Prescription drug · ANDA
Desvenlafaxine (Desvenlafaxine succinate) NDC 51991-006
Desvenlafaxine succinate 25 mg/1 · Tablet, Extended release · Oral · Breckenridge Pharmaceutical, Inc
NDC codes
FDA NDC DirectoryProduct NDC (as listed)51991-006Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51991-0006Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-006-01 | 5199100060151991000601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-006-01)Marketed from Nov 28, 2018 | |
| 51991-006-10 | 5199100061051991000610 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-006-10)Marketed from Nov 28, 2018 | |
| 51991-006-11 | 5199100061151991000611 | 100 TABLET, EXTENDED RELEASE in 1 CARTON (51991-006-11)Marketed from Nov 28, 2018 | |
| 51991-006-33 | 5199100063351991000633 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-006-33)Marketed from Nov 28, 2018 | |
| 51991-006-80 | 5199100068051991000680 | 80 TABLET, EXTENDED RELEASE in 1 CARTON (51991-006-80)Marketed from Nov 28, 2018 | |
| 51991-006-90 | 5199100069051991000690 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-006-90)Marketed from Nov 28, 2018 |
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 succinate
- Active ingredients
- Desvenlafaxine succinate — 25 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Breckenridge Pharmaceutical, IncNDC labeler code 51991
- 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 51991-006_8e532045-4ca8-423d-a070-29b81fb0823fSPL ID 8e532045-4ca8-423d-a070-29b81fb0823fSPL set ID 25bdfc41-c7cb-4d16-b6a8-f102f9b8c984RxCUI 1607617, 1874553, 1874559UNII ZB22ENF0XRUPC 0063308000080
- 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
N451991000601followed by a unit qualifier and the quantityPackage 51991-0006-01. 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 51991-006
- What is NDC 51991-006?
- 51991-006 is the product NDC for Desvenlafaxine (desvenlafaxine succinate), Desvenlafaxine succinate 25 mg/1 tablet, extended release, listed with the FDA by Breckenridge Pharmaceutical, Inc. It has 6 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?
- Breckenridge Pharmaceutical, Inc, NDC labeler code 51991. 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 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 100 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-7175 |
| 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 |