Prescription drug · ANDA

Venlafaxine Hydrochloride (Venlafaxine) NDC 64980-581

Venlafaxine hydrochloride 225 mg/1 · Tablet, Extended release · Oral · Rising Pharma Holdings, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)64980-581Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0581Add 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
64980-581-03649800581036498005810330 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-581-03)Marketed from Nov 28, 2022
64980-581-09649800581096498005810990 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-581-09)Marketed from Nov 28, 2022

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
Active ingredients
Venlafaxine hydrochloride — 225 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216044
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 64980-581_7f187899-ddc6-4e15-b2af-e54f59d5baf4SPL ID 7f187899-ddc6-4e15-b2af-e54f59d5baf4SPL set ID 074f4478-e81b-45a2-ae85-ffd27bed940fRxCUI 808744, 808748, 808751, 808753UNII 7D7RX5A8MOUPC 0364980578035, 0364980579032, 0364980581035, 0364980580038

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

N464980058103 followed by a unit qualifier and the quantity

Package 64980-0581-03. 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)

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 previ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64980-581

What is NDC 64980-581?
64980-581 is the product NDC for Venlafaxine Hydrochloride (venlafaxine), Venlafaxine hydrochloride 225 mg/1 tablet, extended release, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Venlafaxine Hydrochloride (Venlafaxine).
What is the active ingredient?
Venlafaxine hydrochloride.
Who is the labeler?
Rising Pharma Holdings, Inc., NDC labeler code 64980. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-12524658-0125-1024658-0125-3024658-0125-90
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-12624658-0126-1024658-0126-3024658-0126-90
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-12724658-0127-0524658-0127-3024658-0127-90
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralCoupler LLC67046-039067046-0390-03
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralCoupler LLC67046-052767046-0527-03
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralNorthStar RxLLC72603-74772603-0747-01
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralNorthStar RxLLC72603-74872603-0748-01
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralNorthStar RxLLC72603-74972603-0749-01
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-463270518-4632-00
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralAdvanced Rx of Tennessee, LLC80425-058180425-0581-0180425-0581-0280425-0581-03

All 208 Venlafaxine Hydrochloride NDCs

Other NDCs under ANDA 216044

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

FDA NDC Directory listings under ANDA 216044
ProductStrengthForm · routeLabelerProduct NDC
Venlafaxine HydrochloridevenlafaxineVenlafaxine hydrochloride 37.5 mg/1Tablet, Extended releaseOralRising Pharma Holdings, Inc.64980-578
Venlafaxine HydrochloridevenlafaxineVenlafaxine hydrochloride 75 mg/1Tablet, Extended releaseOralRising Pharma Holdings, Inc.64980-579
Venlafaxine HydrochloridevenlafaxineVenlafaxine hydrochloride 150 mg/1Tablet, Extended releaseOralRising Pharma Holdings, Inc.64980-580
Venlafaxine HydrochloridevenlafaxineVenlafaxine hydrochloride 75 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8825
Venlafaxine HydrochloridevenlafaxineVenlafaxine hydrochloride 75 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4065

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