Prescription drug · ANDA
Prochlorperazine Maleate NDC 72789-518
Prochlorperazine maleate 10 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-518-01 | 72789051801 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-01)Marketed from Jul 28, 2025 | |
| 72789-518-15 | 72789051815 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-15)Marketed from Dec 15, 2025 | |
| 72789-518-90 | 72789051890 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-90)Marketed from Jul 28, 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
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218912
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 72789-518_4603a67f-05af-5931-e063-6394a90afcf3SPL ID 4603a67f-05af-5931-e063-6394a90afcf3SPL set ID 3b022837-0fcc-d38a-e063-6394a90a0f7fRxCUI 198365, 312635UNII I1T8O1JTL6UPC 0372789517902
- 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
N472789051801followed by a unit qualifier and the quantityPackage 72789-0518-01. 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 218912
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 10 mg/1 | Tablet, Film coatedOral | Leading Pharma, LLC | 69315-266 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-517 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | Leading Pharma, LLC | 69315-265 |