What is NDC 0517-0955?

0517-0955 is the product NDC for Olanzapine, Olanzapine 10 mg/2mL injection, powder, lyophilized, for solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

American Regent, Inc., NDC labeler code 0517. 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 0517-0955 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0517-0955Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00517-0955Add 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
0517-0955-01	0051709550100517095501	1 VIAL, GLASS in 1 CARTON (0517-0955-01) / 2 mL in 1 VIAL, GLASSMarketed from Jun 27, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/2mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intramuscular
Labeler: American Regent, Inc.NDC labeler code 0517
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201741
Marketing start: Jun 27, 2012
Listing expires: Dec 31, 2027
Identifiers: Product ID 0517-0955_9e02e2b0-cac8-4917-ad26-6d70e86f1b30SPL ID 9e02e2b0-cac8-4917-ad26-6d70e86f1b30SPL set ID e9ac2bd3-dbff-4b1a-952f-da3909c6e4eeRxCUI 485968UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400517095501 followed by a unit qualifier and the quantity

Package 00517-0955-01. 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 Mar 1, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Olanzapine for injection is an atypical antipsychotic indicated for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. ( 1.4 ) Efficacy was established in three 1-day trials in adults. ( 14.3 ) 1.4 Agitation Associated with Schizophrenia and Bipolar I Mania Olanzapine for injection is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania. Efficacy was demonstrated in 3 short-term (24 hours of intramuscular treatment) placebo-controlled trials in agitated adult inpatients with: schizophrenia or bipolar I disorder (manic or mixed episodes) [see Clinical Studies ( 14.3 )]. “Psychomotor agitation” is defined in DSM-IV a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0517-0955

What is NDC 0517-0955?: 0517-0955 is the product NDC for Olanzapine, Olanzapine 10 mg/2mL injection, powder, lyophilized, for solution, listed with the FDA by American Regent, 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?: American Regent, Inc., NDC labeler code 0517. 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 5 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-561	69452-0561-13
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

All 206 Olanzapine NDCs