Prescription drug · ANDA
Desvenlafaxine NDC 72603-557
Desvenlafaxine succinate 100 mg/1 · Tablet, Extended release · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-557-01 | 72603055701 | 90 TABLET, EXTENDED RELEASE in 1 PACKAGE (72603-557-01)Marketed from May 2, 2025 |
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
- Generic name (nonproprietary)
- desvenlafaxine
- Active ingredients
- Desvenlafaxine succinate — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204028
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 72603-557_34888df6-f68d-c171-e063-6294a90a7604SPL ID 34888df6-f68d-c171-e063-6294a90a7604SPL set ID 3fcc0555-f9cf-4735-a0ef-830c50c390b8RxCUI 1607617, 1874553, 1874559UNII ZB22ENF0XRUPC 0372603555011, 0372603557015, 0372603556025, 0372603556018
- 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
N472603055701followed by a unit qualifier and the quantityPackage 72603-0557-01. 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 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 204028
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 | A-S Medication Solutions | 50090-7737 |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7190 |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2490 |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 72603-555 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 72603-556 |
| Desvenlafaxine | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2512 |
| Desvenlafaxine ER | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Direct_rx | 72189-567 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Advagen Pharma Ltd | 72888-143 |
| Desvenlafaxine | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Advagen Pharma Ltd | 72888-144 |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | Advagen Pharma Ltd | 72888-175 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3790 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2575 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8760 |