What is NDC 72189-578?

72189-578 is the product NDC for Olanzapine, Olanzapine 7.5 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Olanzapine?

205 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Olanzapine NDC 72189-578 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-578Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0578Add 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
72189-578-30	72189057830	30 TABLET, FILM COATED in 1 BOTTLE (72189-578-30)Marketed from Sep 17, 2024

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): Olanzapine
Generic name (nonproprietary): olanzapine
Active ingredients: Olanzapine — 7.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202862
Marketing start: Sep 17, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 72189-578_22528ae1-e370-48e1-e063-6294a90a3dd2SPL ID 22528ae1-e370-48e1-e063-6294a90a3dd2SPL set ID 22528ae1-e36f-48e1-e063-6294a90a3dd2RxCUI 312079UNII N7U69T4SZR
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

N472189057830 followed by a unit qualifier and the quantity

Package 72189-0578-30. 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 Sep 17, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

1.1 Schizophrenia Oral olanzapine tablets are indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. In adolescent patients with schizophrenia (ages 13-17), efficacy was established in one 6-week trial [see Clinical Studies (14.1)]. When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider pres…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-578

What is NDC 72189-578?: 72189-578 is the product NDC for Olanzapine, Olanzapine 7.5 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Olanzapine.
What is the active ingredient?: Olanzapine.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Olanzapine?: 205 other product NDCs are listed under this name. See all Olanzapine 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 Olanzapine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0690	67046-0690-03
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4729	70518-4729-00
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-6693	55154-6693-00
olanzapine	Olanzapine 10 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-562	69452-0562-13
olanzapine	Olanzapine 5 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-561	69452-0561-13
olanzapine	Olanzapine 15 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-563	69452-0563-13
olanzapine	Olanzapine 20 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-564	69452-0564-13
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-061	87441-0061-01
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-062	87441-0062-01
Olanzapine	Olanzapine 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0072	67046-0072-03

All 206 Olanzapine NDCs

Other NDCs under ANDA 202862

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

FDA NDC Directory listings under ANDA 202862
Product	Strength	Form · route	Labeler	Product NDC
Olanzapine	Olanzapine 7.5 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-069
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-070
Olanzapine	Olanzapine 15 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-071
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-067
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-068
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1760
Olanzapine	Olanzapine 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0072
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4729
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7161
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0921
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0935
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8243
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-340
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0525
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8244
Olanzapine	Olanzapine 20 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-341
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-364
Olanzapine	Olanzapine 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2337
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8245
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-478

Showing 20 of 38.