NDC codes

FDA NDC Directory
Product NDC (as listed)43598-944Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0944Add 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
43598-944-30435980944304359809443030 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-944-30)Marketed from Sep 20, 2021
43598-944-90435980944904359809449090 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-944-90)Marketed from Sep 20, 2021

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
Active ingredients
Venlafaxine hydrochloride — 225 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Dr. Reddy's Laboratories Inc.NDC labeler code 43598
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214609
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 43598-944_79d34297-6604-4031-a89a-8ec557d078d1SPL ID 79d34297-6604-4031-a89a-8ec557d078d1SPL set ID 9312f4df-63d9-4167-880f-36a816870442RxCUI 808744, 808748UNII 7D7RX5A8MOUPC 0343598943909, 0343598944906, 0343598944302, 0343598943305

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

N443598094430 followed by a unit qualifier and the quantity

Package 43598-0944-30. 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 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, representing a change from previo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-944

What is NDC 43598-944?
43598-944 is the product NDC for Venlafaxine, Venlafaxine hydrochloride 225 mg/1 tablet, extended release, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Venlafaxine.
What is the active ingredient?
Venlafaxine hydrochloride.
Who is the labeler?
Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Venlafaxine?
118 other product NDCs are listed under this name. See all Venlafaxine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Venlafaxine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
VenlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralREMEDYREPACK INC.70518-477970518-4779-00
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralCoupler LLC67046-056067046-0560-03
venlafaxineVenlafaxine hydrochloride 50 mg/1TabletOralCoupler LLC67046-168167046-1681-03
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralCoupler LLC67046-202067046-2020-03
VenlafaxineVenlafaxine hydrochloride 75 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-456670518-4566-00
VenlafaxineVenlafaxine hydrochloride 150 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-450070518-4500-00
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralREMEDYREPACK INC.70518-416870518-4168-00
VenlafaxineVenlafaxine hydrochloride 75 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-382070518-3820-00
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralNorthwind Health Company, LLC51655-32351655-0323-52
VenlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-72860760-0728-60

All 119 Venlafaxine NDCs

Other NDCs under ANDA 214609

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

FDA NDC Directory listings under ANDA 214609
ProductStrengthForm · routeLabelerProduct NDC
VenlafaxineVenlafaxine hydrochloride 150 mg/1Tablet, Extended releaseOralDr. Reddy's Laboratories Inc.43598-943

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