FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
68382-035
11-digit product format
683820035
Labeler code
68382
Product ID
68382-035_8c02c121-fe14-45f5-b2bc-b09fd377531f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA090174
Marketing category
ANDA
Marketing start
2011-06-01
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581, 313583, 313585

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-035-06venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3016
68382-035-10venlafaxine hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100016
68382-035-16venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-035-06EA - Each68382-03535b3d92a-ccf4-4dcb-93ca-7299e2fa03d912012-07-24
68382-035-10EA - Each68382-0356fca5733-a244-4545-bb5c-fc3d6c15f9b012012-07-24
68382-035-16EA - Each68382-03532ac07e6-261a-4a4c-815d-a5d56b10724712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BIVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]6
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SVENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BIVENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-035VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 3 package rows20221023_5351fe67-17d9-42ec-9e8b-6585fdb9e29e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNf02cc6e8-186f-46e8-9675-70fd55d002c4101
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDf02cc6e8-186f-46e8-9675-70fd55d002c4101
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYf02cc6e8-186f-46e8-9675-70fd55d002c4101
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNb49a550b-cd80-4e24-9ae9-52d362e36bdf18
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNb49a550b-cd80-4e24-9ae9-52d362e36bdf18
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDb49a550b-cd80-4e24-9ae9-52d362e36bdf18
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDb49a550b-cd80-4e24-9ae9-52d362e36bdf18
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYb49a550b-cd80-4e24-9ae9-52d362e36bdf18
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYb49a550b-cd80-4e24-9ae9-52d362e36bdf18
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN5351fe67-17d9-42ec-9e8b-6585fdb9e29e16
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN5351fe67-17d9-42ec-9e8b-6585fdb9e29e16
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN5351fe67-17d9-42ec-9e8b-6585fdb9e29e16
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD5351fe67-17d9-42ec-9e8b-6585fdb9e29e16
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD5351fe67-17d9-42ec-9e8b-6585fdb9e29e16
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD5351fe67-17d9-42ec-9e8b-6585fdb9e29e16
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY5351fe67-17d9-42ec-9e8b-6585fdb9e29e16
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY5351fe67-17d9-42ec-9e8b-6585fdb9e29e16
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY5351fe67-17d9-42ec-9e8b-6585fdb9e29e16
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNb4481d2d-e26f-49b7-be15-947092cde49c7
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDb4481d2d-e26f-49b7-be15-947092cde49c7
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYb4481d2d-e26f-49b7-be15-947092cde49c7
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN8c3ef876-1922-f718-e053-2a95a90ad0872
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN0da9518a-52f9-4cef-84c4-a82779ea6eed2
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD8c3ef876-1922-f718-e053-2a95a90ad0872
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD0da9518a-52f9-4cef-84c4-a82779ea6eed2
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY8c3ef876-1922-f718-e053-2a95a90ad0872
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY0da9518a-52f9-4cef-84c4-a82779ea6eed2
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNbf02096b-a1fc-cd60-e053-2a95a90a4b991
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN05342f5f-84ca-476d-bed3-5492015e54591
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD05342f5f-84ca-476d-bed3-5492015e54591
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDbf02096b-a1fc-cd60-e053-2a95a90a4b991
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYbf02096b-a1fc-cd60-e053-2a95a90a4b991
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY05342f5f-84ca-476d-bed3-5492015e54591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-035-066838200350630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-035-06) 2011-06-010000-00-00NoNoCurrent
68382-035-10683820035101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-035-10) 2011-06-010000-00-00NoNoCurrent
68382-035-166838200351690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-035-16) 2011-06-010000-00-00NoNoCurrent