Prescription drug · ANDA

venlafaxine NDC 62332-012

Venlafaxine hydrochloride 100 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)62332-012Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0012Add 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
62332-012-30623320012306233200123030 TABLET in 1 BOTTLE (62332-012-30)Marketed from Oct 1, 2015
62332-012-316233200123162332001231100 TABLET in 1 BOTTLE (62332-012-31)Marketed from Oct 1, 2015
62332-012-9162332001291623320012911000 TABLET in 1 BOTTLE (62332-012-91)Marketed from Oct 1, 2015

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
Generic name (nonproprietary)
venlafaxine
Active ingredients
Venlafaxine hydrochloride — 100 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Alembic Pharmaceuticals Inc.NDC labeler code 62332
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078932
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 62332-012_8724b94d-b3fd-4844-a7fe-2be7982cf8f5SPL ID 8724b94d-b3fd-4844-a7fe-2be7982cf8f5SPL set ID 67b323a7-a8c9-410f-bff0-0e515bef41a7RxCUI 313580, 313582, 313584, 313586, 314277UNII 7D7RX5A8MOUPC 0362332008308, 0362332010301, 0362332012305, 0362332011308

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

N462332001230 followed by a unit qualifier and the quantity

Package 62332-0012-30. 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)

INDICATIONS AND USAGE Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at lea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62332-012

What is NDC 62332-012?
62332-012 is the product NDC for venlafaxine, Venlafaxine hydrochloride 100 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
venlafaxine.
What is the active ingredient?
Venlafaxine hydrochloride.
Who is the labeler?
Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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?
118 other product NDCs are listed under this name. See all venlafaxine 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
VenlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralREMEDYREPACK INC.70518-477970518-4779-00
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralCoupler LLC67046-056067046-0560-03
venlafaxineVenlafaxine hydrochloride 50 mg/1TabletOralCoupler LLC67046-168167046-1681-03
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralCoupler LLC67046-202067046-2020-03
VenlafaxineVenlafaxine hydrochloride 75 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-456670518-4566-00
VenlafaxineVenlafaxine hydrochloride 150 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-450070518-4500-00
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralREMEDYREPACK INC.70518-416870518-4168-00
VenlafaxineVenlafaxine hydrochloride 75 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-382070518-3820-00
venlafaxinevenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralNorthwind Health Company, LLC51655-32351655-0323-52
VenlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-72860760-0728-60

All 119 venlafaxine NDCs

Other NDCs under ANDA 078932

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

FDA NDC Directory listings under ANDA 078932
ProductStrengthForm · routeLabelerProduct NDC
venlafaxineVenlafaxine hydrochloride 50 mg/1TabletOralCoupler LLC67046-1681
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralCoupler LLC67046-2020
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralBryant Ranch Prepack71335-0778
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralSt Mary's Medical Park Pharmacy60760-713
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3643
venlafaxineVenlafaxine hydrochloride 25 mg/1TabletOralProficient Rx LP82804-124
venlafaxineVenlafaxine hydrochloride 100 mg/1TabletOralProficient Rx LP63187-752
venlafaxineVenlafaxine hydrochloride 25 mg/1TabletOralAlembic Pharmaceuticals Limited46708-430
venlafaxineVenlafaxine hydrochloride 100 mg/1TabletOralAlembic Pharmaceuticals Limited46708-434
venlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralAlembic Pharmaceuticals Limited46708-431
venlafaxineVenlafaxine hydrochloride 50 mg/1TabletOralAlembic Pharmaceuticals Limited46708-432
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralAlembic Pharmaceuticals Limited46708-433
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralA-S Medication Solutions50090-4715
venlafaxineVenlafaxine hydrochloride 100 mg/1TabletOralNorthwind Health Company, LLC51655-717
venlafaxineVenlafaxine hydrochloride 100 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3433
venlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-011
venlafaxineVenlafaxine hydrochloride 25 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-008
venlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-009
venlafaxineVenlafaxine hydrochloride 50 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-010
venlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralNorthwind Health Company, LLC51655-332

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