NDC codes

FDA NDC Directory
Product NDC (as listed)33342-194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0194Add 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
33342-194-073334201940730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-07)Marketed from Oct 6, 2017
33342-194-103334201941090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-10)Marketed from Aug 14, 2018
33342-194-1133342019411100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-11)Marketed from Aug 14, 2018
33342-194-1533342019415500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-15)Marketed from Oct 6, 2017

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 — 37.5 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204889
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 33342-194_f913aca4-ac1e-475d-80ed-f48c7c2666c5SPL ID f913aca4-ac1e-475d-80ed-f48c7c2666c5SPL set ID 3e51f786-3691-4ec4-836b-7f2c9a385aa7RxCUI 313581, 313583, 313585UNII 7D7RX5A8MOUPC 0333342195074, 0333342196071, 0333342194152, 0333342196156, 0333342194077

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

N433342019407 followed by a unit qualifier and the quantity

Package 33342-0194-07. 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)

About NDC 33342-194

What is NDC 33342-194?
33342-194 is the product NDC for Venlafaxine hydrochloride, Venlafaxine hydrochloride 37.5 mg/1 capsule, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 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?
Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?
208 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 209 Venlafaxine hydrochloride NDCs

Other NDCs under ANDA 204889

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

FDA NDC Directory listings under ANDA 204889
ProductStrengthForm · routeLabelerProduct NDC
Venlafaxine hydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralMacleods Pharmaceuticals Limited33342-195
Venlafaxine hydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralMacleods Pharmaceuticals Limited33342-196

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