Prescription drug · ANDA
Venlafaxine (venlafaxine hydrochloride) NDC 65862-404
Venlafaxine hydrochloride 25 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-404-01 | 65862040401 | 100 TABLET in 1 BOTTLE (65862-404-01)Marketed from Apr 7, 2010 | |
| 65862-404-10 | 65862040410 | 10 BLISTER PACK in 1 CARTON (65862-404-10) / 10 TABLET in 1 BLISTER PACKMarketed from Apr 7, 2010 | |
| 65862-404-30 | 65862040430 | 30 TABLET in 1 BOTTLE (65862-404-30)Marketed from Apr 7, 2010 | |
| 65862-404-60 | 65862040460 | 60 TABLET in 1 BOTTLE (65862-404-60)Marketed from Apr 7, 2010 | |
| 65862-404-71 | 65862040471 | 7000 TABLET in 1 BOTTLE (65862-404-71)Marketed from Apr 7, 2010 | |
| 65862-404-90 | 65862040490 | 90 TABLET in 1 BOTTLE (65862-404-90)Marketed from Apr 7, 2010 | |
| 65862-404-99 | 65862040499 | 1000 TABLET in 1 BOTTLE (65862-404-99)Marketed from Apr 7, 2010 |
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)
- Venlafaxine
- Generic name (nonproprietary)
- venlafaxine hydrochloride
- Active ingredients
- Venlafaxine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090555
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-404_426d12db-50e2-4915-999f-84645fb387d9SPL ID 426d12db-50e2-4915-999f-84645fb387d9SPL set ID b23637e5-d37f-41b5-ba76-fc053e903bc2RxCUI 313580, 313582, 313584, 313586, 314277UNII 7D7RX5A8MO
- 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
N465862040401followed by a unit qualifier and the quantityPackage 65862-0404-01. 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)
INDICATIONS AND USAGE Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should incl…
Excerpt only. Read the full label for complete information.
- openFDA data updated
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