Prescription drug · NDA
ZYPREXA Zydis (Olanzapine) NDC 61269-653
Olanzapine 20 mg/1 · Tablet, Orally disintegrating · Oral · H2-Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-653-35 | 6126906533561269065335 | 30 DOSE PACK in 1 CARTON (61269-653-35) / 1 BLISTER PACK in 1 DOSE PACK (61269-653-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Sep 1, 2001 |
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)
- ZYPREXA ZydisSuffix: Zydis
- Generic name (nonproprietary)
- olanzapine
- Active ingredients
- Olanzapine — 20 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- H2-Pharma LLCNDC labeler code 61269
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021086
- Marketing start
- Listing expires
- Identifiers
- Product ID 61269-653_b23e8030-2d91-4970-b001-c13e5c94204bSPL ID b23e8030-2d91-4970-b001-c13e5c94204b
- 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
N461269065335followed by a unit qualifier and the quantityPackage 61269-0653-35. 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.
About NDC 61269-653
- What is NDC 61269-653?
- 61269-653 is the product NDC for ZYPREXA Zydis (olanzapine), Olanzapine 20 mg/1 tablet, orally disintegrating, listed with the FDA by H2-Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ZYPREXA Zydis (Olanzapine).
- What is the active ingredient?
- Olanzapine.
- Who is the labeler?
- H2-Pharma LLC, NDC labeler code 61269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ZYPREXA Zydis?
- 3 other product NDCs are listed under this name. See all ZYPREXA Zydis NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ZYPREXA Zydis products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ZYPREXA Zydisolanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | H2-Pharma LLC | 61269-652 | 61269-0652-35 |
| ZYPREXA Zydisolanzapine | Olanzapine 5 mg/1 | Tablet, Orally disintegratingOral | H2-Pharma LLC | 61269-650 | 61269-0650-35 |
| ZYPREXA Zydisolanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | H2-Pharma LLC | 61269-651 | 61269-0651-35 |
Other NDCs under NDA 021086
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 |
|---|---|---|---|---|
| ZYPREXA Zydisolanzapine | Olanzapine 5 mg/1 | Tablet, Orally disintegratingOral | H2-Pharma LLC | 61269-650 |
| ZYPREXA Zydisolanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | H2-Pharma LLC | 61269-651 |
| ZYPREXA Zydisolanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | H2-Pharma LLC | 61269-652 |