Prescription drug · ANDA
prochlorperazine maleate NDC 59651-774
Prochlorperazine maleate 10 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-774-01 | 59651077401 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-774-01)Marketed from Sep 8, 2025 |
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)
- prochlorperazine maleate
- Generic name (nonproprietary)
- prochlorperazine maleate
- Active ingredients
- Prochlorperazine maleate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218734
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 59651-774_7ec4df20-9ea5-4a68-a43f-5ded4eaed235SPL ID 7ec4df20-9ea5-4a68-a43f-5ded4eaed235SPL set ID 7ec4df20-9ea5-4a68-a43f-5ded4eaed235RxCUI 198365, 312635UNII I1T8O1JTL6
- Pharmacologic class
- Phenothiazine
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
N459651077401followed by a unit qualifier and the quantityPackage 59651-0774-01. 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 For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218734
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 |
|---|---|---|---|---|
| prochlorperazine maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4728 |
| prochlorperazine maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-773 |