Prescription drug · ANDA
Olanzapine NDC 33342-070
Olanzapine 10 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-070-07 | 33342007007 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-070-07)Marketed from Aug 22, 2014 | |
| 33342-070-11 | 33342007011 | 100 TABLET, FILM COATED in 1 BOTTLE (33342-070-11)Marketed from Aug 22, 2014 | |
| 33342-070-12 | 33342007012 | 10 BLISTER PACK in 1 CARTON (33342-070-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 22, 2014 | |
| 33342-070-15 | 33342007015 | 500 TABLET, FILM COATED in 1 BOTTLE (33342-070-15)Marketed from Aug 22, 2014 | |
| 33342-070-44 | 33342007044 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-070-44)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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202862
- Marketing start
- Listing expires
- Identifiers
- Product ID 33342-070_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
N433342007007followed by a unit qualifier and the quantityPackage 33342-0070-07. 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.
Other NDCs under ANDA 202862
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 2.5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4729 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7161 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0072 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8566 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0921 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0935 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-340 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-341 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0525 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2337 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-364 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-478 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2375 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0534 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0690 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9661 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2262 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-487 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-155 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-154 |
Showing 20 of 38.