Prescription drug · ANDA
Desvenlafaxine NDC 0054-0400
Desvenlafaxine succinate 50 mg/1 · Tablet, Film coated, Extended release · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0400-13 | 0005404001300054040013 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0400-13)Marketed from Mar 1, 2017 | |
| 0054-0400-22 | 0005404002200054040022 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0400-22)Marketed from Mar 1, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 50 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204083
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0054-0400_c5148154-683f-4369-bb65-9f6f43a64e2bSPL ID c5148154-683f-4369-bb65-9f6f43a64e2bSPL set ID 662890ff-d254-40e0-a9fe-f07ab94d65d6RxCUI 1607617, 1874553, 1874559UNII ZB22ENF0XRUPC 0300540400132, 0300540603137
- 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
N400054040013followed by a unit qualifier and the quantityPackage 00054-0400-13. 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 0054-0400
- What is NDC 0054-0400?
- 0054-0400 is the product NDC for Desvenlafaxine, Desvenlafaxine succinate 50 mg/1 tablet, film coated, extended release, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 204083
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 100 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0401 |
| Desvenlafaxine | Desvenlafaxine succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0603 |