Prescription drug · ANDA
Pimozide NDC 49884-348
Pimozide 2 mg/1 · Tablet · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-348-01 | 49884034801 | 100 TABLET in 1 BOTTLE (49884-348-01)Marketed from Sep 28, 2015 |
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)
- Pimozide
- Generic name (nonproprietary)
- pimozide
- Active ingredients
- Pimozide — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204521
- Marketing start
- Listing expires
- Identifiers
- Product ID 49884-348_a3c5958c-a773-4d10-ae80-9cd453bf07feSPL ID a3c5958c-a773-4d10-ae80-9cd453bf07feSPL set ID 70b079e2-a1f7-4a93-8685-d60a4d7c1280RxCUI 198103, 312439UNII 1HIZ4DL86FUPC 0349884347017, 0349884348014
- 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
N449884034801followed by a unit qualifier and the quantityPackage 49884-0348-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Pimozide tablets, USP are indicated for the suppression of motor and phonic tics in patients with Tourette’s Disorder who have failed to respond satisfactorily to standard treatment. Pimozide tablets, USP are not intended as a treatment of first choice nor is it intended for the treatment of tics that are merely annoying or cosmetically troublesome. Pimozide tablets, USP should be reserved for use in Tourette’s Disorder patients whose development and/or daily life function is severely compromised by the presence of motor and phonic tics. Evidence supporting approval of pimozide tablets, USP for use in Tourette’s Disorder was obtained in two controlled clinical investiga…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204521
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 |
|---|---|---|---|---|
| Pimozide | Pimozide 1 mg/1 | TabletOral | Par Health USA, LLC | 49884-347 |