What is NDC 71610-368?

71610-368 is the product NDC for Clonazepam, Clonazepam .5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 16 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-368 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-368Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0368Add 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
71610-368-10	7161003681071610036810	10 TABLET in 1 BOTTLE, PLASTIC (71610-368-10)Marketed from Mar 26, 2020
71610-368-14	7161003681471610036814	14 TABLET in 1 BOTTLE, PLASTIC (71610-368-14)Marketed from Mar 26, 2020
71610-368-15	7161003681571610036815	15 TABLET in 1 BOTTLE, PLASTIC (71610-368-15)Marketed from Mar 12, 2020
71610-368-20	7161003682071610036820	20 TABLET in 1 BOTTLE, PLASTIC (71610-368-20)Marketed from Mar 26, 2020
71610-368-28	7161003682871610036828	28 TABLET in 1 BOTTLE, PLASTIC (71610-368-28)Marketed from Jan 29, 2020
71610-368-30	7161003683071610036830	30 TABLET in 1 BOTTLE, PLASTIC (71610-368-30)Marketed from Mar 12, 2020
71610-368-45	7161003684571610036845	45 TABLET in 1 BOTTLE, PLASTIC (71610-368-45)Marketed from Mar 12, 2020
71610-368-46	7161003684671610036846	56 TABLET in 1 BOTTLE, PLASTIC (71610-368-46)Marketed from Oct 14, 2024
71610-368-53	7161003685371610036853	60 TABLET in 1 BOTTLE, PLASTIC (71610-368-53)Marketed from Nov 20, 2019
71610-368-54	7161003685471610036854	84 TABLET in 1 BOTTLE, PLASTIC (71610-368-54)Marketed from Jan 29, 2020
71610-368-55	7161003685571610036855	75 TABLET in 1 BOTTLE, PLASTIC (71610-368-55)Marketed from May 8, 2020
71610-368-60	7161003686071610036860	90 TABLET in 1 BOTTLE, PLASTIC (71610-368-60)Marketed from Nov 20, 2019
71610-368-70	7161003687071610036870	120 TABLET in 1 BOTTLE, PLASTIC (71610-368-70)Marketed from Dec 4, 2019
71610-368-75	7161003687571610036875	150 TABLET in 1 BOTTLE, PLASTIC (71610-368-75)Marketed from Apr 23, 2020
71610-368-80	7161003688071610036880	180 TABLET in 1 BOTTLE, PLASTIC (71610-368-80)Marketed from Apr 3, 2020
71610-368-92	7161003689271610036892	270 TABLET in 1 BOTTLE, PLASTIC (71610-368-92)Marketed from Dec 4, 2019

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 — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077856
Marketing start: Feb 15, 2018
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 71610-368_24759da4-f035-bb20-e063-6294a90abca9SPL ID 24759da4-f035-bb20-e063-6294a90abca9SPL set ID 66bf60fa-61ac-47a7-a081-36077af9007eRxCUI 197527UNII 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

N471610036810 followed by a unit qualifier and the quantity

Package 71610-0368-10. 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 Oct 14, 2024.

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. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may re-establish efficacy. 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 as…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-368

What is NDC 71610-368?: 71610-368 is the product NDC for Clonazepam, Clonazepam .5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 16 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 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 .5 mg/1	TabletOral	Major Pharmaceuticals	0904-7227
Clonazepam	Clonazepam 1 mg/1	TabletOral	Major Pharmaceuticals	0904-7728
Clonazepam	Clonazepam .5 mg/1	TabletOral	Solco Healthcare LLC	43547-406
Clonazepam	Clonazepam 1 mg/1	TabletOral	Solco Healthcare LLC	43547-407
Clonazepam	Clonazepam 2 mg/1	TabletOral	Solco Healthcare LLC	43547-408
Clonazepam	Clonazepam .5 mg/1	TabletOral	AvPAK	50268-173
Clonazepam	Clonazepam 1 mg/1	TabletOral	AvPAK	50268-174
Clonazepam	Clonazepam 2 mg/1	TabletOral	AvPAK	50268-175
Clonazepam	Clonazepam .5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-4318
Clonazepam	Clonazepam 1 mg/1	TabletOral	Cardinal Health 107, LLC	55154-4319
Clonazepam	Clonazepam .5 mg/1	TabletOral	American Health Packaging	60687-861
Clonazepam	Clonazepam 1 mg/1	TabletOral	American Health Packaging	60687-872
Clonazepam	Clonazepam 1 mg/1	TabletOral	Bryant Ranch Prepack	63629-1116
Clonazepam	Clonazepam .5 mg/1	TabletOral	Bryant Ranch Prepack	63629-1201
Clonazepam	Clonazepam .5 mg/1	TabletOral	Bryant Ranch Prepack	63629-1202
Clonazepam	Clonazepam .5 mg/1	TabletOral	Bryant Ranch Prepack	63629-1203
Clonazepam	Clonazepam 1 mg/1	TabletOral	Bryant Ranch Prepack	63629-1205
Clonazepam	Clonazepam 2 mg/1	TabletOral	Bryant Ranch Prepack	63629-1206
Clonazepam	Clonazepam 2 mg/1	TabletOral	Bryant Ranch Prepack	63629-1207
Clonazepam	Clonazepam 1 mg/1	TabletOral	Bryant Ranch Prepack	63629-8988

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