Prescription drug · ANDA
Desvenlafaxine ER NDC 72189-567
Desvenlafaxine succinate 50 mg/1 · Tablet, Extended release · Oral · Direct_rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-567-28 | 7218905672872189056728 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-567-28)Marketed from Jul 18, 2024 | |
| 72189-567-30 | 7218905673072189056730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-567-30)Marketed from Jul 18, 2024 | |
| 72189-567-60 | 7218905676072189056760 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-567-60)Marketed from Jul 18, 2024 |
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 ER
- Generic name (nonproprietary)
- desvenlafaxine er
- Active ingredients
- Desvenlafaxine succinate — 50 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Direct_rxNDC labeler code 72189
- 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 72189-567_34f5586c-4441-54fb-e063-6394a90aa90dSPL ID 34f5586c-4441-54fb-e063-6394a90aa90dSPL set ID 1d86d1dc-d685-43aa-e063-6294a90a9907RxCUI 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
N472189056728followed by a unit qualifier and the quantityPackage 72189-0567-28. 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)].
Excerpt only. Read the full label for complete information.
About NDC 72189-567
- What is NDC 72189-567?
- 72189-567 is the product NDC for Desvenlafaxine ER, Desvenlafaxine succinate 50 mg/1 tablet, extended release, listed with the FDA by Direct_rx. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Desvenlafaxine ER.
- What is the active ingredient?
- Desvenlafaxine succinate.
- Who is the labeler?
- Direct_rx, NDC labeler code 72189. 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 ER?
- 1 other product NDC are listed under this name. See all Desvenlafaxine ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Desvenlafaxine ER 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 ER | Desvenlafaxine succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_Rx | 61919-882 | 61919-0882-2861919-0882-3061919-0882-60 |
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 | Preferred Pharmaceuticals Inc. | 68788-8760 |
| 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 | NorthStar Rx LLC | 72603-557 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2575 |
| 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 | A-S Medication Solutions | 50090-7190 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7737 |
| 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. | 68071-5332 |
| Desvenlafaxine | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3790 |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2490 |
| Desvenlafaxine | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2512 |