FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
65862-528
11-digit product format
658620528
Labeler code
65862
Product ID
65862-528_d3f9b554-05be-484f-b9e7-5c8e6b2de9c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA200834
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
65862-528-01Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10026
65862-528-10Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE1026
65862-528-10Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE1026
65862-528-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3026
65862-528-35Venlafaxine Hydrochloride3500 in 1 BOTTLECAPSULE, EXTENDED RELEASE350026
65862-528-47Venlafaxine Hydrochloride15 in 1 BOTTLECAPSULE, EXTENDED RELEASE1526
65862-528-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9026
65862-528-99Venlafaxine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-528VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]26Current NDC, Legacy NDC, 8 package rows20240509_85d3ce8b-8966-45d9-bdaf-f6f0475096e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN1a9e207a-aba5-4ecb-b7b6-7c1e38be5ac9102
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD1a9e207a-aba5-4ecb-b7b6-7c1e38be5ac9102
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY1a9e207a-aba5-4ecb-b7b6-7c1e38be5ac9102
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN7852be9e-0c1d-47a8-9513-c3a04b36576333
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN7852be9e-0c1d-47a8-9513-c3a04b36576333
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN7852be9e-0c1d-47a8-9513-c3a04b36576333
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD7852be9e-0c1d-47a8-9513-c3a04b36576333
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD7852be9e-0c1d-47a8-9513-c3a04b36576333
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD7852be9e-0c1d-47a8-9513-c3a04b36576333
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY7852be9e-0c1d-47a8-9513-c3a04b36576333
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY7852be9e-0c1d-47a8-9513-c3a04b36576333
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY7852be9e-0c1d-47a8-9513-c3a04b36576333
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN85d3ce8b-8966-45d9-bdaf-f6f0475096e126
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN85d3ce8b-8966-45d9-bdaf-f6f0475096e126
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN85d3ce8b-8966-45d9-bdaf-f6f0475096e126
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD85d3ce8b-8966-45d9-bdaf-f6f0475096e126
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD85d3ce8b-8966-45d9-bdaf-f6f0475096e126
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD85d3ce8b-8966-45d9-bdaf-f6f0475096e126
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY85d3ce8b-8966-45d9-bdaf-f6f0475096e126
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY85d3ce8b-8966-45d9-bdaf-f6f0475096e126
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY85d3ce8b-8966-45d9-bdaf-f6f0475096e126
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNac9b972d-8b8a-4727-90c2-b208f91272fd17
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDac9b972d-8b8a-4727-90c2-b208f91272fd17
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYac9b972d-8b8a-4727-90c2-b208f91272fd17
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNe05bdeb4-07a9-441e-901b-f2aea550db2b12
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNe05bdeb4-07a9-441e-901b-f2aea550db2b12
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNe05bdeb4-07a9-441e-901b-f2aea550db2b12
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDe05bdeb4-07a9-441e-901b-f2aea550db2b12
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDe05bdeb4-07a9-441e-901b-f2aea550db2b12
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDe05bdeb4-07a9-441e-901b-f2aea550db2b12
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYe05bdeb4-07a9-441e-901b-f2aea550db2b12
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYe05bdeb4-07a9-441e-901b-f2aea550db2b12
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYe05bdeb4-07a9-441e-901b-f2aea550db2b12
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNf32ca617-66e0-41d8-e053-2a95a90ae40a5
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDf32ca617-66e0-41d8-e053-2a95a90ae40a5
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYf32ca617-66e0-41d8-e053-2a95a90ae40a5
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN22980b32-cbae-4f37-9fc0-b47221b2c32e4
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN8906ed5a-f69c-0eac-e053-2995a90ae6004
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD22980b32-cbae-4f37-9fc0-b47221b2c32e4
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD8906ed5a-f69c-0eac-e053-2995a90ae6004
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY8906ed5a-f69c-0eac-e053-2995a90ae6004
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY22980b32-cbae-4f37-9fc0-b47221b2c32e4
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNc69d16fd-b82d-4708-aece-ab4f60b29cc63
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNc69d16fd-b82d-4708-aece-ab4f60b29cc63
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNf757cac4-efa7-668c-e053-6294a90a720d3
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNc69d16fd-b82d-4708-aece-ab4f60b29cc63
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN28c8f404-1dbd-4140-8959-32624d7c77243
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDc69d16fd-b82d-4708-aece-ab4f60b29cc63
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDc69d16fd-b82d-4708-aece-ab4f60b29cc63
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDc69d16fd-b82d-4708-aece-ab4f60b29cc63
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDf757cac4-efa7-668c-e053-6294a90a720d3
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD28c8f404-1dbd-4140-8959-32624d7c77243
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYc69d16fd-b82d-4708-aece-ab4f60b29cc63
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYc69d16fd-b82d-4708-aece-ab4f60b29cc63
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY28c8f404-1dbd-4140-8959-32624d7c77243
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYf757cac4-efa7-668c-e053-6294a90a720d3
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYc69d16fd-b82d-4708-aece-ab4f60b29cc63
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNf89bcae0-e714-599a-e053-6294a90a2c3a2
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN18e77a42-6552-4042-9ed3-046c94f4f9212
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDf89bcae0-e714-599a-e053-6294a90a2c3a2
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD18e77a42-6552-4042-9ed3-046c94f4f9212
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY18e77a42-6552-4042-9ed3-046c94f4f9212
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYf89bcae0-e714-599a-e053-6294a90a2c3a2
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNb0605e82-ed83-a82e-e053-2995a90a55371
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN569e10d1-6432-473c-a026-ac438bd77bcd1
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN9128aa8c-3e0e-4b09-a67b-ac453bd330c41
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNe1114c1d-c193-4c0c-ad1c-c17b3fc617231
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNb0605e82-ed83-a82e-e053-2995a90a55371
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNdd4201bf-c845-4888-ada8-8506f04b89d81
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN4992698e-5d5a-6468-e063-6394a90ab4041
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN3cbe3e18-9a7e-aaa3-e063-6394a90abf921
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDb0605e82-ed83-a82e-e053-2995a90a55371
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDd962f5af-7642-4c6e-b7be-3e089fe488731
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDd962f5af-7642-4c6e-b7be-3e089fe488731
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD4992698e-5d5a-6468-e063-6394a90ab4041
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD569e10d1-6432-473c-a026-ac438bd77bcd1
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDe1114c1d-c193-4c0c-ad1c-c17b3fc617231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-528-0165862052801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-01) 2011-06-010000-00-00NoNoCurrent
65862-528-106586205281010 BLISTER PACK in 1 CARTON (65862-528-10) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2011-06-010000-00-00NoNoCurrent
65862-528-26658620528262500 CAPSULE, EXTENDED RELEASE in 1 BAG (65862-528-26)01-JUN-11Current
65862-528-306586205283030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-30) 2011-06-010000-00-00NoNoCurrent
65862-528-35658620528353500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-35) 2011-06-010000-00-00NoNoCurrent
65862-528-476586205284715 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-47) 2011-06-010000-00-00NoNoCurrent
65862-528-906586205289090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-90) 2011-06-010000-00-00NoNoCurrent
65862-528-99658620528991000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-99) 2011-06-010000-00-00NoNoCurrent