Prescription drug · ANDA
Haloperidol (haloperidol lactate) NDC 70518-0035
Haloperidol lactate 5 mg/mL · Injection, Solution · Intramuscular · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-0035-0 | 70518003500 | 25 VIAL in 1 TRAY (70518-0035-0) / 1 mL in 1 VIALMarketed from Dec 2, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- haloperidol lactate
- Active ingredients
- Haloperidol lactate — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075689
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-0035_4cd54384-6fbc-ee88-e063-6294a90aa4efSPL ID 4cd54384-6fbc-ee88-e063-6294a90aa4efSPL set ID e702b2f0-d464-41c3-977a-d37bb22c0ab0RxCUI 1719646UNII 6387S86PK3
- 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
N470518003500followed by a unit qualifier and the quantityPackage 70518-0035-00. 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 AND USAGE Haloperidol injection is indicated for the treatment of patients with schizophrenia.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075689
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 |
|---|---|---|---|---|
| Haloperidolhaloperidol lactate | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | HF Acquisition Co LLC, DBA HealthFirst | 51662-1524 |
| Haloperidolhaloperidol lactate | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | Cardinal Health 107, LLC | 55154-9553 |
| Haloperidolhaloperidol lactate | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | Fresenius Kabi USA, LLC | 63323-474 |