What is NDC 65862-847?

65862-847 is the product NDC for Clozapine, Clozapine 200 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clozapine?

43 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clozapine NDC 65862-847 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-847Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0847Add 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
65862-847-01	6586208470165862084701	100 TABLET in 1 BOTTLE (65862-847-01)Marketed from Nov 29, 2016
65862-847-05	6586208470565862084705	500 TABLET in 1 BOTTLE (65862-847-05)Marketed from Nov 29, 2016
65862-847-78	6586208477865862084778	10 BLISTER PACK in 1 CARTON (65862-847-78) / 10 TABLET in 1 BLISTER PACK (65862-847-10)Marketed from Nov 29, 2016

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): Clozapine
Generic name (nonproprietary): clozapine
Active ingredients: Clozapine — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206433
Marketing start: Nov 29, 2016
Listing expires: Dec 31, 2027
Identifiers: Product ID 65862-847_a46da176-2ed3-4b9a-b06f-efab2936a5eeSPL ID a46da176-2ed3-4b9a-b06f-efab2936a5eeSPL set ID 5021d643-32d2-4167-b5d8-90870e68a787RxCUI 197535, 197536, 309374, 429212UNII J60AR2IKICUPC 0365862844019, 0365862845016
Pharmacologic class: Atypical Antipsychotic

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

N465862084701 followed by a unit qualifier and the quantity

Package 65862-0847-01. 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 Dec 17, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Clozapine tablets are an atypical antipsychotic indicated for: Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, clozapine tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment. ( 1.1 ) Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior. ( 1.2 ) 1.1 Treatment-Resistant Schizophrenia Clozapine tablets are indicated for the treatment of severely ill pat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-847

What is NDC 65862-847?: 65862-847 is the product NDC for Clozapine, Clozapine 200 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clozapine.
What is the active ingredient?: Clozapine.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clozapine?: 43 other product NDCs are listed under this name. See all Clozapine 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 Clozapine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clozapine	Clozapine 25 mg/1	TabletOral	NorthStar Rx LLC	72603-911	72603-0911-01
Clozapine	Clozapine 50 mg/1	TabletOral	NorthStar Rx LLC	72603-912	72603-0912-01
Clozapine	Clozapine 100 mg/1	TabletOral	NorthStar Rx LLC	72603-913	72603-0913-0172603-0913-02
Clozapine	Clozapine 200 mg/1	TabletOral	NorthStar Rx LLC	72603-914	72603-0914-01
Clozapine	Clozapine 100 mg/1	Tablet, Orally disintegratingOral	Safecor Health, LLC	48433-022	48433-0022-04
Clozapine	Clozapine 25 mg/1	TabletOral	Safecor Health LLC	48433-023	48433-0023-20
Clozapine	Clozapine 100 mg/1	TabletOral	Safecor Health LLC	48433-024	48433-0024-20
Clozapine	Clozapine 200 mg/1	TabletOral	Safecor Health LLC	48433-025	48433-0025-20
Clozapine	Clozapine 12.5 mg/1	Tablet, Orally disintegratingOral	Aurobindo Pharma Limited	59651-260	59651-0260-01
Clozapine	Clozapine 25 mg/1	Tablet, Orally disintegratingOral	Aurobindo Pharma Limited	59651-261	59651-0261-0159651-0261-48

All 44 Clozapine NDCs

Other NDCs under ANDA 206433

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

FDA NDC Directory listings under ANDA 206433
Product	Strength	Form · route	Labeler	Product NDC
Clozapine	Clozapine 100 mg/1	TabletOral	Major Pharmaceuticals	0904-7087
Clozapine	Clozapine 200 mg/1	TabletOral	Major Pharmaceuticals	0904-7088
Clozapine	Clozapine 25 mg/1	TabletOral	Major Pharmaceuticals	0904-7089
Clozapine	Clozapine 50 mg/1	TabletOral	Major Pharmaceuticals	0904-7406
Clozapine	Clozapine 100 mg/1	TabletOral	Cardinal Health 107, LLC	55154-3568
Clozapine	Clozapine 25 mg/1	TabletOral	American Health Packaging	60687-404
Clozapine	Clozapine 100 mg/1	TabletOral	American Health Packaging	60687-415
Clozapine	Clozapine 200 mg/1	TabletOral	American Health Packaging	60687-426
Clozapine	Clozapine 50 mg/1	TabletOral	American Health Packaging	60687-548
Clozapine	Clozapine 25 mg/1	TabletOral	Aurobindo Pharma Limited	65862-844
Clozapine	Clozapine 100 mg/1	TabletOral	Aurobindo Pharma Limited	65862-846
Clozapine	Clozapine 25 mg/1	TabletOral	NorthStar Rx LLC	72603-911
Clozapine	Clozapine 50 mg/1	TabletOral	NorthStar Rx LLC	72603-912
Clozapine	Clozapine 100 mg/1	TabletOral	NorthStar Rx LLC	72603-913
Clozapine	Clozapine 200 mg/1	TabletOral	NorthStar Rx LLC	72603-914