NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6377Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6377Add 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
0904-6377-6100904637761100 BLISTER PACK in 1 CARTON (0904-6377-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 23, 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
Olanzapine — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076255
Marketing start
Listing expires
Identifiers
Product ID 0904-6377_58bb9389-facb-41ec-ad0e-5b869077fa74SPL ID 58bb9389-facb-41ec-ad0e-5b869077fa74SPL set ID 0ecbf540-572e-4ca4-b694-18ca1cd1c194RxCUI 312078, 314154UNII 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

N400904637761 followed by a unit qualifier and the quantity

Package 00904-6377-61. 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 6week 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 ) • Adu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-6377

What is NDC 0904-6377?
0904-6377 is the product NDC for Olanzapine, Olanzapine 5 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. 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?
Major Pharmaceuticals, NDC labeler code 0904. 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 20 mg/1Tablet, Orally disintegratingOralBionpharma Inc.69452-56469452-0564-13
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 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 076255

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

FDA NDC Directory listings under ANDA 076255
ProductStrengthForm · routeLabelerProduct NDC
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-723
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-740
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0714
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1605
OlanzapineOlanzapine 7.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1611
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1635
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0110
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc.43598-166
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-6889
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc.43598-164
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-6881
OlanzapineOlanzapine 7.5 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc.43598-165
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8722
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-460
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1764
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2627
OlanzapineOlanzapine 7.5 mg/1Tablet, Film coatedOralCoupler LLC67046-0363
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-061
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-062
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Ltd.55111-163

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Olanzapine NDC 0904-6377 | National Drug Code | Med-Code