Prescription drug · ANDA
Haloperidol NDC 65841-837
Haloperidol .5 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-837-01 | 6584108370165841083701 | 100 TABLET in 1 BOTTLE (65841-837-01)Marketed from Feb 1, 2023 | |
| 65841-837-10 | 6584108371065841083710 | 1000 TABLET in 1 BOTTLE (65841-837-10)Marketed from Feb 1, 2023 | |
| 65841-837-77 | 6584108377765841083777 | 10 BLISTER PACK in 1 CARTON (65841-837-77) / 10 TABLET in 1 BLISTER PACK (65841-837-30)Marketed from Feb 1, 2023 |
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 — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 65841
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077580
- Marketing start
- Listing expires
- Identifiers
- Product ID 65841-837_2ff366f9-878f-4fcb-b2d4-00fb6e31ecbfSPL ID 2ff366f9-878f-4fcb-b2d4-00fb6e31ecbfSPL set ID 509d0eb2-b930-4836-9669-dbebf0ac4076RxCUI 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
N465841083701followed by a unit qualifier and the quantityPackage 65841-0837-01. 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 .
About NDC 65841-837
- What is NDC 65841-837?
- 65841-837 is the product NDC for Haloperidol, Haloperidol .5 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 3 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?
- Zydus Lifesciences Limited, NDC labeler code 65841. 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 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 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6661 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6733 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6782 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Safecor Health, LLC | 48433-151 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Safecor Health, LLC | 48433-152 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Safecor Health, LLC | 48433-153 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3566 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | American Health Packaging | 60687-161 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-626 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-627 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-628 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-838 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-839 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Coupler LLC | 67046-0329 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Coupler LLC | 67046-0838 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Coupler LLC | 67046-1255 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Coupler LLC | 67046-1544 |
| 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 | Zydus Pharmaceuticals USA Inc. | 68382-079 |
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