Prescription drug · ANDA
Haloperidol NDC 0904-7504
Haloperidol 2 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7504-61 | 0090475046100904750461 | 100 BLISTER PACK in 1 CARTON (0904-7504-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 28, 2025 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216918
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-7504_8a1014d0-d917-40b7-bddd-9ac97df91ef4SPL ID 8a1014d0-d917-40b7-bddd-9ac97df91ef4SPL set ID 8a1014d0-d917-40b7-bddd-9ac97df91ef4RxCUI 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
N400904750461followed by a unit qualifier and the quantityPackage 00904-7504-61. 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.
About NDC 0904-7504
- What is NDC 0904-7504?
- 0904-7504 is the product NDC for Haloperidol, Haloperidol 2 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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 216918
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 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4725 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8626 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8627 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-001 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4285 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-002 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-003 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-004 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-236 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-242 |