What is NDC 75834-219?

75834-219 is the product NDC for Venlafaxine Hydrochloride, Venlafaxine hydrochloride 225 mg/1 tablet, extended release, listed with the FDA by Nivagen Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Nivagen Pharmaceuticals, Inc., NDC labeler code 75834. 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 75834-219

NDC codes

FDA NDC Directory

Product NDC (as listed)75834-219Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75834-0219Add 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
75834-219-00	7583402190075834021900	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-219-00)Marketed from Sep 6, 2019
75834-219-30	7583402193075834021930	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-219-30)Marketed from Sep 6, 2019
75834-219-90	7583402199075834021990	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-219-90)Marketed from Sep 6, 2019

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 Hydrochloride
Generic name (nonproprietary): venlafaxine hydrochloride
Active ingredients: Venlafaxine hydrochloride — 225 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Nivagen Pharmaceuticals, Inc.NDC labeler code 75834
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211323
Marketing start: Sep 6, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 75834-219_bb5cc2c4-6d14-42aa-a9af-dc29bae4f238SPL ID bb5cc2c4-6d14-42aa-a9af-dc29bae4f238SPL set ID 45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e1RxCUI 808744, 808748, 808753UNII 7D7RX5A8MOUPC 0375834217000, 0375834219004
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

N475834021900 followed by a unit qualifier and the quantity

Package 75834-0219-00. 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 14, 2021. 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 previou…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 75834-219

What is NDC 75834-219?: 75834-219 is the product NDC for Venlafaxine Hydrochloride, Venlafaxine hydrochloride 225 mg/1 tablet, extended release, listed with the FDA by Nivagen Pharmaceuticals, Inc.. 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?: Nivagen Pharmaceuticals, Inc., NDC labeler code 75834. 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 ANDA 211323

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

FDA NDC Directory listings under ANDA 211323
Product	Strength	Form · route	Labeler	Product NDC
Venlafaxine	Venlafaxine hydrochloride 75 mg/1	Tablet, CoatedOral	Cadila Pharmaceuticals Limited	71209-087
Venlafaxine	Venlafaxine hydrochloride 150 mg/1	Tablet, CoatedOral	Cadila Pharmaceuticals Limited	71209-088
Venlafaxine	Venlafaxine hydrochloride 225 mg/1	Tablet, CoatedOral	Cadila Pharmaceuticals Limited	71209-089
Venlafaxine	Venlafaxine hydrochloride 75 mg/1	Tablet, CoatedOral	Modavar Pharmaceuticals LLC	72241-075
Venlafaxine	Venlafaxine hydrochloride 150 mg/1	Tablet, CoatedOral	Modavar Pharmaceuticals LLC	72241-076
Venlafaxine	Venlafaxine hydrochloride 225 mg/1	Tablet, CoatedOral	Modavar Pharmaceuticals LLC	72241-077
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Tablet, Extended releaseOral	Nivagen Pharmaceuticals, Inc.	75834-217
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 150 mg/1	Tablet, Extended releaseOral	Nivagen Pharmaceuticals, Inc.	75834-218