prochlorperazine edisylate
- Product NDC
- 83634-778
- 11-digit product format
- 836340778
- Labeler code
- 83634
- Product ID
- 83634-778_d8b06d8a-15cf-4aaa-933b-76bf2b4b035a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prochlorperazine edisylate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Avenacy Inc.
- Application
- ANDA204147
- Marketing category
- ANDA
- Marketing start
- 2024-06-01
- 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 |
|---|
| 83634-778-02 | prochlorperazine edisylate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
| 83634-778-41 | prochlorperazine edisylate | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83634-778 | PROCHLORPERAZINE EDISYLATE INJECTION, SOLUTION [AVENACY INC.] | 3 | Current NDC, 2 package rows | 20241215_fd07a1a3-c0df-4926-9964-07348e45a5fd.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 |
|---|
| 83634-778-02 | 83634077802 | 10 VIAL in 1 CARTON (83634-778-02) / 2 mL in 1 VIAL (83634-778-41) | 10 vial | 2024-06-01 | No | No | Current |
| 83634-778-41 | 83634077841 | 2 mL in 1 VIAL | 2 ml | | | | Historical |