Prescription drug · ANDA
Haloperidol Decanoate NDC 65145-169
Haloperidol decanoate 100 mg/mL · Injection · Intramuscular · Caplin Steriles Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65145-169-01 | 65145016901 | 1 VIAL, MULTI-DOSE in 1 CARTON (65145-169-01) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from May 26, 2025 |
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
- Caplin Steriles Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219168
- Marketing start
- Listing expires
- Identifiers
- Product ID 65145-169_4f9af14a-38c4-4826-aca0-3501edb854e3SPL ID 4f9af14a-38c4-4826-aca0-3501edb854e3SPL set ID 4f9af14a-38c4-4826-aca0-3501edb854e3RxCUI 859871, 1719803, 1719862UNII AC20PJ4101UPC 0365145168108, 0365145167019, 0365145167101, 0365145169013, 0365145168016
- 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
N465145016901followed by a unit qualifier and the quantityPackage 65145-0169-01. 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)
INDICATIONS & USAGE Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219168
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 500 mg/5mL | InjectionIntramuscular | Armas Pharmaceuticals Inc. | 72485-522 |
| Haloperidol Decanoate | Haloperidol decanoate 50 mg/mL | InjectionIntramuscular | Armas Pharmaceuticals Inc. | 72485-520 |
| Haloperidol Decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | Armas Pharmaceuticals Inc. | 72485-521 |
| Haloperidol Decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | Caplin Steriles Limited | 65145-167 |
| Haloperidol Decanoate | Haloperidol decanoate 50 mg/mL | InjectionIntramuscular | Caplin Steriles Limited | 65145-168 |
| Haloperidol Decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | Somerset Therapeutics, LLC | 70069-867 |
| Haloperidol Decanoate | Haloperidol decanoate 50 mg/mL | InjectionIntramuscular | Somerset Therapeutics, LLC | 70069-866 |
| Haloperidol Decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | Somerset Therapeutics, LLC | 70069-868 |
| Haloperidol Decanoate | Haloperidol decanoate 100 mg/mL | InjectionIntramuscular | REMEDYREPACK INC. | 70518-4584 |