Prescription drug · ANDA
Prochlorperazine Maleate NDC 68462-947
Prochlorperazine maleate 10 mg/1 · Tablet · Oral · GLENMARK PHARMACEUTICALS INC., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-947-01 | 6846209470168462094701 | 100 TABLET in 1 BOTTLE (68462-947-01)Marketed from May 28, 2025 | |
| 68462-947-10 | 6846209471068462094710 | 1000 TABLET in 1 BOTTLE (68462-947-10)Marketed from May 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
- Route
- Oral
- Labeler
- GLENMARK PHARMACEUTICALS INC., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216595
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 68462-947_87ee1668-fd00-4e54-8c72-14ca91b94e0eSPL ID 87ee1668-fd00-4e54-8c72-14ca91b94e0eSPL set ID 9c806152-70d0-43eb-b183-b51b12b82b31RxCUI 198365, 312635UNII I1T8O1JTL6UPC 0368462947012
- 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
N468462094701followed by a unit qualifier and the quantityPackage 68462-0947-01. 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 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.
About NDC 68462-947
- What is NDC 68462-947?
- 68462-947 is the product NDC for Prochlorperazine Maleate, Prochlorperazine maleate 10 mg/1 tablet, listed with the FDA by GLENMARK PHARMACEUTICALS INC., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prochlorperazine Maleate.
- What is the active ingredient?
- Prochlorperazine maleate.
- Who is the labeler?
- GLENMARK PHARMACEUTICALS INC., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prochlorperazine Maleate?
- 61 other product NDCs are listed under this name. See all Prochlorperazine Maleate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prochlorperazine Maleate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| prochlorperazine maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4728 | 70518-4728-00 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4498 | 70518-4498-00 |
| prochlorperazine maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-773 | 59651-0773-01 |
| prochlorperazine maleate | Prochlorperazine maleate 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-774 | 59651-0774-01 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-517 | 72789-0517-0172789-0517-90 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-518 | 72789-0518-0172789-0518-1572789-0518-90 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | Leading Pharma, LLC | 69315-265 | 69315-0265-01 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | Tablet, Film coatedOral | Leading Pharma, LLC | 69315-266 | 69315-0266-01 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4319 | 70518-4319-00 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7634 | 50090-7634-05 |
Other NDCs under ANDA 216595
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 | GLENMARK PHARMACEUTICALS INC., USA | 68462-889 |