Prescription drug · ANDA

Venlafaxine Hydrochloride NDC 82009-057

Venlafaxine hydrochloride 75 mg/1 · Capsule, Extended release · Oral · QUALLENT PHARMACEUTICALS HEALTH LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)82009-057Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82009-0057Add 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
82009-057-10820090057101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82009-057-10)Marketed from Nov 21, 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 hydrochloride
Active ingredients
Venlafaxine hydrochloride — 75 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200834
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 82009-057_b5d4c4fe-1c29-466a-9ca6-6267c7a954ebSPL ID b5d4c4fe-1c29-466a-9ca6-6267c7a954ebSPL set ID cb4c04a6-47d1-44ff-8d58-718102fa08ebRxCUI 313581, 313583, 313585UNII 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

N482009005710 followed by a unit qualifier and the quantity

Package 82009-0057-10. 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 capsules are indicated in adults for the treatment of: Major Depressive Disorder (MDD) [see Clinical Studies (14.1) ] Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2) ] Social Anxiety Disorder (SAD) [see Clinical Studies (14.3) ] Panic Disorder (PD) [see Clinical Studies (14.4) ] Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: Major Depressive Disorder ( MDD ) ( 1 ) Generalized Anxiety Disorder ( GAD ) ( 1 ) Social Anxiety Disorder ( SAD ) ( 1 ) Panic Disorder ( PD ) ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200834

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

FDA NDC Directory listings under ANDA 200834
ProductStrengthForm · routeLabelerProduct NDC
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-3886
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7940
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7489
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-058
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-056
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralAsclemed USA, Inc.76420-632
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralAsclemed USA, Inc.76420-630
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralAsclemed USA, Inc.76420-631
Venlafaxine HCL ERVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralDirect_Rx72189-414
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited65862-697
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralQPharma, Inc.42708-194
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-2107
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8140
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-5160
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralProficient Rx LP71205-369
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-2259
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-1864
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralCoupler LLC67046-0527
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralProficient Rx LP71205-408
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralAmerican Health Packaging68084-698

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Venlafaxine Hydrochloride NDC 82009-057 | Med-Code