Prescription drug · ANDA
Desvenlafaxine (Desvenlafaxine succinate) NDC 68788-7175
Desvenlafaxine succinate 100 mg/1 · Tablet, Extended release · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68788-7175Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7175Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7175-1 | 6878871750168788717501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7175-1)Marketed from Jun 11, 2018 | |
| 68788-7175-3 | 6878871750368788717503 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7175-3)Marketed from Jun 11, 2018 | |
| 68788-7175-6 | 6878871750668788717506 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7175-6)Marketed from Jun 11, 2018 | |
| 68788-7175-9 | 6878871750968788717509 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7175-9)Marketed from Jun 11, 2018 |
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 succinate
- Active ingredients
- Desvenlafaxine succinate — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204003
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-7175_59b42830-3574-450c-9d7b-53e2834c59dbSPL ID 59b42830-3574-450c-9d7b-53e2834c59dbSPL set ID b4a5efab-3765-4ea5-a8cd-66e67e76c845RxCUI 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
N468788717501followed by a unit qualifier and the quantityPackage 68788-7175-01. 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 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 68788-7175
- What is NDC 68788-7175?
- 68788-7175 is the product NDC for Desvenlafaxine (desvenlafaxine succinate), Desvenlafaxine succinate 100 mg/1 tablet, extended release, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Desvenlafaxine (Desvenlafaxine Succinate).
- What is the active ingredient?
- Desvenlafaxine succinate.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 204003
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 |
|---|---|---|---|---|
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-540 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-541 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-542 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5274 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5293 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | Breckenridge Pharmaceutical, Inc | 51991-006 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Breckenridge Pharmaceutical, Inc | 51991-311 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Breckenridge Pharmaceutical, Inc | 51991-312 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-7525 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-7559 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1545 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceutical, Inc. | 68788-7194 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 100 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-586 |
| Desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2130 |
| desvenlafaxinedesvenlafaxine succinate | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 72189-147 |