Desvenlafaxine
- Product NDC
- 0378-4230
- 11-digit product format
- 003784230
- Labeler code
- 0378
- Product ID
- 0378-4230_28b790a8-f6d5-4dd1-8246-8c146d0c7207
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- desvenlafaxine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA204095
- Marketing category
- ANDA
- Marketing start
- 2017-03-01
- Marketing end
- 2020-01-31
- Substance
- DESVENLAFAXINE SUCCINATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 0378-4230 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0378-4230 | 0378-4230-77 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0378-4230 | 0378-4230-93 | 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 |
|---|
| A204095-001 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | | | 2015-06-29 |
| A204095-002 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | | | 2015-06-29 |
DailyMed Product Concepts#
DailyMed RxNorm Mappings#