Prescription drug · ANDA
Haloperidol NDC 70518-1269
Haloperidol 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1269-0 | 70518126900 | 30 TABLET in 1 BLISTER PACK (70518-1269-0)Marketed from Jun 19, 2018 |
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 077580
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-1269_48c3d134-d4dd-a5fc-e063-6294a90acd5aSPL ID 48c3d134-d4dd-a5fc-e063-6294a90acd5aSPL set ID 58fa9328-b1c7-407c-b215-9887db90cb94RxCUI 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
N470518126900followed by a unit qualifier and the quantityPackage 70518-1269-00. 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 is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is 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, aggressivity, mood lability, and p…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077580
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 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6782 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Coupler LLC | 67046-1255 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-409 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Safecor Health, LLC | 48433-151 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-626 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Safecor Health, LLC | 48433-152 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-627 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-407 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Safecor Health, LLC | 48433-153 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-628 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-408 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | American Health Packaging | 68084-249 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | American Health Packaging | 68084-250 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Coupler LLC | 67046-0329 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3566 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-037 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-839 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Coupler LLC | 67046-1544 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-837 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6733 |
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