Prescription drug · ANDA

Olanzapine NDC 33342-067

Olanzapine 2.5 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)33342-067Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0067Add 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
33342-067-073334200670730 TABLET, FILM COATED in 1 BOTTLE (33342-067-07)Marketed from Aug 22, 2014
33342-067-1133342006711100 TABLET, FILM COATED in 1 BOTTLE (33342-067-11)Marketed from Aug 22, 2014
33342-067-123334200671210 BLISTER PACK in 1 CARTON (33342-067-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 22, 2014
33342-067-44333420067441000 TABLET, FILM COATED in 1 BOTTLE (33342-067-44)Marketed from Aug 22, 2014

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 — 2.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202862
Marketing start
Listing expires
Identifiers
Product ID 33342-067_2b861570-6b18-4b2b-89aa-29ebde7770f5SPL ID 2b861570-6b18-4b2b-89aa-29ebde7770f5SPL set ID 8e095987-bdea-42f2-9550-c7155cf07d30RxCUI 200034, 283639, 312077, 312078, 312079, 314154UNII N7U69T4SZRUPC 0333342067074, 0333342070074, 0333342069078, 0333342072078, 0333342071071, 0333342068071
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

N433342006707 followed by a unit qualifier and the quantity

Package 33342-0067-07. 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 13-17): 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 ) · Ad…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-067

What is NDC 33342-067?
33342-067 is the product NDC for Olanzapine, Olanzapine 2.5 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, 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?
Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 202862

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

FDA NDC Directory listings under ANDA 202862
ProductStrengthForm · routeLabelerProduct NDC
OlanzapineOlanzapine 20 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-341
OlanzapineOlanzapine 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2337
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralProficient Rx LP63187-364
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2375
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralDirect_Rx72189-478
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0534
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralCoupler LLC67046-0690
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9661
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8566
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralRedpharm Drug67296-2262
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralProficient Rx LP71205-487
OlanzapineOlanzapine 7.5 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-156
OlanzapineOlanzapine 2.5 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-154
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-155
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-157
OlanzapineOlanzapine 15 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-158
OlanzapineOlanzapine 20 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-159
OlanzapineOlanzapine 7.5 mg/1Tablet, Film coatedOralCoupler LLC67046-1144
OlanzapineOlanzapine 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2368
OlanzapineOlanzapine 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2698

Showing 20 of 38.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in
Olanzapine NDC 33342-067 | National Drug Code | Med-Code