NDC codes

FDA NDC Directory
Product NDC (as listed)42799-963Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42799-0963Add 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
42799-963-014279909630130 TABLET in 1 BOTTLE (42799-963-01)Marketed from Mar 15, 2023
42799-963-024279909630290 TABLET in 1 BOTTLE (42799-963-02)Marketed from Mar 15, 2023

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

Generic name (nonproprietary)
venlafaxine hydrochloride, extended release
Active ingredients
Venlafaxine hydrochloride — 225 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Edenbridge Pharmaceuticals LLC.NDC labeler code 42799
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209193
Marketing start
Marketing end
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 42799-963_157aa0f9-6266-4758-9d6b-5fc77cdc03a4SPL ID 157aa0f9-6266-4758-9d6b-5fc77cdc03a4SPL set ID 38431a76-6185-4c17-994f-8278b6cd7510RxCUI 808744, 808748UNII 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

N442799096301 followed by a unit qualifier and the quantity

Package 42799-0963-01. 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 Hydrochloride 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 Hydrochloride 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, repre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42799-963

What is NDC 42799-963?
42799-963 is the product NDC for venlafaxine hydrochloride, extended release, Venlafaxine hydrochloride 225 mg/1 tablet, listed with the FDA by Edenbridge Pharmaceuticals LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
venlafaxine hydrochloride, extended release.
What is the active ingredient?
Venlafaxine hydrochloride.
Who is the labeler?
Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. 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 hydrochloride, extended release?
1 other product NDC are listed under this name. See all venlafaxine hydrochloride, extended release 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 hydrochloride, extended release NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
venlafaxine hydrochloride, extended releaseVenlafaxine hydrochloride 150 mg/1TabletOralEdenbridge Pharmaceuticals LLC.42799-96242799-0962-0142799-0962-02

Other NDCs under ANDA 209193

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

FDA NDC Directory listings under ANDA 209193
ProductStrengthForm · routeLabelerProduct NDC
venlafaxine hydrochlorideVenlafaxine hydrochloride 225 mg/1TabletOralChartwell RX, LLC62135-531
venlafaxine hydrochloride, extended releaseVenlafaxine hydrochloride 150 mg/1TabletOralEdenbridge Pharmaceuticals LLC.42799-962

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venlafaxine hydrochloride, extended release NDC 42799-963 | Med-Code