Prescription drug · ANDA
Haloperidol NDC 48433-152
Haloperidol 1 mg/1 · Tablet · Oral · Safecor Health, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-152-20 | 4843301522048433015220 | 100 BLISTER PACK in 1 CARTON (48433-152-20) / 1 TABLET in 1 BLISTER PACK (48433-152-01)Marketed from Jun 1, 2026 |
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
- Generic name (nonproprietary)
- haloperidol
- Active ingredients
- Haloperidol — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Safecor Health, LLCNDC labeler code 48433
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077580
- Marketing start
- Listing expires
- Identifiers
- Product ID 48433-152_53ff97f3-62e9-0b53-e063-6294a90ae539SPL ID 53ff97f3-62e9-0b53-e063-6294a90ae539SPL set ID 9be08519-b3b5-4b9d-ae4c-bb7e68f19edeRxCUI 310670, 310671, 314034UNII 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
N448433015220followed by a unit qualifier and the quantityPackage 48433-0152-20. 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.
About NDC 48433-152
- What is NDC 48433-152?
- 48433-152 is the product NDC for Haloperidol, Haloperidol 1 mg/1 tablet, listed with the FDA by Safecor Health, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Haloperidol.
- What is the active ingredient?
- Haloperidol.
- Who is the labeler?
- Safecor Health, LLC, NDC labeler code 48433. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Haloperidol?
- 170 other product NDCs are listed under this name. See all Haloperidol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Haloperidol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-264 | 27241-0264-01 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-265 | 27241-0265-01 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-266 | 27241-0266-01 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-267 | 27241-0267-01 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-268 | 27241-0268-01 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-269 | 27241-0269-01 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4725 | 70518-4725-00 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Coupler LLC | 67046-0329 | 67046-0329-03 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-037 | 87441-0037-01 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Safecor Health, LLC | 48433-151 | 48433-0151-20 |
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 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6661 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6733 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6782 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Safecor Health, LLC | 48433-151 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Safecor Health, LLC | 48433-153 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3566 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | American Health Packaging | 60687-161 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-626 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-627 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-628 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-837 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-838 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-839 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Coupler LLC | 67046-0329 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Coupler LLC | 67046-0838 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Coupler LLC | 67046-1255 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Coupler LLC | 67046-1544 |
| 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 | Zydus Pharmaceuticals USA Inc. | 68382-079 |
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