NDC codes

FDA NDC Directory
Product NDC (as listed)72303-0839Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72303-0839Add 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
72303-0839-1723030839017230308390130 TABLET in 1 BOTTLE, PLASTIC (72303-0839-1)Marketed from Nov 30, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 15 mg/1
Dosage form
Tablet
Route
Oral
Labeler
HEC Pharm USA Inc.NDC labeler code 72303
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206238
Marketing start
Listing expires
Identifiers
Product ID 72303-0839_4d2e9776-65f4-cb00-e063-6394a90a1bf7SPL ID 4d2e9776-65f4-cb00-e063-6394a90a1bf7SPL set ID 4d34f8f3-edc8-0a68-e063-6394a90a9c1fRxCUI 200034, 283639, 312077, 312078, 312079, 314154UNII N7U69T4SZRUPC 0372303083616, 0372303083913, 0372303083814
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

N472303083901 followed by a unit qualifier and the quantity

Package 72303-0839-01. 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 . 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 years to 17 years): 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)

About NDC 72303-0839

What is NDC 72303-0839?
72303-0839 is the product NDC for Olanzapine, Olanzapine 15 mg/1 tablet, listed with the FDA by HEC Pharm USA 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?
HEC Pharm USA Inc., NDC labeler code 72303. 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 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 20 mg/1Tablet, Orally disintegratingOralBionpharma Inc.69452-56469452-0564-13
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 206238

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

FDA NDC Directory listings under ANDA 206238
ProductStrengthForm · routeLabelerProduct NDC
OlanzapineOlanzapine 2.5 mg/1TabletOralHEC Pharm USA Inc.72303-0835
OlanzapineOlanzapine 5 mg/1TabletOralHEC Pharm USA Inc.72303-0836
OlanzapineOlanzapine 7.5 mg/1TabletOralHEC Pharm USA Inc.72303-0837
OlanzapineOlanzapine 10 mg/1TabletOralHEC Pharm USA Inc.72303-0838
OlanzapineOlanzapine 20 mg/1TabletOralHEC Pharm USA Inc.72303-0840

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