Prescription drug · ANDA
Desvenlafaxine Succinate NDC 68180-604
Desvenlafaxine succinate 25 mg/1 · Tablet, Film coated, Extended release · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-604-06 | 68180060406 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-604-06)Marketed from Aug 25, 2022 |
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 — 25 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204172
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68180-604_748a4941-405f-436f-933b-0bec4b119e3cSPL ID 748a4941-405f-436f-933b-0bec4b119e3cSPL set ID e96272a2-8f73-4fbe-a8d4-a78d4ad68831RxCUI 1607617, 1874553, 1874559UNII ZB22ENF0XRUPC 0368180593065, 0368180592068, 0368180604068
- 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
N468180060406followed by a unit qualifier and the quantityPackage 68180-0604-06. 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 tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES ( 14 )]. Desvenlafaxine extended-release tablet, 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 204172
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 50 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-592 |
| Desvenlafaxine Succinate | Desvenlafaxine succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-593 |
| Desvenlafaxine Succinate | Desvenlafaxine succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8556 |
| Desvenlafaxine Succinate | Desvenlafaxine succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-7468 |
| Desvenlafaxine Succinate | Desvenlafaxine succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2494 |
| Desvenlafaxine Succinate | Desvenlafaxine succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1150 |
| Desvenlafaxine ER | Desvenlafaxine succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_Rx | 61919-882 |
| Desvenlafaxine Succinate | Desvenlafaxine succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-6894 |
| Desvenlafaxine Succinate | Desvenlafaxine succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1331 |