FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
70771-1837
11-digit product format
707711837
Labeler code
70771
Product ID
70771-1837_665f7293-1792-4b57-b8af-3e1fc33e8200
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA090174
Marketing category
ANDA
Marketing start
2023-05-18
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
70771-1837-0Venlafaxine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10001
70771-1837-2Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE101
70771-1837-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
70771-1837-4Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE101
70771-1837-5Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
70771-1837-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1837VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 6 package rows20230520_1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b1
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b1
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b1
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b1
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b1
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b1
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b1
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b1
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1837-0707711837001000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1837-0) 2023-05-18NoNoHistorical
70771-1837-27077118370210 in 1 BLISTER PACKHistorical
70771-1837-37077118370330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1837-3) 2023-05-18NoNoHistorical
70771-1837-47077118370410 BLISTER PACK in 1 CARTON (70771-1837-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1837-2) 10 blister pack2023-05-18NoNoHistorical
70771-1837-570771183705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1837-5) 2023-05-18NoNoHistorical
70771-1837-97077118370990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1837-9) 2023-05-18NoNoHistorical