FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
71785-1006
11-digit product format
717851006
Labeler code
71785
Product ID
71785-1006_b45cbdea-d1be-c16d-e053-2a95a90a821e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Annora Pharma Private Limited
Application
ANDA212277
Marketing category
ANDA
Marketing start
2019-07-08
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
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71785-1006-0VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
71785-1006-1VENLAFAXINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903
71785-1006-2VENLAFAXINE HYDROCHLORIDE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5003
71785-1006-3VENLAFAXINE HYDROCHLORIDE10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE103
71785-1006-3VENLAFAXINE HYDROCHLORIDE10 in 1 CARTONCAPSULE, EXTENDED RELEASE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71785-1006VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANNORA PHARMA PRIVATE LIMITED]3Current NDC, Legacy NDC, 5 package rows20201202_e901e476-58bd-4204-baaa-a4634ae65ab3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNe901e476-58bd-4204-baaa-a4634ae65ab33
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNe901e476-58bd-4204-baaa-a4634ae65ab33
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNe901e476-58bd-4204-baaa-a4634ae65ab33
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDe901e476-58bd-4204-baaa-a4634ae65ab33
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDe901e476-58bd-4204-baaa-a4634ae65ab33
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDe901e476-58bd-4204-baaa-a4634ae65ab33
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYe901e476-58bd-4204-baaa-a4634ae65ab33
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYe901e476-58bd-4204-baaa-a4634ae65ab33
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYe901e476-58bd-4204-baaa-a4634ae65ab33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71785-1006-07178510060030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71785-1006-0) 2019-07-080000-00-00NoNoCurrent
71785-1006-17178510060190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71785-1006-1) 2019-07-080000-00-00NoNoCurrent
71785-1006-271785100602500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71785-1006-2) 2019-07-080000-00-00NoNoCurrent
71785-1006-37178510060310 BLISTER PACK in 1 CARTON (71785-1006-3) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2019-07-080000-00-00NoNoCurrent