Prescription drug · ANDA
Haloperidol NDC 0832-1550
Haloperidol 10 mg/1 · Tablet · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-1550-01 | 0083215500100832155001 | 100 BLISTER PACK in 1 CARTON (0832-1550-01) / 1 TABLET in 1 BLISTER PACK (0832-1550-89)Marketed from Sep 30, 2022 | |
| 0832-1550-11 | 0083215501100832155011 | 100 TABLET in 1 BOTTLE (0832-1550-11)Marketed from Jan 13, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Upsher-Smith Laboratories, LLCNDC labeler code 0832
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211061
- Marketing start
- Listing expires
- Identifiers
- Product ID 0832-1550_ca5f7ae2-4c1e-488e-8d6f-32c3a5bfe3fbSPL ID ca5f7ae2-4c1e-488e-8d6f-32c3a5bfe3fbSPL set ID afb3ac3e-7459-42d3-b5ca-e0d6d27ced73RxCUI 197754, 310670, 310671, 310672, 314034, 314035UNII 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
N400832155001followed by a unit qualifier and the quantityPackage 00832-1550-01. 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 0832-1550
- What is NDC 0832-1550?
- 0832-1550 is the product NDC for Haloperidol, Haloperidol 10 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 2 package NDCs, 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?
- Upsher-Smith Laboratories, LLC, NDC labeler code 0832. 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 211061
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 | Upsher-Smith Laboratories, LLC | 0832-1510 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1520 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1530 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1540 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1560 |