Prescription drug · ANDA
Haloperidol NDC 70518-4285
Haloperidol 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4285-0 | 70518428500 | 30 TABLET in 1 BLISTER PACK (70518-4285-0)Marketed from Feb 11, 2025 | |
| 70518-4285-1 | 70518428501 | 100 POUCH in 1 BOX (70518-4285-1) / 1 TABLET in 1 POUCH (70518-4285-2)Marketed from Aug 31, 2026 |
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
- Active ingredients
- Haloperidol — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216918
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4285_5a5a5e13-73d5-e3f0-e063-6394a90a07c5SPL ID 5a5a5e13-73d5-e3f0-e063-6394a90a07c5SPL set ID a0751f2e-05ab-4ba9-9bae-7b791bf1a621RxCUI 310672UNII J6292F8L3D
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470518428500followed by a unit qualifier and the quantityPackage 70518-4285-00. 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 tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216918
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 | Haloperidol 1 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-002 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-001 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-003 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-004 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4725 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8626 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8627 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-236 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-242 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7504 |