Prescription drug · ANDA
Olanzapine NDC 72303-0840
Olanzapine 20 mg/1 · Tablet · Oral · HEC Pharm USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72303-0840-1 | 72303084001 | 30 TABLET in 1 BOTTLE, PLASTIC (72303-0840-1)Marketed from Nov 30, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Route
- Oral
- Labeler
- HEC Pharm USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206238
- Marketing start
- Listing expires
- Identifiers
- Product ID 72303-0840_4d2e9776-65f4-cb00-e063-6394a90a1bf7SPL ID 4d2e9776-65f4-cb00-e063-6394a90a1bf7SPL set ID 4d34f8f3-edc8-0a68-e063-6394a90a9c1fRxCUI 200034, 283639, 312077, 312078, 312079, 314154UNII N7U69T4SZRUPC 0372303083616, 0372303083913, 0372303083814
- 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
N472303084001followed by a unit qualifier and the quantityPackage 72303-0840-01. 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 years to 17 years): 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206238
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 | TabletOral | HEC Pharm USA Inc. | 72303-0835 |
| Olanzapine | Olanzapine 15 mg/1 | TabletOral | HEC Pharm USA Inc. | 72303-0839 |
| Olanzapine | Olanzapine 5 mg/1 | TabletOral | HEC Pharm USA Inc. | 72303-0836 |
| Olanzapine | Olanzapine 7.5 mg/1 | TabletOral | HEC Pharm USA Inc. | 72303-0837 |
| Olanzapine | Olanzapine 10 mg/1 | TabletOral | HEC Pharm USA Inc. | 72303-0838 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.