Prochlorperazine Edisylate
- Product NDC
- 70069-371
- 11-digit product format
- 700690371
- Labeler code
- 70069
- Product ID
- 70069-371_2d2a447e-bfc4-42dc-b581-31c224ad24b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prochlorperazine Edisylate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA212257
- Marketing category
- ANDA
- Marketing start
- 2024-10-10
- 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 |
|---|
| 70069-371-01 | Prochlorperazine Edisylate | 2 mL in 1 VIAL | INJECTION | 2 | | 5 |
| 70069-371-25 | Prochlorperazine Edisylate | 25 in 1 CARTON | INJECTION | 25 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-371 | PROCHLORPERAZINE EDISYLATE INJECTION [SOMERSET THERAPEUTICS, LLC] | 5 | Current NDC, 2 package rows | 20241018_d382e3d4-3175-42f2-b9eb-d9a7b97cbbfc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70069-371-01 | 70069037101 | 2 mL in 1 VIAL | 2 ml | | | | Historical |
| 70069-371-25 | 70069037125 | 25 VIAL in 1 CARTON (70069-371-25) / 2 mL in 1 VIAL (70069-371-01) | 25 vial | 2024-10-10 | No | No | Current |