Prescription drug · ANDA
Olanzapine NDC 70518-1635
Olanzapine 10 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1635-0 | 70518163500 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1635-0)Marketed from Nov 6, 2018 | |
| 70518-1635-1 | 70518163501 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1635-1)Marketed from Dec 6, 2022 | |
| 70518-1635-2 | 70518163502 | 60 TABLET, FILM COATED in 1 BLISTER PACK (70518-1635-2)Marketed from Sep 21, 2026 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076255
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-1635_5bfd42a8-1295-32b2-e063-6294a90a89a9SPL ID 5bfd42a8-1295-32b2-e063-6294a90a89a9
- 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
N470518163500followed by a unit qualifier and the quantityPackage 70518-1635-00. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 076255
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 7.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0363 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2627 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Ltd. | 55111-163 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-525 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-061 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4012 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-062 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0539 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0540 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-723 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-740 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0714 |
| Olanzapine | Olanzapine 7.5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1611 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1605 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6376 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-460 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-164 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6377 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-6889 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8722 |
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