Prescription drug · ANDA
Prochlorperazine Maleate NDC 70518-4200
Prochlorperazine maleate 10 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4200-0 | 70518420000 | 10 TABLET in 1 BOTTLE, PLASTIC (70518-4200-0)Marketed from Oct 2, 2024 |
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)
- Prochlorperazine Maleate
- Generic name (nonproprietary)
- prochlorperazine maleate
- Active ingredients
- Prochlorperazine maleate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216495
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 70518-4200_5a585784-dab7-39d5-e063-6294a90a530aSPL ID 5a585784-dab7-39d5-e063-6294a90a530aSPL set ID 5c1dd0ea-89e9-4317-a83e-5e15da79ca20RxCUI 198365UNII 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
N470518420000followed by a unit qualifier and the quantityPackage 70518-4200-00. 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 For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is 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 should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216495
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 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1667 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1668 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-044 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1697 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1698 |