FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
68382-034
11-digit product format
683820034
Labeler code
68382
Product ID
68382-034_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
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
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
68382-034-06venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3016
68382-034-10venlafaxine hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100016
68382-034-16venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-034-06EA - Each68382-03423a505a3-4127-4d0d-861f-87dcf22af3f412012-07-24
68382-034-10EA - Each68382-034b3d8db48-89bb-4b23-b29d-0ac430ff17e012012-07-24
68382-034-16EA - Each68382-034ced389b3-c4e6-4650-b57b-5c4d4654184712012-07-24

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, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BIVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]4
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-034VENLAFAXINE 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
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
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN01d6c49d-f831-44dc-bd59-dc93ebdeee2f4
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN01d6c49d-f831-44dc-bd59-dc93ebdeee2f4
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN8d6e699b-24bf-4e77-8a7f-acd496a700c74
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD01d6c49d-f831-44dc-bd59-dc93ebdeee2f4
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD8d6e699b-24bf-4e77-8a7f-acd496a700c74
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD01d6c49d-f831-44dc-bd59-dc93ebdeee2f4
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY01d6c49d-f831-44dc-bd59-dc93ebdeee2f4
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY8d6e699b-24bf-4e77-8a7f-acd496a700c74
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY01d6c49d-f831-44dc-bd59-dc93ebdeee2f4
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN3cfc589e-455e-4df3-91e6-6cfece5c420a3
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN3cfc589e-455e-4df3-91e6-6cfece5c420a3
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD3cfc589e-455e-4df3-91e6-6cfece5c420a3
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD3cfc589e-455e-4df3-91e6-6cfece5c420a3
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY3cfc589e-455e-4df3-91e6-6cfece5c420a3
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY3cfc589e-455e-4df3-91e6-6cfece5c420a3
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN908dc8d9-6c94-0c40-e053-2a95a90a2e571
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD908dc8d9-6c94-0c40-e053-2a95a90a2e571
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY908dc8d9-6c94-0c40-e053-2a95a90a2e571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-034-066838200340630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-06) 2011-06-010000-00-00NoNoCurrent
68382-034-10683820034101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-10) 2011-06-010000-00-00NoNoCurrent
68382-034-166838200341690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-16) 2011-06-010000-00-00NoNoCurrent