Prochlorperazine Edisylate
- Product NDC
- 0641-6135
- 11-digit product format
- 006416135
- Labeler code
- 0641
- Product ID
- 0641-6135_6ffbbb71-5711-43b7-beb5-5ccfb6128cb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prochlorperazine Edisylate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA089903
- Marketing category
- ANDA
- Marketing start
- 1989-08-29
- Substance
- PROCHLORPERAZINE EDISYLATE
- Active strength
- 5 mg/mL
- 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 Edisylate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROCHLORPERAZINE EDISYLATE | 5 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | PG20W5VQZS |
| Rxcui | 314192 |
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 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| a6ffe0a0-7823-b305-75e9-2a5c6f2be4ac | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-6135-01 | Prochlorperazine Edisylate | 2 mL in 1 VIAL | INJECTION | 2 | 7 | |
| 0641-6135-25 | Prochlorperazine Edisylate | 25 in 1 CARTON | INJECTION | 25 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6135-01 | ML - Milliliter | 0641-6135 | c57f245a-6b8b-4af3-8c94-37178969094f | 1 | 2016-11-08 |
| 0641-6135-25 | ML - Milliliter | 0641-6135 | 64870d1d-901a-4468-98a4-a95dc6523b8e | 1 | 2016-11-08 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PROCHLORPERAZINE EDISYLATE | ACTIVE INGREDIENT | PG20W5VQZS | PROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.] | 2 | |
| PROCHLORPERAZINE | ACTIVE MOIETY | YHP6YLT61T | PROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.] | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | PROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.] | 2 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | PROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.] | 2 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | PROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.] | 2 | |
| SODIUM TARTRATE DIHYDRATE | INACTIVE INGREDIENT | DIA7C37AOW | PROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314192 | prochlorperazine 10 MG in 2 ML Injection | PSN | baf59816-7577-4652-b065-fb6de9e54569 | 7 |
| 314192 | 2 ML prochlorperazine 5 MG/ML Injection | SCD | baf59816-7577-4652-b065-fb6de9e54569 | 7 |
| 314192 | prochlorperazine 10 MG (as prochlorperazine edisylate) per 2 ML Injection | SY | baf59816-7577-4652-b065-fb6de9e54569 | 7 |
| 314192 | prochlorperazine 10 MG per 2 ML Injection | SY | baf59816-7577-4652-b065-fb6de9e54569 | 7 |
| 2102949 | prochlorperazine 5 MG/ML Injectable Solution | PSN | e181c18d-32a8-587e-e053-2995a90acc5b | 2 |
| 2102949 | prochlorperazine 5 MG/ML Injectable Solution | SCD | e181c18d-32a8-587e-e053-2995a90acc5b | 2 |
| 2102949 | prochlorperazine (as edisylate) 5 MG/ML Injectable Solution | SY | e181c18d-32a8-587e-e053-2995a90acc5b | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0641-6135-01 | 00641613501 | 2 mL in 1 VIAL | 2 ml | Historical | ||||
| 0641-6135-25 | 00641613525 | 25 VIAL in 1 CARTON (0641-6135-25) / 2 mL in 1 VIAL (0641-6135-01) | 25 vial | 1989-08-29 | 0000-00-00 | No | No | Current |