Prochlorperazine Edisylate
- Product NDC
- 70860-778
- 11-digit product format
- 708600778
- Labeler code
- 70860
- Product ID
- 70860-778_0a1bce3b-675f-420b-a8fd-a93bde270753
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prochlorperazine edisylate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Athenex Pharmaceutical Division, LLC.
- Application
- ANDA040540
- Marketing category
- ANDA
- Marketing start
- 2018-11-08
- Marketing end
- 0000-00-00
- Substance
- PROCHLORPERAZINE EDISYLATE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 70860-778 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 70860-778 | 70860-778-02 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A040540-001 | PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | AP | | 2004-05-28 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A040540-001 | AP |
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70860-778-02 | 70860077802 | 10 VIAL in 1 CARTON (70860-778-02) > 2 mL in 1 VIAL (70860-778-41) | 10 vial | 2018-11-08 | 0000-00-00 | No | No | Current |
| 70860-778-10 | 70860077810 | 1 VIAL, MULTI-DOSE in 1 CARTON (70860-778-10) > 10 mL in 1 VIAL, MULTI-DOSE | | 2018-11-08 | 0000-00-00 | No | No | Current |