Prescription drug · ANDA
Haloperidol NDC 0904-6661
Haloperidol 20 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6661-04 | 00904666104 | 30 BLISTER PACK in 1 CARTON (0904-6661-04) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 3, 2008 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077580
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-6661_417d8c81-c958-430f-8a84-75c69b8676ccSPL ID 417d8c81-c958-430f-8a84-75c69b8676ccSPL set ID e07f02d4-2768-4978-97ee-23ac52d0b846RxCUI 197754, 310672, 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
N400904666104followed by a unit qualifier and the quantityPackage 00904-6661-04. 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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