Prescription drug · ANDA
Olanzapine NDC 33342-086
Olanzapine 20 mg/1 · Tablet, Orally disintegrating · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-086-07 | 33342008607 | 30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-086-07)Marketed from Feb 27, 2015 | |
| 33342-086-11 | 33342008611 | 100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-086-11)Marketed from Feb 27, 2015 | |
| 33342-086-12 | 33342008612 | 10 BLISTER PACK in 1 CARTON (33342-086-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Feb 27, 2015 | |
| 33342-086-15 | 33342008615 | 500 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-086-15)Marketed from Feb 27, 2015 |
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 — 20 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203044
- Marketing start
- Listing expires
- Identifiers
- Product ID 33342-086_54e61f27-1a30-4d62-8709-f7fe4023eb0fSPL ID 54e61f27-1a30-4d62-8709-f7fe4023eb0fSPL set ID df43938a-3469-40eb-8166-f0a2fd29d6d8RxCUI 312076, 314155, 351107, 351108UNII N7U69T4SZRUPC 0333342083128, 0333342086129, 0333342084125
- 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
N433342008607followed by a unit qualifier and the quantityPackage 33342-0086-07. 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 ) Adults: Effi…
Excerpt only. Read the full label for complete information.
About NDC 33342-086
- What is NDC 33342-086?
- 33342-086 is the product NDC for Olanzapine, Olanzapine 20 mg/1 tablet, orally disintegrating, 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?
- 200 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.
Related NDCs: other Olanzapine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0690 | 67046-0690-03 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4729 | 70518-4729-00 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-6693 | 55154-6693-00 |
| olanzapine | Olanzapine 5 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-561 | 69452-0561-13 |
| olanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-562 | 69452-0562-13 |
| olanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-563 | 69452-0563-13 |
| olanzapine | Olanzapine 20 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-564 | 69452-0564-13 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-061 | 87441-0061-01 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-062 | 87441-0062-01 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0072 | 67046-0072-03 |
Other NDCs under ANDA 203044
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Orally disintegratingOral | Macleods Pharmaceuticals Limited | 33342-083 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | Macleods Pharmaceuticals Limited | 33342-084 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | Macleods Pharmaceuticals Limited | 33342-085 |