ZYPREXA Zydis (olanzapine) NDC 61269-651

NDC codes

FDA NDC Directory

Product NDC (as listed)61269-651Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61269-0651Add 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
61269-651-35	61269065135	30 DOSE PACK in 1 CARTON (61269-651-35) / 1 BLISTER PACK in 1 DOSE PACK (61269-651-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jun 1, 2000

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): ZYPREXA ZydisSuffix: Zydis
Generic name (nonproprietary): olanzapine
Active ingredients: Olanzapine — 10 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: H2-Pharma LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021086
Marketing start: Jun 1, 2000
Listing expires: Dec 31, 2027
Identifiers: Product ID 61269-651_40d4ed67-c51d-40d0-8a32-ecfdbf069f9aSPL ID 40d4ed67-c51d-40d0-8a32-ecfdbf069f9aSPL set ID b418946a-1ab4-4d89-a012-d94fc361a3c4RxCUI 153046, 153047, 153048, 200034, 212405, 261337, 283639, 284514, 312076, 312077, 312078, 312079, 314154, 314155, 351107, 351108, 485968, 545353, 754503, 754504, 754505, 754506UNII N7U69T4SZRUPC 0361269633300, 0361269635304, 0361269634307, 0361269630309, 0361269632303, 0361269631306
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

N461269065135 followed by a unit qualifier and the quantity

Package 61269-0651-35. 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 Feb 11, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

ZYPREXA ® (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 13-17): 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 ) …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021086

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

FDA NDC Directory listings under NDA 021086
Product	Strength	Form · route	Labeler	Product NDC
ZYPREXA Zydisolanzapine	Olanzapine 5 mg/1	Tablet, Orally disintegratingOral	H2-Pharma LLC	61269-650
ZYPREXA Zydisolanzapine	Olanzapine 15 mg/1	Tablet, Orally disintegratingOral	H2-Pharma LLC	61269-652
ZYPREXA Zydisolanzapine	Olanzapine 20 mg/1	Tablet, Orally disintegratingOral	H2-Pharma LLC	61269-653