Prescription drug · ANDA

Olanzapine NDC 63187-844

Olanzapine 5 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-844Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0844Add 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
63187-844-03631870844033 TABLET, FILM COATED in 1 BOTTLE (63187-844-03)Marketed from May 1, 2017
63187-844-306318708443030 TABLET, FILM COATED in 1 BOTTLE (63187-844-30)Marketed from Apr 23, 2012
63187-844-606318708446060 TABLET, FILM COATED in 1 BOTTLE (63187-844-60)Marketed from Apr 23, 2012
63187-844-906318708449090 TABLET, FILM COATED in 1 BOTTLE (63187-844-90)Marketed from May 1, 2017

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090798
Marketing start
Listing expires
Identifiers
Product ID 63187-844_e818889d-6a4e-473d-90cc-f817ffece059SPL ID e818889d-6a4e-473d-90cc-f817ffece059SPL set ID 7772a4c2-1fb1-412b-9e3b-ef3d693517a2RxCUI 312078UNII 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

N463187084403 followed by a unit qualifier and the quantity

Package 63187-0844-03. 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 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 coatedOralApotex Corp.60505-3110
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralApotex Corp.60505-3114
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 20 mg/1Tablet, Film coatedOralApotex Corp.60505-3140
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 15 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-624
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 20 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-625
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralProficient Rx LP63187-429
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralProficient Rx LP63187-453
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3568
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-6693
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-419
OlanzapineOlanzapine 20 mg/1Tablet, Film coatedOralProficient Rx LP82804-067
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2599
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0314

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