Prescription drug · ANDA
Haloperidol Decanoate NDC 67457-410
Haloperidol decanoate 50 mg/mL · Injection · Intramuscular · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-410-13 | 6745704101367457041013 | 10 VIAL in 1 CARTON (67457-410-13) / 1 mL in 1 VIAL (67457-410-00)Marketed from Apr 23, 2013 |
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)
- Haloperidol Decanoate
- Generic name (nonproprietary)
- haloperidol decanoate
- Active ingredients
- Haloperidol decanoate — 50 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075440
- Marketing start
- Listing expires
- Identifiers
- Product ID 67457-410_59ec8e4f-5adc-4342-add6-1357f5512cbdSPL ID 59ec8e4f-5adc-4342-add6-1357f5512cbdSPL set ID 8ffac6fb-1702-40d6-b085-152d24673cbdRxCUI 1719803, 1719862UNII AC20PJ4101
- Pharmacologic class
- Typical 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 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
N467457041013followed by a unit qualifier and the quantityPackage 67457-0410-13. 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)
Haloperidol decanoate injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product. Haloperidol decanoate injection is a typical antipsychotic indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 67457-410
- What is NDC 67457-410?
- 67457-410 is the product NDC for Haloperidol Decanoate, Haloperidol decanoate 50 mg/mL injection, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Haloperidol Decanoate.
- What is the active ingredient?
- Haloperidol decanoate.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Haloperidol Decanoate?
- 55 other product NDCs are listed under this name. See all Haloperidol Decanoate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Haloperidol Decanoate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Haloperidol Decanoate | Haloperidol decanoate 50 mg/mL | InjectionIntramuscular | REMEDYREPACK INC. | 70518-4670 | 70518-4670-00 |
| Haloperidol Decanoate | Haloperidol decanoate 50 mg/mL | InjectionIntramuscular | Armas Pharmaceuticals Inc. | 72485-520 | 72485-0520-10 |
| Haloperidol Decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | Armas Pharmaceuticals Inc. | 72485-521 | 72485-0521-10 |
| Haloperidol Decanoate | Haloperidol decanoate 500 mg/5mL | InjectionIntramuscular | Armas Pharmaceuticals Inc. | 72485-522 | 72485-0522-01 |
| Haloperidol Decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | REMEDYREPACK INC. | 70518-4584 | 70518-4584-00 |
| Haloperidol Decanoate | Haloperidol decanoate 50 mg/mL | InjectionIntramuscular | Somerset Therapeutics, LLC | 70069-866 | 70069-0866-10 |
| Haloperidol Decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | Somerset Therapeutics, LLC | 70069-867 | 70069-0867-05 |
| Haloperidol Decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | Somerset Therapeutics, LLC | 70069-868 | 70069-0868-01 |
| Haloperidol decanoate | Haloperidol decanoate 50 mg/mL | InjectionIntramuscular | BluePoint Laboratories | 68001-657 | 68001-0657-51 |
| Haloperidol decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | BluePoint Laboratories | 68001-658 | 68001-0658-4168001-0658-52 |
Other NDCs under ANDA 075440
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 |
|---|---|---|---|---|
| Haloperidol Decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | Mylan Institutional LLC | 67457-409 |