Prescription drug · ANDA
Haloperidol NDC 58657-905
Haloperidol 20 mg/1 · Tablet · Oral · Method Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-905-01 | 58657090501 | 100 TABLET in 1 CARTON (58657-905-01)Marketed from Jun 5, 2025 | |
| 58657-905-03 | 58657090503 | 30 TABLET in 1 CARTON (58657-905-03)Marketed from Jun 5, 2025 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Method Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071173
- Marketing start
- Listing expires
- Identifiers
- Product ID 58657-905_38c21c0c-f6b3-adda-e063-6294a90a0ffdSPL ID 38c21c0c-f6b3-adda-e063-6294a90a0ffdSPL set ID 87f8773b-bf89-4f7e-bff4-8cad117d5776RxCUI 197754, 310670, 310671, 310672, 314034, 314035UNII J6292F8L3DUPC 0358657701109, 0358657702106, 0358657704018, 0358657700010, 0358657703011, 0358657702014, 0358657705015, 0358657700102, 0358657705107, 0358657905033, 0358657704100, 0358657701017, 0358657703103
- 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
N458657090501followed by a unit qualifier and the quantityPackage 58657-0905-01. 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, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP 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, USP 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071173
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 1 mg/1 | TabletOral | Amici Pharmaceuticals, LLC | 69292-582 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Amici Pharmaceuticals, LLC | 69292-580 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Amici Pharmaceuticals, LLC | 69292-588 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Amici Pharmaceuticals, LLC | 69292-584 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Amici Pharmaceuticals, LLC | 69292-586 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3608 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Amici Pharmaceuticals, LLC | 69292-590 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1684 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1683 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1688 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1685 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1686 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1687 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Coupler LLC | 67046-0053 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3021 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2882 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2880 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Innogenix, Inc. | 71247-151 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Innogenix, Inc. | 71247-150 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Innogenix, Inc. | 71247-154 |
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