NDC codes

FDA NDC Directory
Product NDC (as listed)65862-657Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0657Add 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
65862-657-03658620657033 BLISTER PACK in 1 CARTON (65862-657-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-657-10)Marketed from May 15, 2014

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 — 10 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203708
Marketing start
Listing expires
Identifiers
Product ID 65862-657_b691262a-e798-4bc7-985c-a047495bfd99SPL ID b691262a-e798-4bc7-985c-a047495bfd99SPL set ID 4d768cfe-3b20-4127-95b9-b4151b28afccRxCUI 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

N465862065703 followed by a unit qualifier and the quantity

Package 65862-0657-03. 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 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: Efficacy w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-657

What is NDC 65862-657?
65862-657 is the product NDC for Olanzapine, Olanzapine 10 mg/1 tablet, orally disintegrating, listed with the FDA by Aurobindo Pharma Limited. 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?
Aurobindo Pharma Limited, NDC labeler code 65862. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralCoupler LLC67046-069067046-0690-03
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-472970518-4729-00
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-669355154-6693-00
olanzapineOlanzapine 20 mg/1Tablet, Orally disintegratingOralBionpharma Inc.69452-56469452-0564-13
olanzapineOlanzapine 15 mg/1Tablet, Orally disintegratingOralBionpharma Inc.69452-56369452-0563-13
olanzapineOlanzapine 5 mg/1Tablet, Orally disintegratingOralBionpharma Inc.69452-56169452-0561-13
olanzapineOlanzapine 10 mg/1Tablet, Orally disintegratingOralBionpharma Inc.69452-56269452-0562-13
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-06187441-0061-01
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-06287441-0062-01
OlanzapineOlanzapine 20 mg/1Tablet, Film coatedOralCoupler LLC67046-007267046-0072-03

All 206 Olanzapine NDCs

Other NDCs under ANDA 203708

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

FDA NDC Directory listings under ANDA 203708
ProductStrengthForm · routeLabelerProduct NDC
OlanzapineOlanzapine 5 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited65862-656
OlanzapineOlanzapine 15 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited65862-658
OlanzapineOlanzapine 20 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited65862-659

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in