Prescription drug · ANDA
Prochlorperazine Maleate NDC 43063-742
Prochlorperazine maleate 10 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-742-06 | 43063074206 | 6 TABLET in 1 BOTTLE, PLASTIC (43063-742-06)Marketed from Feb 6, 2017 | |
| 43063-742-15 | 43063074215 | 15 TABLET in 1 BOTTLE, PLASTIC (43063-742-15)Marketed from Nov 8, 2018 |
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
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040268
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 43063-742_51b5e4a7-7f5b-2f6f-e063-6294a90a2c02SPL ID 51b5e4a7-7f5b-2f6f-e063-6294a90a2c02SPL set ID fc77a504-4642-47c1-b2e3-c5db11e5816dRxCUI 198365UNII I1T8O1JTL6UPC 0343063742150
- 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
N443063074206followed by a unit qualifier and the quantityPackage 43063-0742-06. 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 040268
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 | TabletOral | Sportpharm LLC | 85766-233 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | Sportpharm LLC | 85766-232 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0952 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Proficient Rx LP | 63187-251 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-096 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-113 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-115 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2262 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4342 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Direct_Rx | 72189-503 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | AvPAK | 50268-684 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | AvPAK | 50268-685 |
| Prochlorperazine | Prochlorperazine maleate 5 mg/1 | TabletOral | PharmPak, Inc. | 54348-989 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-330 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | Proficient Rx LP | 63187-502 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1620 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | QPharma, Inc. | 42708-103 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2839 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-271 |