Prescription drug · ANDA
Haloperidol Decanoate NDC 68083-138
Haloperidol decanoate 100 mg/mL · Injection · Intramuscular · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-138-02 | 68083013802 | 1 VIAL in 1 CARTON (68083-138-02) / 5 mL in 1 VIALMarketed from Jan 16, 2017 | |
| 68083-138-10 | 68083013810 | 10 VIAL in 1 CARTON (68083-138-10) / 1 mL in 1 VIALMarketed from Jan 16, 2017 |
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 — 100 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205241
- Marketing start
- Listing expires
- Identifiers
- Product ID 68083-138_09213604-f576-4578-ad34-92b448e3c782SPL ID 09213604-f576-4578-ad34-92b448e3c782SPL set ID 1a0e38cb-fd9f-4962-9f81-5c0023ca6b4cRxCUI 859867, 859871, 1719803, 1719862UNII AC20PJ4101UPC 0368083137106, 0368083138103
- 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
N468083013802followed by a unit qualifier and the quantityPackage 68083-0138-02. 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
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205241
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 50 mg/mL | InjectionIntramuscular | Gland Pharma Limited | 68083-137 |
| haloperidol decanoate | Haloperidol decanoate 100 mg/mL | Injection, SolutionIntramuscular | Sagent Pharmaceuticals | 25021-833 |
| haloperidol decanoate | Haloperidol decanoate 50 mg/mL | Injection, SolutionIntramuscular | Sagent Pharmaceuticals | 25021-831 |
| haloperidol decanoate | Haloperidol decanoate 500 mg/5mL | Injection, SolutionIntramuscular | Sagent Pharmaceuticals | 25021-834 |