NDC codes

FDA NDC Directory
Product NDC (as listed)0781-3159Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-3159Add 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
0781-3159-72007813159721 VIAL in 1 CARTON (0781-3159-72) / 2 mL in 1 VIALMarketed from Oct 24, 2011

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, For solution
Route
Intramuscular
Labeler
Sandoz Inc
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201588
Marketing start
Listing expires
Identifiers
Product ID 0781-3159_e958c285-a1f2-4f4f-a864-50133543f41cSPL ID e958c285-a1f2-4f4f-a864-50133543f41cSPL set ID 1e9666ef-4271-4834-8496-ccb3125d83dbRxCUI 485968UNII N7U69T4SZRUPC 0307813159728
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

N400781315972 followed by a unit qualifier and the quantity

Package 00781-3159-72. 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)

Olanzapine for injection is an atypical antipsychotic indicated: • 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 Olanzapine for Injection: 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 IM 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201588

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

FDA NDC Directory listings under ANDA 201588
ProductStrengthForm · routeLabelerProduct NDC
OlanzapineOlanzapine 10 mg/2mLInjection, Powder, For solutionIntramuscularSandoz Inc0781-9105

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