Prescription drug · ANDA
Prochlorperazine Maleate NDC 69452-472
Prochlorperazine maleate 10 mg/1 · Tablet · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-472-20 | 6945204722069452047220 | 100 TABLET in 1 BOTTLE (69452-472-20)Marketed from Jan 31, 2025 | |
| 69452-472-32 | 6945204723269452047232 | 1000 TABLET in 1 BOTTLE (69452-472-32)Marketed from Jan 31, 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
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217478
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 69452-472_2cf363d6-b9e5-2c22-e063-6394a90a7649SPL ID 2cf363d6-b9e5-2c22-e063-6394a90a7649SPL set ID 2cf363d6-b9e4-2c22-e063-6394a90a7649RxCUI 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
N469452047220followed by a unit qualifier and the quantityPackage 69452-0472-20. 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 h…
Excerpt only. Read the full label for complete information.
About NDC 69452-472
- What is NDC 69452-472?
- 69452-472 is the product NDC for Prochlorperazine Maleate, Prochlorperazine maleate 10 mg/1 tablet, listed with the FDA by Bionpharma Inc.. 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?
- Bionpharma Inc., NDC labeler code 69452. 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 | GLENMARK PHARMACEUTICALS INC., USA | 68462-947 | 68462-0947-0168462-0947-10 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4319 | 70518-4319-00 |
Other NDCs under ANDA 217478
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 | Bionpharma Inc. | 69452-471 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2099 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7147 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4498 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2621 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | Redpharm Drug | 67296-2178 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | TabletOral | Redpharm Drug | 67296-2195 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2386 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-309 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-310 |
| Prochlorperazine Maleate | Prochlorperazine maleate 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8708 |
| Prochlorperazine Maleate | Prochlorperazine maleate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7634 |