Prescription drug · ANDA
Haloperidol NDC 70518-1182
Haloperidol 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1182-0 | 7051811820070518118200 | 30 TABLET in 1 BLISTER PACK (70518-1182-0)Marketed from May 14, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077580
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-1182_48c04dcd-77d9-3721-e063-6294a90ac815SPL ID 48c04dcd-77d9-3721-e063-6294a90ac815SPL set ID 1e396020-899d-4f51-b71a-4982c503ca4fRxCUI 310672UNII 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
N470518118200followed by a unit qualifier and the quantityPackage 70518-1182-00. 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.
About NDC 70518-1182
- What is NDC 70518-1182?
- 70518-1182 is the product NDC for Haloperidol, Haloperidol 5 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 .5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-837 |
| 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 |
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