Prescription drug · NDA
ZYPREXA Relprevv (Olanzapine pamoate) NDC 61269-660
Kit · Intramuscular · H2-Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-660-20 | 6126906602061269066020 | 1 KIT in 1 CARTON (61269-660-20) * 1.4 mL in 1 VIAL * 3 mL in 1 VIALMarketed from Mar 1, 2010 |
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 RelprevvSuffix: Relprevv
- Generic name (nonproprietary)
- olanzapine pamoate
- Dosage form
- Kit
- Route
- Intramuscular
- Labeler
- H2-Pharma LLCNDC labeler code 61269
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022173
- Marketing start
- Listing expires
- Identifiers
- Product ID 61269-660_9c56e9db-742e-4263-96b4-d92064f9babaSPL ID 9c56e9db-742e-4263-96b4-d92064f9babaSPL set ID 11544cba-64a9-49cb-8d74-da228053b252RxCUI 1718925, 1718928, 1718930, 1718932, 1718934, 1718936
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N461269066020followed by a unit qualifier and the quantityPackage 61269-0660-20. 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)
ZYPREXA RELPREVV is available only through a restricted distribution program [see Warnings and Precautions ( 5.2 )] . ZYPREXA RELPREVV must not be dispensed directly to a patient. For a patient to receive treatment, the prescriber, healthcare setting, patient, and pharmacy must all be enrolled in the ZYPREXA RELPREVV REMS. To enroll, call 1-877-772-9390. ZYPREXA ® RELPREVV™ is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia. ( 1.1 ) Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults. ( 14.1 ) 1.1 Schizophrenia ZYPREXA RELPREVV is indicated …
Excerpt only. Read the full label for complete information.
About NDC 61269-660
- What is NDC 61269-660?
- 61269-660 is the product NDC for ZYPREXA Relprevv (olanzapine pamoate) kit, 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 Relprevv (Olanzapine pamoate).
- 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 Relprevv?
- 2 other product NDCs are listed under this name. See all ZYPREXA Relprevv NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ZYPREXA Relprevv 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 Relprevvolanzapine pamoate | — | KitIntramuscular | H2-Pharma LLC | 61269-661 | 61269-0661-20 |
| ZYPREXA Relprevvolanzapine pamoate | — | KitIntramuscular | H2-Pharma LLC | 61269-662 | 61269-0662-20 |
Other NDCs under NDA 022173
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 Relprevvolanzapine pamoate | — | KitIntramuscular | H2-Pharma LLC | 61269-661 |
| ZYPREXA Relprevvolanzapine pamoate | — | KitIntramuscular | H2-Pharma LLC | 61269-662 |