Prescription drug · ANDA

venlafaxine (venlafaxine hydrochloride) NDC 67046-0560

Venlafaxine hydrochloride 37.5 mg/1 · Tablet · Oral · Coupler LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67046-0560Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-0560Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
67046-0560-36704605600330 TABLET in 1 BLISTER PACK (67046-0560-3)Marketed from Jun 10, 2026

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
Generic name (nonproprietary)
venlafaxine hydrochloride
Active ingredients
Venlafaxine hydrochloride — 37.5 mg/1
Dosage form
Tablet
Route
Oral
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 67046-0560_53e5a91a-85c9-373b-e063-6394a90ad909SPL ID 53e5a91a-85c9-373b-e063-6394a90ad909SPL set ID 53e5c5a2-b8e7-3d75-e063-6294a90a508bRxCUI 313584UNII 7D7RX5A8MO

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

N467046056003 followed by a unit qualifier and the quantity

Package 67046-0560-03. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090555

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090555
ProductStrengthForm · routeLabelerProduct NDC
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 100 mg/1TabletOralREMEDYREPACK INC.70518-1976
Venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralAurobindo Pharma Limited65862-405
Venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 25 mg/1TabletOralAurobindo Pharma Limited65862-404
Venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 50 mg/1TabletOralAurobindo Pharma Limited65862-406
Venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 75 mg/1TabletOralAurobindo Pharma Limited65862-407
Venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 100 mg/1TabletOralAurobindo Pharma Limited65862-408
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 75 mg/1TabletOralBryant Ranch Prepack71335-1104
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 75 mg/1TabletOralNorthwind Health Company, LLC51655-223
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralA-S Medication Solutions50090-4853
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralREMEDYREPACK INC.70518-1385
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralNorthwind Health Company, LLC51655-323
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralBryant Ranch Prepack71335-1213
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 75 mg/1TabletOralREMEDYREPACK INC.70518-2652
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 25 mg/1TabletOralREMEDYREPACK INC.70518-2659
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 25 mg/1TabletOralRising Pharma Holdings, Inc.57237-172
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 75 mg/1TabletOralRising Pharma Holdings, Inc.57237-175
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralRising Pharma Holdings, Inc.57237-173
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 50 mg/1TabletOralRising Pharma Holdings, Inc.57237-174
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 100 mg/1TabletOralRising Pharma Holdings, Inc.57237-176
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 50 mg/1TabletOralREMEDYREPACK INC.70518-1907

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