PROCHLORPERAZINE MALEATE
- Product NDC
- 69315-265
- 11-digit product format
- 693150265
- Labeler code
- 69315
- Product ID
- 69315-265_e9585ce8-2433-4d85-ab3a-c544d7cb1532
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROCHLORPERAZINE MALEATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA218912
- Marketing category
- ANDA
- Marketing start
- 2025-06-25
- Substance
- PROCHLORPERAZINE MALEATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROCHLORPERAZINE MALEATE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROCHLORPERAZINE MALEATE | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | I1T8O1JTL6 |
| Rxcui | 198365, 312635 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9bfe4595-32b8-9175-3af8-875e9c4c0538 | Product name | 6 | 20260305 |
| 7335ddeb-6cbd-135c-487d-96fa4587ad65 | Product name | 6 | 20250331 |
| a6ffe0a0-7823-b305-75e9-2a5c6f2be4ac | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69315-265-01 | PROCHLORPERAZINE MALEATE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69315-265-01 | EA - Each | 69315-265 | 697a65b1-4a7b-4369-9e24-974bf00675eb | 1 | 2025-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198365 | prochlorperazine maleate 10 MG Oral Tablet | PSN | 3b022837-0fcc-d38a-e063-6394a90a0f7f | 5 |
| 312635 | prochlorperazine maleate 5 MG Oral Tablet | PSN | 3b022837-0fcc-d38a-e063-6394a90a0f7f | 5 |
| 198365 | prochlorperazine 10 MG Oral Tablet | SCD | 3b022837-0fcc-d38a-e063-6394a90a0f7f | 5 |
| 312635 | prochlorperazine 5 MG Oral Tablet | SCD | 3b022837-0fcc-d38a-e063-6394a90a0f7f | 5 |
| 198365 | prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet | SY | 3b022837-0fcc-d38a-e063-6394a90a0f7f | 5 |
| 312635 | prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet | SY | 3b022837-0fcc-d38a-e063-6394a90a0f7f | 5 |
| 198365 | prochlorperazine maleate 10 MG Oral Tablet | PSN | c93494ef-c510-4e46-a1b1-362624200223 | 2 |
| 312635 | prochlorperazine maleate 5 MG Oral Tablet | PSN | c93494ef-c510-4e46-a1b1-362624200223 | 2 |
| 198365 | prochlorperazine 10 MG Oral Tablet | SCD | c93494ef-c510-4e46-a1b1-362624200223 | 2 |
| 312635 | prochlorperazine 5 MG Oral Tablet | SCD | c93494ef-c510-4e46-a1b1-362624200223 | 2 |
| 198365 | prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet | SY | c93494ef-c510-4e46-a1b1-362624200223 | 2 |
| 312635 | prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet | SY | c93494ef-c510-4e46-a1b1-362624200223 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 69315-265-01 | 69315026501 | 100 TABLET, FILM COATED in 1 BOTTLE (69315-265-01) | 2025-06-25 | No | No | Current |