NDC codes

FDA NDC Directory
Product NDC (as listed)0093-5248Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-5248Add 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
0093-5248-650009352486530 BLISTER PACK in 1 CARTON (0093-5248-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5248-19)Marketed from Feb 24, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Olanzapine20 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077243
Marketing start
Listing expires
Identifiers
Product ID 0093-5248_379692bf-82b3-48f3-8d1f-5a27949ce441SPL ID 379692bf-82b3-48f3-8d1f-5a27949ce441SPL set ID dd0b2525-4e2f-44fc-9302-0ae4ebb1e135RxCUI 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

N400093524865 followed by a unit qualifier and the quantity

Package 00093-5248-65. 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 orally disintegrating 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 bipola

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077243

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

FDA NDC Directory listings under ANDA 077243
ProductStrengthForm · routeLabelerProduct NDC
OlanzapineOlanzapine 5 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals USA, Inc.0093-5245
OlanzapineOlanzapine 10 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals USA, Inc.0093-5246
OlanzapineOlanzapine 15 mg/1Tablet, Orally disintegratingOralTeva Pharmaceuticals USA, Inc.0093-5247

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