Prescription drug · ANDA
Desvenlafaxine Succinate NDC 33342-388
Desvenlafaxine succinate 50 mg/1 · Tablet, Extended release · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-388-07 | 33342038807 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-388-07)Marketed from Jul 30, 2020 | |
| 33342-388-10 | 33342038810 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-388-10)Marketed from Jul 30, 2020 | |
| 33342-388-12 | 33342038812 | 10 BLISTER PACK in 1 CARTON (33342-388-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 30, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 Succinate
- Generic name (nonproprietary)
- desvenlafaxine succinate
- Active ingredients
- Desvenlafaxine succinate — 50 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211427
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-388_edf18b33-a226-44f8-9f42-c409e691ee64SPL ID edf18b33-a226-44f8-9f42-c409e691ee64SPL set ID edf18b33-a226-44f8-9f42-c409e691ee64RxCUI 1874553, 1874559UNII ZB22ENF0XRUPC 0333342389121, 0333342388100, 0333342389107, 0333342388070, 0333342388124, 0333342389077
- 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
N433342038807followed by a unit qualifier and the quantityPackage 33342-0388-07. 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 is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14 )]. Desvenlafaxine is 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 211427
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 Succinate | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-389 |