prochlorperazine maleate
- Product NDC
- 70518-4728
- Requested package NDC
- 70518-4728-0
- 11-digit product format
- 705184728
- Labeler code
- 70518
- Product ID
- 70518-4728_5965d9e3-b649-4050-e063-6294a90abea5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prochlorperazine maleate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA218734
- Marketing category
- ANDA
- Marketing start
- 2026-08-19
- Substance
- PROCHLORPERAZINE MALEATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218734-001 | PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-09-08 | |
| A218734-002 | PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-09-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218734-001 | AB |
| A218734-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218734-001 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-09-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218734-002 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-09-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A218734-001 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-09-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218734-002 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-09-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218734-001 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-09-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218734-002 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-09-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218734-001 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-09-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218734-002 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-09-08 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218734-001 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-09-08 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218734-002 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-09-08 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218734-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218734-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A218734-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218734-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218734-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218734-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218734-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218734-002 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218734-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218734-002 | AB | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- prochlorperazine maleate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROCHLORPERAZINE MALEATE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| I1T8O1JTL6 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312635 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b3c1d53b-702a-4980-973f-7f2e3affea70 | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| prochlorperazine maleate | PROCHLORPERAZINE MALEATE | REMEDYREPACK INC. | b3c1d53b-702a-4980-973f-7f2e3affea70 | 2026-08-19 | Boxed warning, Warnings, Adverse reactions | 218734 ANDA218734 70518-4728-0 70518-4728 70518472800 |
| prochlorperazine maleate | PROCHLORPERAZINE MALEATE | Aurobindo Pharma Limited | 7ec4df20-9ea5-4a68-a43f-5ded4eaed235 | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | 218734 ANDA218734 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 70518-4728-0 | 70518472800 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4728-0) | 2026-08-19 | No | No | Current |