ranch Prepack	72162-1364
Clonazepam	Clonazepam 2 mg/1	TabletOral	Bryant Ranch Prepack	72162-1366
Clonazepam	Clonazepam .5 mg/1	TabletOral	American Health Packaging	60687-861
Clonazepam	Clonazepam .5 mg/1	TabletOral	Bryant Ranch Prepack	71335-1810
Clonazepam	Clonazepam 1 mg/1	TabletOral	Bryant Ranch Prepack	63629-1116
Clonazepam	Clonazepam 1 mg/1	TabletOral	American Health Packaging	60687-872
Clonazepam	Clonazepam .5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-307
Clonazepam	Clonazepam 2 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-817

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