Prescription drug · NDA AUTHORIZED GENERIC
Venlafaxine Hydrochloride NDC 80425-0477
Venlafaxine hydrochloride 37.5 mg/1 · Tablet, Extended release · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0477-1 | 80425047701 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0477-1)Marketed from Jan 30, 2025 | |
| 80425-0477-2 | 80425047702 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0477-2)Marketed from Jan 30, 2025 | |
| 80425-0477-3 | 80425047703 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0477-3)Marketed from Jan 30, 2025 |
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)
- Venlafaxine Hydrochloride
- Generic name (nonproprietary)
- venlafaxine hydrochloride
- Active ingredients
- Venlafaxine hydrochloride — 37.5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022104
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0477_2d034ebe-1e07-6fe0-e063-6394a90a368bSPL ID 2d034ebe-1e07-6fe0-e063-6394a90a368bSPL set ID 2cf6e6ad-7d00-0db1-e063-6394a90ab1ecRxCUI 808751UNII 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
N480425047701followed by a unit qualifier and the quantityPackage 80425-0477-01. 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)
Venlafaxine Extended Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1.1 ) Social Anxiety Disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies ( 14.1 )] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, repre…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022104
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 |
|---|---|---|---|---|
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 37.5 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-712 |
| Venlafaxine Hydrochloride | Venlafaxine hydrochloride 225 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-715 |