Prochlorperazine Edisylate
- Product NDC
- 0713-0351
- 11-digit product format
- 007130351
- Labeler code
- 0713
- Product ID
- 0713-0351_284f182c-9dde-805f-e063-6394a90a0f02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prochlorperazine Edisylate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA213626
- Marketing category
- ANDA
- Marketing start
- 2022-02-11
- 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 table| Ingredient | Strength |
|---|
| PROCHLORPERAZINE EDISYLATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PG20W5VQZS |
| Rxcui | 2102949 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0351-02 | Prochlorperazine Edisylate | 2 mL in 1 VIAL | INJECTION | 2 | | 3 |
| 0713-0351-09 | Prochlorperazine Edisylate | 10 in 1 PACKAGE | INJECTION | 10 | | 3 |
| 0713-0351-25 | Prochlorperazine Edisylate | 25 in 1 PACKAGE | INJECTION | 25 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0351 | PROCHLORPERAZINE EDISYLATE INJECTION [COSETTE PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20241204_4687b9f5-2d67-4fe0-af4d-2415a42b5292.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0713-0351-02 | 00713035102 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 0713-0351-09 | 00713035109 | 10 VIAL in 1 PACKAGE (0713-0351-09) / 2 mL in 1 VIAL (0713-0351-02) | 10 vial | 2022-02-11 | 0000-00-00 | No | No | Current |
| 0713-0351-25 | 00713035125 | 25 VIAL in 1 PACKAGE (0713-0351-25) / 2 mL in 1 VIAL (0713-0351-02) | 25 vial | 2022-02-11 | 0000-00-00 | No | No | Current |