NDC codes

FDA NDC Directory
Product NDC (as listed)63187-340Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0340Add 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
63187-340-0663187034006631870340066 TABLET, FILM COATED in 1 BOTTLE (63187-340-06)Marketed from Feb 21, 2023
63187-340-30631870340306318703403030 TABLET, FILM COATED in 1 BOTTLE (63187-340-30)Marketed from Feb 2, 2015
63187-340-60631870340606318703406060 TABLET, FILM COATED in 1 BOTTLE (63187-340-60)Marketed from Feb 21, 2023
63187-340-90631870340906318703409090 TABLET, FILM COATED in 1 BOTTLE (63187-340-90)Marketed from Feb 21, 2023

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 — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202862
Marketing start
Listing expires
Identifiers
Product ID 63187-340_c6e1cbe2-4d81-4b7c-b948-d64d9b3527a7SPL ID c6e1cbe2-4d81-4b7c-b948-d64d9b3527a7SPL set ID ce66d545-015b-41d5-80c3-964d78e36bfdRxCUI 312078UNII N7U69T4SZRUPC 0363187340063
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

N463187034006 followed by a unit qualifier and the quantity

Package 63187-0340-06. 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 13-17): 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 hyperlipidemia 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 63187-340

What is NDC 63187-340?
63187-340 is the product NDC for Olanzapine, Olanzapine 5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, 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?
Proficient Rx LP, NDC labeler code 63187. 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 202862

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

FDA NDC Directory listings under ANDA 202862
ProductStrengthForm · routeLabelerProduct NDC
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8243
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8244
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8245
OlanzapineOlanzapine 20 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8246
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8566
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-067
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-068
OlanzapineOlanzapine 7.5 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-069
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-070
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-071
OlanzapineOlanzapine 20 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-072
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralProficient Rx LP63187-364
OlanzapineOlanzapine 20 mg/1Tablet, Film coatedOralCoupler LLC67046-0072
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralCoupler LLC67046-0525
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralCoupler LLC67046-0690
OlanzapineOlanzapine 7.5 mg/1Tablet, Film coatedOralCoupler LLC67046-1144
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralRedpharm Drug67296-2262
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7161
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0921
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0935

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