NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8718Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8718Add 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
63629-8718-1636298718016362987180130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-8718-1)Marketed from Oct 24, 2011

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 — 10 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091265
Marketing start
Listing expires
Identifiers
Product ID 63629-8718_3364e551-5f70-d3ba-e063-6394a90afbe1SPL ID 3364e551-5f70-d3ba-e063-6394a90afbe1SPL set ID ed93d6b9-912a-444a-a695-439d0bfb877aRxCUI 312076UNII 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

N463629871801 followed by a unit qualifier and the quantity

Package 63629-8718-01. 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 bipol…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8718

What is NDC 63629-8718?
63629-8718 is the product NDC for Olanzapine, Olanzapine 10 mg/1 tablet, orally disintegrating, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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 091265

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

FDA NDC Directory listings under ANDA 091265
ProductStrengthForm · routeLabelerProduct NDC
OlanzapineOlanzapine 5 mg/1Tablet, Orally disintegratingOralGolden State Medical Supply, Inc.51407-261
OlanzapineOlanzapine 10 mg/1Tablet, Orally disintegratingOralGolden State Medical Supply, Inc.51407-262
OlanzapineOlanzapine 15 mg/1Tablet, Orally disintegratingOralGolden State Medical Supply, Inc.51407-263
OlanzapineOlanzapine 20 mg/1Tablet, Orally disintegratingOralGolden State Medical Supply, Inc.51407-264
OlanzapineOlanzapine 5 mg/1Tablet, Orally disintegratingOralApotex Corp.60505-3275
OlanzapineOlanzapine 10 mg/1Tablet, Orally disintegratingOralApotex Corp.60505-3276
OlanzapineOlanzapine 15 mg/1Tablet, Orally disintegratingOralApotex Corp.60505-3277
OlanzapineOlanzapine 20 mg/1Tablet, Orally disintegratingOralApotex Corp.60505-3278
OlanzapineOlanzapine 15 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack63629-8714
OlanzapineOlanzapine 5 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack63629-8717
OlanzapineOlanzapine 5 mg/1Tablet, Orally disintegratingOralCoupler LLC67046-1550
OlanzapineOlanzapine 10 mg/1Tablet, Orally disintegratingOralCoupler LLC67046-1565

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