Prescription drug · ANDA
Olanzapine NDC 63187-364
Olanzapine 10 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-364-30 | 6318703643063187036430 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-364-30)Marketed from Aug 1, 2016 | |
| 63187-364-60 | 6318703646063187036460 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-364-60)Marketed from Aug 1, 2016 | |
| 63187-364-90 | 6318703649063187036490 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-364-90)Marketed from Aug 1, 2016 |
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
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202862
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-364_7af11d56-ef6d-47b7-8119-c30c31ef9cf4SPL ID 7af11d56-ef6d-47b7-8119-c30c31ef9cf4SPL set ID 1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572RxCUI 314154UNII N7U69T4SZRUPC 0363187364304
- 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
N463187036430followed by a unit qualifier and the quantityPackage 63187-0364-30. 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 hyperlipidemia 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 ) · …
Excerpt only. Read the full label for complete information.
About NDC 63187-364
- What is NDC 63187-364?
- 63187-364 is the product NDC for Olanzapine, Olanzapine 10 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 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?
- Proficient Rx LP, NDC labeler code 63187. 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.
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 15 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-563 | 69452-0563-13 |
| 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 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 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8243 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8244 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8245 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8246 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8566 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-067 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-068 |
| Olanzapine | Olanzapine 7.5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-069 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-070 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-071 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-072 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-340 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0072 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0525 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0690 |
| Olanzapine | Olanzapine 7.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1144 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2262 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7161 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0921 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0935 |
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