Prescription drug · ANDA
Desvenlafaxine NDC 0591-3660
Desvenlafaxine succinate 100 mg/1 · Tablet, Extended release · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-3660-30 | 00591366030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-3660-30)Marketed from Mar 1, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Desvenlafaxine
- Generic name (nonproprietary)
- desvenlafaxine
- Active ingredients
- Desvenlafaxine succinate — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204065
- Marketing start
- Marketing end
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0591-3660_f5e72c18-96f8-4538-a238-8c72138bd6ceSPL ID f5e72c18-96f8-4538-a238-8c72138bd6ceSPL set ID 617476f9-62d7-40ef-a1b1-c349d4ad706fRxCUI 1607617, 1874553, 1874559UNII ZB22ENF0XR
- Pharmacologic class
- Serotonin and Norepinephrine Reuptake Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400591366030followed by a unit qualifier and the quantityPackage 00591-3660-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Desvenlafaxine extended-release tablets are indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14 )] . Desvenlafaxine extended-release tablets are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204065
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Actavis Pharma, Inc. | 0591-3659 |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | Actavis Pharma, Inc. | 0591-4060 |