Prochlorperazine Edisylate
- Product NDC
- 68083-436
- 11-digit product format
- 680830436
- Labeler code
- 68083
- Product ID
- 68083-436_868ffb82-fd9b-4157-9e2c-1b76191ac1aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prochlorperazine Edisylate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA214107
- Marketing category
- ANDA
- Marketing start
- 2021-09-22
- 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 |
|---|
| 68083-436-01 | Prochlorperazine Edisylate | 10 mL in 1 VIAL | INJECTION | 10 | | 6 |
| 68083-436-01 | Prochlorperazine Edisylate | 1 in 1 CARTON | INJECTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-436 | PROCHLORPERAZINE EDISYLATE INJECTION [GLAND PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241215_a0fd3d58-7470-4d0f-9e6c-84e92c02a97f.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 |
|---|
| 68083-436-01 | 68083043601 | 1 VIAL in 1 CARTON (68083-436-01) / 10 mL in 1 VIAL | 1 vial | 2021-09-22 | 0000-00-00 | No | No | Current |