NDC codes

FDA NDC Directory
Product NDC (as listed)60505-3140Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-3140Add 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
60505-3140-0605053140006050531400010 BLISTER PACK in 1 CARTON (60505-3140-0) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 23, 2012
60505-3140-3605053140036050531400330 TABLET, FILM COATED in 1 BOTTLE (60505-3140-3)Marketed from Apr 23, 2012
60505-3140-860505314008605053140081000 TABLET, FILM COATED in 1 BOTTLE (60505-3140-8)Marketed from Apr 23, 2012

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 — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Apotex Corp.NDC labeler code 60505
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090798
Marketing start
Listing expires
Identifiers
Product ID 60505-3140_2dd39227-59ef-df97-a57e-d5a013dc132fSPL ID 2dd39227-59ef-df97-a57e-d5a013dc132fSPL set ID 3347d1c8-04c9-5ce1-8cda-b38e0412b709RxCUI 200034, 283639, 312077, 312078, 312079, 314154UNII N7U69T4SZRUPC 0360505311286, 0360505311187, 0360505311385, 0360505311484, 0360505314089, 0360505311088
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

N460505314000 followed by a unit qualifier and the quantity

Package 60505-3140-00. 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 tablets are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60505-3140

What is NDC 60505-3140?
60505-3140 is the product NDC for Olanzapine, Olanzapine 20 mg/1 tablet, film coated, listed with the FDA by Apotex Corp.. It has 3 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?
Apotex Corp., NDC labeler code 60505. 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 090798

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

FDA NDC Directory listings under ANDA 090798
ProductStrengthForm · routeLabelerProduct NDC
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-6693
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-620
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-621
OlanzapineOlanzapine 7.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-622
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-623
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-624
OlanzapineOlanzapine 20 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-625
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralApotex Corp.60505-3110
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralApotex Corp.60505-3111
OlanzapineOlanzapine 7.5 mg/1Tablet, Film coatedOralApotex Corp.60505-3112
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralApotex Corp.60505-3113
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralApotex Corp.60505-3114
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralProficient Rx LP63187-429
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralProficient Rx LP63187-453
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralProficient Rx LP63187-844
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0314
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3568
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2599
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-419
OlanzapineOlanzapine 20 mg/1Tablet, Film coatedOralProficient Rx LP82804-067

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