Prescription drug · ANDA
Haloperidol NDC 67046-1603
Haloperidol 5 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1603-3 | 67046160303 | 30 TABLET in 1 BLISTER PACK (67046-1603-3)Marketed from Oct 1, 2025 |
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
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218789
- Marketing start
- Listing expires
- Identifiers
- Product ID 67046-1603_40187e11-e94a-e759-e063-6394a90a4840SPL ID 40187e11-e94a-e759-e063-6394a90a4840SPL set ID 40187e83-1144-db0e-e063-6394a90a42dfRxCUI 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
N467046160303followed by a unit qualifier and the quantityPackage 67046-1603-03. 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 218789
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 20 mg/1 | TabletOral | Coupler LLC | 67046-1673 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-789 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-791 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-790 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-792 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-793 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-794 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Coupler LLC | 67046-1498 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Coupler LLC | 67046-1548 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2937 |