NDC codes

FDA NDC Directory
Product NDC (as listed)72603-912Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72603-0912Add 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
72603-912-017260309120172603091201100 TABLET in 1 BOTTLE (72603-912-01)Marketed from Aug 1, 2026

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 — 50 mg/1
Dosage form
Tablet
Route
Oral
Labeler
NorthStar Rx LLCNDC labeler code 72603
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206433
Marketing start
Listing expires
Identifiers
Product ID 72603-912_61fe53d5-ed5c-4e45-9189-709d08d386cbSPL ID 61fe53d5-ed5c-4e45-9189-709d08d386cbSPL set ID 61fe53d5-ed5c-4e45-9189-709d08d386cbRxCUI 197535, 197536, 309374, 429212UNII J60AR2IKICUPC 0372603912012, 0372603911015
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

N472603091201 followed by a unit qualifier and the quantity

Package 72603-0912-01. 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 . 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 72603-912

What is NDC 72603-912?
72603-912 is the product NDC for Clozapine, Clozapine 50 mg/1 tablet, listed with the FDA by NorthStar Rx LLC. It has 1 package NDC, 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?
NorthStar Rx LLC, NDC labeler code 72603. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ClozapineClozapine 25 mg/1TabletOralNorthStar Rx LLC72603-91172603-0911-01
ClozapineClozapine 100 mg/1TabletOralNorthStar Rx LLC72603-91372603-0913-0172603-0913-02
ClozapineClozapine 200 mg/1TabletOralNorthStar Rx LLC72603-91472603-0914-01
ClozapineClozapine 100 mg/1Tablet, Orally disintegratingOralSafecor Health, LLC48433-02248433-0022-04
ClozapineClozapine 25 mg/1TabletOralSafecor Health LLC48433-02348433-0023-20
ClozapineClozapine 100 mg/1TabletOralSafecor Health LLC48433-02448433-0024-20
ClozapineClozapine 200 mg/1TabletOralSafecor Health LLC48433-02548433-0025-20
ClozapineClozapine 12.5 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited59651-26059651-0260-01
ClozapineClozapine 25 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited59651-26159651-0261-0159651-0261-48
ClozapineClozapine 100 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited59651-26259651-0262-0159651-0262-48

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
ProductStrengthForm · routeLabelerProduct NDC
ClozapineClozapine 100 mg/1TabletOralMajor Pharmaceuticals0904-7087
ClozapineClozapine 200 mg/1TabletOralMajor Pharmaceuticals0904-7088
ClozapineClozapine 25 mg/1TabletOralMajor Pharmaceuticals0904-7089
ClozapineClozapine 50 mg/1TabletOralMajor Pharmaceuticals0904-7406
ClozapineClozapine 100 mg/1TabletOralCardinal Health 107, LLC55154-3568
ClozapineClozapine 25 mg/1TabletOralAmerican Health Packaging60687-404
ClozapineClozapine 100 mg/1TabletOralAmerican Health Packaging60687-415
ClozapineClozapine 200 mg/1TabletOralAmerican Health Packaging60687-426
ClozapineClozapine 50 mg/1TabletOralAmerican Health Packaging60687-548
ClozapineClozapine 25 mg/1TabletOralAurobindo Pharma Limited65862-844
ClozapineClozapine 100 mg/1TabletOralAurobindo Pharma Limited65862-846
ClozapineClozapine 200 mg/1TabletOralAurobindo Pharma Limited65862-847
ClozapineClozapine 25 mg/1TabletOralNorthStar Rx LLC72603-911
ClozapineClozapine 100 mg/1TabletOralNorthStar Rx LLC72603-913
ClozapineClozapine 200 mg/1TabletOralNorthStar Rx LLC72603-914

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