Prescription drug · ANDA
Haloperidol NDC 82619-109
Haloperidol 10 mg/1 · Tablet · Oral · Creekwood Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82619-109-01 | 82619010901 | 30 TABLET in 1 BOTTLE (82619-109-01)Marketed from Jan 5, 2026 | |
| 82619-109-02 | 82619010902 | 100 TABLET in 1 BOTTLE (82619-109-02)Marketed from Jan 5, 2026 | |
| 82619-109-03 | 82619010903 | 1000 TABLET in 1 BOTTLE (82619-109-03)Marketed from Jan 5, 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218162
- Marketing start
- Listing expires
- Identifiers
- Product ID 82619-109_46d58435-0437-e206-e063-6294a90ae755SPL ID 46d58435-0437-e206-e063-6294a90ae755SPL set ID 9763c044-7430-48f7-bf3e-da1c7c683955RxCUI 197754, 310670, 310671, 310672, 314034, 314035UNII J6292F8L3DUPC 0382619105018, 0382619105025, 0382619108033, 0382619109023, 0382619109016, 0382619109030, 0382619110029, 0382619106022, 0382619107029, 0382619106015, 0382619107012, 0382619108026
- 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
N482619010901followed by a unit qualifier and the quantityPackage 82619-0109-01. 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 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 218162
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 | Bryant Ranch Prepack | 72162-2621 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2624 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2622 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2623 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2625 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2626 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-106 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-105 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-108 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-107 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-110 |