FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
72865-197
11-digit product format
728650197
Labeler code
72865
Product ID
72865-197_2cdc9267-9619-474a-abe4-a0b85ac3fb2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA214419
Marketing category
ANDA
Marketing start
2021-02-26
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VENLAFAXINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui808744, 808748, 808751, 808753

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-197-30VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
72865-197-90VENLAFAXINE HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-197-30EA - Each72865-1974a91ccae-696d-432f-a8ac-997d41f5e4ca12021-08-05
72865-197-90EA - Each72865-197d01b6d05-d0da-4514-b167-027523228b8d12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-197VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET, EXTENDED RELEASE [XLCARE PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20211120_68f40801-d35e-464e-ac94-21016b617ea2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN68f40801-d35e-464e-ac94-21016b617ea22
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN68f40801-d35e-464e-ac94-21016b617ea22
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSN68f40801-d35e-464e-ac94-21016b617ea22
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN68f40801-d35e-464e-ac94-21016b617ea22
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD68f40801-d35e-464e-ac94-21016b617ea22
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD68f40801-d35e-464e-ac94-21016b617ea22
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCD68f40801-d35e-464e-ac94-21016b617ea22
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD68f40801-d35e-464e-ac94-21016b617ea22
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY68f40801-d35e-464e-ac94-21016b617ea22
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY68f40801-d35e-464e-ac94-21016b617ea22
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY68f40801-d35e-464e-ac94-21016b617ea22
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY68f40801-d35e-464e-ac94-21016b617ea22
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY68f40801-d35e-464e-ac94-21016b617ea22
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSY68f40801-d35e-464e-ac94-21016b617ea22
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY68f40801-d35e-464e-ac94-21016b617ea22
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY68f40801-d35e-464e-ac94-21016b617ea22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-197-307286501973030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-197-30) 2021-02-260000-00-00NoNoCurrent
72865-197-907286501979090 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-197-90) 2021-02-260000-00-00NoNoCurrent