Prescription drug · ANDA

Venlafaxine Hydrochloride NDC 82804-038

Venlafaxine hydrochloride 150 mg/1 · Capsule, Extended release · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)82804-038Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0038Add 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
82804-038-308280400383030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-038-30)Marketed from Nov 7, 2023
82804-038-608280400386060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-038-60)Marketed from Nov 7, 2023
82804-038-908280400389090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-038-90)Marketed from Nov 7, 2023

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 — 150 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 82804
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 82804-038_5c558ab8-b4b3-4973-b016-ed5cfcb4d88bSPL ID 5c558ab8-b4b3-4973-b016-ed5cfcb4d88bSPL set ID 5c558ab8-b4b3-4973-b016-ed5cfcb4d88bRxCUI 313581UNII 7D7RX5A8MOUPC 0382804038305

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

N482804003830 followed by a unit qualifier and the quantity

Package 82804-0038-30. 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)

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 ( Error! Hyperlink reference not valid. ) ( 1 ) • Generalized Anxiety Disorder ( GAD ) ( 1 ) • Social Anxiety Disorder ( Error! Hyperlink reference not valid. ) ( 1 ) •…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-038

What is NDC 82804-038?
82804-038 is the product NDC for Venlafaxine Hydrochloride, Venlafaxine hydrochloride 150 mg/1 capsule, extended release, listed with the FDA by Proficient Rx LP. It has 3 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?
Proficient Rx LP, NDC labeler code 82804. 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 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 HCL ERVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralDirect_Rx72189-363
Venlafaxine HCL ERVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralDirect_Rx72189-414
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7487
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7488
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7489
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralQPharma, Inc.42708-194
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-2180
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-2281
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-2519
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-6517
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-6599
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-6896
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7940
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7941
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7942
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralNorthwind Health Company, LLC51655-849
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralCardinal Health 107, LLC55154-0197
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralST. MARY'S MEDICAL PARK PHARMACY60760-836
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited65862-527
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited65862-528

Showing 20 of 40.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in