Venlafaxine Hydrochloride

Product NDC
33261-816
11-digit product format
332610816
Labeler code
33261
Product ID
33261-816_8d4746af-7b95-4b44-9010-cc77908c2987
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076565
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-816-30Venlafaxine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE301
33261-816-90Venlafaxine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-816-30EA - Each33261-8162f495e71-5f37-42d9-ba8c-599c6356dbfb12015-10-02
33261-816-90EA - Each33261-81614bc6431-d130-43c5-83b5-852dd705786112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ETHYLCELLULOSE (7 MPA.S)INACTIVE INGREDIENTH3UP11403CVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-816VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140213_332dca93-9296-48b6-a039-246783991bd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN332dca93-9296-48b6-a039-246783991bd51
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN332dca93-9296-48b6-a039-246783991bd51
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD332dca93-9296-48b6-a039-246783991bd51
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD332dca93-9296-48b6-a039-246783991bd51
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY332dca93-9296-48b6-a039-246783991bd51
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY332dca93-9296-48b6-a039-246783991bd51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-816-303326108163030 in 1 BOTTLE, PLASTICHistorical
33261-816-903326108169090 in 1 BOTTLE, PLASTICHistorical