Prescription drug · ANDA
Desvenlafaxine Succinate NDC 68788-8556
Desvenlafaxine succinate 100 mg/1 · Tablet, Film coated, Extended release · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8556-1 | 68788855601 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8556-1)Marketed from Dec 6, 2023 | |
| 68788-8556-3 | 68788855603 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8556-3)Marketed from Dec 6, 2023 | |
| 68788-8556-6 | 68788855606 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8556-6)Marketed from Dec 6, 2023 | |
| 68788-8556-9 | 68788855609 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8556-9)Marketed from Dec 6, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- 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 68788-8556_7307b838-12d2-4a8a-b99f-8ed1be52f6c2SPL ID 7307b838-12d2-4a8a-b99f-8ed1be52f6c2SPL set ID 453a5759-2f0d-421d-be78-81ab97c8ce77RxCUI 1874553UNII 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
N468788855601followed by a unit qualifier and the quantityPackage 68788-8556-01. 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 25 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-604 |
| 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 |