What is NDC 16729-141?

16729-141 is the product NDC for Clozapine, Clozapine 25 mg/1 tablet, listed with the FDA by Accord Healthcare Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Accord Healthcare Inc., NDC labeler code 16729. 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 16729-141 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-141Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0141Add 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	Copy
16729-141-01	1672901410116729014101	100 TABLET in 1 BOTTLE (16729-141-01)Marketed from Apr 10, 2017
16729-141-16	1672901411616729014116	500 TABLET in 1 BOTTLE (16729-141-16)Marketed from Jun 8, 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): Clozapine
Generic name (nonproprietary): clozapine
Active ingredients: Clozapine — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Accord Healthcare Inc.NDC labeler code 16729
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202873
Marketing start: Apr 10, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 16729-141_40aa4dd3-36ca-1132-e063-6394a90a268dSPL ID 40aa4dd3-36ca-1132-e063-6394a90a268dSPL set ID 25c0c6d5-f7b0-48e4-e054-00144ff8d46cRxCUI 197535, 197536UNII J60AR2IKIC
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

N416729014101 followed by a unit qualifier and the quantity

Package 16729-0141-01. 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 Oct 8, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Clozapine tablets is 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 patients…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16729-141

What is NDC 16729-141?: 16729-141 is the product NDC for Clozapine, Clozapine 25 mg/1 tablet, listed with the FDA by Accord Healthcare Inc.. It has 2 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?: Accord Healthcare Inc., NDC labeler code 16729. 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 202873

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

FDA NDC Directory listings under ANDA 202873
Product	Strength	Form · route	Labeler	Product NDC
Clozapine	Clozapine 100 mg/1	TabletOral	Accord Healthcare Inc.	16729-142