NDC codes

FDA NDC Directory
Product NDC (as listed)13668-089Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13668-0089Add 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
13668-089-0513668008905500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-089-05)Marketed from Oct 25, 2011
13668-089-301366800893030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-089-30)Marketed from Oct 25, 2011
13668-089-901366800899090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-089-90)Marketed from Oct 25, 2011

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
Olanzapine15 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091415
Marketing start
Listing expires
Identifiers
Product ID 13668-089_1a64829a-2434-4c8d-8e58-9b28758e4b88SPL ID 1a64829a-2434-4c8d-8e58-9b28758e4b88SPL set ID 2cb1bebe-0ced-46d8-bf21-c28a9acc4a15RxCUI 200034, 283639, 312076, 312077, 312078, 312079, 314154, 314155, 351107, 351108UNII N7U69T4SZRUPC 0313668088304, 0313668170306, 0313668169300, 0313668171303, 0313668168303, 0313668166309, 0313668090307, 0313668089301, 0313668167306, 0313668086300
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

N413668008905 followed by a unit qualifier and the quantity

Package 13668-0089-05. 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 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)

Other NDCs under ANDA 091415

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

FDA NDC Directory listings under ANDA 091415
ProductStrengthForm · routeLabelerProduct NDC
OlanzapineOlanzapine 10 mg/1Tablet, Orally disintegratingOralTorrent Pharmaceuticals Limited13668-088
OlanzapineOlanzapine 5 mg/1Tablet, Orally disintegratingOralTorrent Pharmaceuticals Limited13668-086
OlanzapineOlanzapine 20 mg/1Tablet, Orally disintegratingOralTorrent Pharmaceuticals Limited13668-090

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