What is NDC 69452-561?

69452-561 is the product NDC for olanzapine, Olanzapine 5 mg/1 tablet, orally disintegrating, listed with the FDA by Bionpharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Bionpharma Inc., NDC labeler code 69452. 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 69452-561 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-561Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0561Add 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
69452-561-13	6945205611369452056113	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (69452-561-13)Marketed from Jul 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): olanzapine
Generic name (nonproprietary): olanzapine
Active ingredients: Olanzapine — 5 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Bionpharma Inc.NDC labeler code 69452
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202937
Marketing start: Jul 1, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 69452-561_f836e1a2-2082-49cf-bf45-34e36c120c58SPL ID f836e1a2-2082-49cf-bf45-34e36c120c58SPL set ID 8f485576-a4c4-45d4-816f-2e59fce9f517RxCUI 312076, 314155, 351107, 351108UNII 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

N469452056113 followed by a unit qualifier and the quantity

Package 69452-0561-13. 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 Jul 1, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Olanzapine is an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. ( 1.1 ) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6 week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 13 to 17): Efficacy was established in one 6 week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2 ) Adults: Effic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69452-561

What is NDC 69452-561?: 69452-561 is the product NDC for olanzapine, Olanzapine 5 mg/1 tablet, orally disintegrating, listed with the FDA by Bionpharma Inc.. 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?: Bionpharma Inc., NDC labeler code 69452. 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 15 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-563	69452-0563-13
olanzapine	Olanzapine 10 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-562	69452-0562-13
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
Olanzapine	Olanzapine 7.5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0363	67046-0363-03

All 206 olanzapine NDCs

Other NDCs under ANDA 202937

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

FDA NDC Directory listings under ANDA 202937
Product	Strength	Form · route	Labeler	Product NDC
olanzapine	Olanzapine 10 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-562
olanzapine	Olanzapine 15 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-563
olanzapine	Olanzapine 20 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-564