Prescription drug · ANDA
Haloperidol NDC 69292-582
Haloperidol 1 mg/1 · Tablet · Oral · Amici Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69292-582-01 | 6929205820169292058201 | 100 TABLET in 1 BOTTLE (69292-582-01)Marketed from Apr 18, 2022 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amici Pharmaceuticals, LLCNDC labeler code 69292
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071173
- Marketing start
- Listing expires
- Identifiers
- Product ID 69292-582_8c9cdd3d-9751-404a-9ceb-276e8dfa6391SPL ID 8c9cdd3d-9751-404a-9ceb-276e8dfa6391SPL set ID 9a9e20dd-646a-4fe9-a345-1b5bda8e7775RxCUI 197754, 310670, 310671, 310672, 314034, 314035UNII J6292F8L3DUPC 0369292586013, 0369292582015, 0369292590010, 0369292584019, 0369292588017, 0369292580011, 0369292586105
- 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
N469292058201followed by a unit qualifier and the quantityPackage 69292-0582-01. 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.
About NDC 69292-582
- What is NDC 69292-582?
- 69292-582 is the product NDC for Haloperidol, Haloperidol 1 mg/1 tablet, listed with the FDA by Amici Pharmaceuticals, LLC. 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?
- Amici Pharmaceuticals, LLC, NDC labeler code 69292. 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 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 .5 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-752 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-753 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-754 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-755 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-756 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-757 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-700 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-701 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-702 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-703 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-704 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-705 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-900 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-901 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-902 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-903 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-904 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-905 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2326 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9270 |
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