Prescription drug · ANDA

Venlafaxine NDC 68382-101

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

NDC codes

FDA NDC Directory
Product NDC (as listed)68382-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0101Add 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
68382-101-0168382010101100 TABLET in 1 BOTTLE (68382-101-01)Marketed from Jun 13, 2008
68382-101-0568382010105500 TABLET in 1 BOTTLE (68382-101-05)Marketed from Jun 13, 2008
68382-101-066838201010630 TABLET in 1 BOTTLE (68382-101-06)Marketed from Jun 13, 2008
68382-101-10683820101101000 TABLET in 1 BOTTLE (68382-101-10)Marketed from Jun 13, 2008
68382-101-146838201011460 TABLET in 1 BOTTLE (68382-101-14)Marketed from Jun 13, 2008
68382-101-166838201011690 TABLET in 1 BOTTLE (68382-101-16)Marketed from Jun 13, 2008

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
Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077653
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68382-101_ea404f6c-7e07-4779-a52c-8cffb92718efSPL ID ea404f6c-7e07-4779-a52c-8cffb92718efSPL set ID 72efad5f-0909-46a5-aa13-ac24fe015fe6RxCUI 313580, 313582, 313584, 313586, 314277UNII 7D7RX5A8MOUPC 0368382019011, 0368382018014, 0368382021014, 0368382101013

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

N468382010101 followed by a unit qualifier and the quantity

Package 68382-0101-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP 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 incl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-101

What is NDC 68382-101?
68382-101 is the product NDC for Venlafaxine, Venlafaxine hydrochloride 100 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 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?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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?
116 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 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
VenlafaxineVenlafaxine hydrochloride 225 mg/1Tablet, Extended releaseOralAjanta Pharma USA Inc.27241-22427241-0224-3027241-0224-90

All 117 Venlafaxine NDCs

Other NDCs under ANDA 077653

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

FDA NDC Directory listings under ANDA 077653
ProductStrengthForm · routeLabelerProduct NDC
VenlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralA-S Medication Solutions50090-2408
VenlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralA-S Medication Solutions50090-4865
VenlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-728
VenlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralProficient Rx LP63187-414
VenlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralBryant Ranch Prepack63629-3324
VenlafaxineVenlafaxine hydrochloride 100 mg/1TabletOralBluePoint Laboratories68001-156
VenlafaxineVenlafaxine hydrochloride 25 mg/1TabletOralBluePoint Laboratories68001-157
VenlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralBluePoint Laboratories68001-158
VenlafaxineVenlafaxine hydrochloride 50 mg/1TabletOralBluePoint Laboratories68001-159
VenlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralBluePoint Laboratories68001-160
VenlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2990
VenlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3431
VenlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3432
VenlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralAmerican Health Packaging68084-844
VenlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralAmerican Health Packaging68084-856
VenlafaxineVenlafaxine hydrochloride 25 mg/1TabletOralAmerican Health Packaging68084-896
VenlafaxineVenlafaxine hydrochloride 25 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-018
VenlafaxineVenlafaxine hydrochloride 37.5 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-019
VenlafaxineVenlafaxine hydrochloride 50 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-020
VenlafaxineVenlafaxine hydrochloride 75 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-021

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