What is NDC 80425-0477?

80425-0477 is the product NDC for Venlafaxine Hydrochloride, Venlafaxine hydrochloride 37.5 mg/1 tablet, extended release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?

207 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Venlafaxine Hydrochloride NDC 80425-0477

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0477Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0477Add 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 NDC	11-digit (billing)	Package
80425-0477-1	8042504770180425047701	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0477-1)Marketed from Jan 30, 2025
80425-0477-2	8042504770280425047702	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0477-2)Marketed from Jan 30, 2025
80425-0477-3	8042504770380425047703	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
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022104
Marketing start: Jan 30, 2025
Listing expires: Dec 31, 2026
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

N480425047701 followed by a unit qualifier and the quantity

Package 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 Jan 31, 2025. 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.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0477

What is NDC 80425-0477?: 80425-0477 is the product NDC for Venlafaxine Hydrochloride, Venlafaxine hydrochloride 37.5 mg/1 tablet, extended release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Venlafaxine Hydrochloride.
What is the active ingredient?: Venlafaxine hydrochloride.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?: 207 other product NDCs are listed under this name. See all Venlafaxine Hydrochloride 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-125	24658-0125-1024658-0125-3024658-0125-90
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-126	24658-0126-1024658-0126-3024658-0126-90
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 150 mg/1	Capsule, Extended releaseOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-127	24658-0127-0524658-0127-3024658-0127-90
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	Coupler LLC	67046-0390	67046-0390-03
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	Coupler LLC	67046-0527	67046-0527-03
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	NorthStar RxLLC	72603-747	72603-0747-01
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	NorthStar RxLLC	72603-748	72603-0748-01
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 150 mg/1	Capsule, Extended releaseOral	NorthStar RxLLC	72603-749	72603-0749-01
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4632	70518-4632-00
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	Advanced Rx of Tennessee, LLC	80425-0581	80425-0581-0180425-0581-0280425-0581-03

All 208 Venlafaxine Hydrochloride NDCs

Other NDCs under NDA 022104

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

FDA NDC Directory listings under NDA 022104
Product	Strength	Form · route	Labeler	Product NDC
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Tablet, Extended releaseOral	Trigen Laboratories, LLC	13811-712