Prescription drug · ANDA
Desvenlafaxine NDC 50090-4806
Desvenlafaxine succinate 50 mg/1 · Tablet, Film coated, Extended release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4806-0 | 5009048060050090480600 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4806-0)Marketed from Dec 23, 2019 | |
| 50090-4806-1 | 5009048060150090480601 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4806-1)Marketed from Nov 26, 2024 |
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
- Generic name (nonproprietary)
- desvenlafaxine
- Active ingredients
- Desvenlafaxine succinate — 50 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204082
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-4806_63c611a8-0cbe-4445-a075-65b6443166a8SPL ID 63c611a8-0cbe-4445-a075-65b6443166a8SPL set ID 7107a864-fcb3-4cbf-9fcb-061bef13be2dRxCUI 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
N450090480600followed by a unit qualifier and the quantityPackage 50090-4806-00. 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.
About NDC 50090-4806
- What is NDC 50090-4806?
- 50090-4806 is the product NDC for Desvenlafaxine, Desvenlafaxine succinate 50 mg/1 tablet, film coated, extended release, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Desvenlafaxine.
- What is the active ingredient?
- Desvenlafaxine succinate.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Desvenlafaxine?
- 52 other product NDCs are listed under this name. See all Desvenlafaxine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Desvenlafaxine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-821 | 10135-0821-1010135-0821-1410135-0821-30+1 more |
| Desvenlafaxine | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-822 | 10135-0822-1010135-0822-1410135-0822-30+1 more |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-5332 | 68071-5332-03 |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 72603-555 | 72603-0555-01 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 72603-556 | 72603-0556-0172603-0556-02 |
| Desvenlafaxine | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | NorthStar Rx LLC | 72603-557 | 72603-0557-01 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8760 | 68788-8760-0168788-8760-0368788-8760-06+1 more |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7190 | 50090-7190-0050090-7190-01 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7737 | 50090-7737-0050090-7737-01 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3790 | 68071-3790-03 |
Other NDCs under ANDA 204082
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, Film coated, Extended releaseOral | American Health Packaging | 60687-607 |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-7524 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1700 |