FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
65862-527
11-digit product format
658620527
Labeler code
65862
Product ID
65862-527_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
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
65862-527-01Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10026
65862-527-10Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE1026
65862-527-10Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE1026
65862-527-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3026
65862-527-47Venlafaxine Hydrochloride15 in 1 BOTTLECAPSULE, EXTENDED RELEASE1526
65862-527-59Venlafaxine Hydrochloride5000 in 1 BOTTLECAPSULE, EXTENDED RELEASE500026
65862-527-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9026
65862-527-99Venlafaxine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-527-01EA - Each65862-5275488da01-d1a2-4cd2-a84b-9f443b2b374a12012-07-24
65862-527-30EA - Each65862-527598cee8a-4a6e-4663-95ed-8be3ba7b348f12012-07-24
65862-527-90EA - Each65862-527de27e4b6-6631-47cd-a68b-e99c16cc186f12012-07-24
65862-527-99EA - Each65862-5275fc529df-712b-411c-a077-307305abd73012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
ETHYLCELLULOSE (20 MPA.S)INACTIVE INGREDIENTBJG0S321QYVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
SHELLACINACTIVE INGREDIENT46N107B71OVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
SUCROSEINACTIVE INGREDIENTC151H8M554VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]10
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
ETHYLCELLULOSE (20 MPA.S)INACTIVE INGREDIENTBJG0S321QYVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SHELLACINACTIVE INGREDIENT46N107B71OVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SUCROSEINACTIVE INGREDIENTC151H8M554VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-527VENLAFAXINE 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
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNbff505db-2752-41fc-a4dd-4773f629106e104
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDbff505db-2752-41fc-a4dd-4773f629106e104
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYbff505db-2752-41fc-a4dd-4773f629106e104
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
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN4e3053b9-cdec-4f4d-85ae-2e55cf1cc18515
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD4e3053b9-cdec-4f4d-85ae-2e55cf1cc18515
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY4e3053b9-cdec-4f4d-85ae-2e55cf1cc18515
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
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN0c404290-2806-4756-bca3-2d639b4009635
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD0c404290-2806-4756-bca3-2d639b4009635
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY0c404290-2806-4756-bca3-2d639b4009635
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNe20b7d9e-f755-4325-e053-2995a90ac45d4
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDe20b7d9e-f755-4325-e053-2995a90ac45d4
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYe20b7d9e-f755-4325-e053-2995a90ac45d4
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
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN9d38eac0-9d64-1274-e053-2995a90a189a3
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNc69d16fd-b82d-4708-aece-ab4f60b29cc63
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
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD9d38eac0-9d64-1274-e053-2995a90a189a3
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDc69d16fd-b82d-4708-aece-ab4f60b29cc63
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
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY9d38eac0-9d64-1274-e053-2995a90a189a3
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYc69d16fd-b82d-4708-aece-ab4f60b29cc63
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNaaa14e95-904e-45c6-be4d-c94167b203002
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDaaa14e95-904e-45c6-be4d-c94167b203002
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYaaa14e95-904e-45c6-be4d-c94167b203002
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN35d3148b-52f3-197c-e063-6294a90a44e31
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN4d02b6ce-8a0c-411b-853f-ef78f4bbef7d1
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN812ca864-8230-4c84-a7f4-d1b926dee31a1
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDd962f5af-7642-4c6e-b7be-3e089fe488731
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD4d02b6ce-8a0c-411b-853f-ef78f4bbef7d1
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD35d3148b-52f3-197c-e063-6294a90a44e31
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD812ca864-8230-4c84-a7f4-d1b926dee31a1
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDd962f5af-7642-4c6e-b7be-3e089fe488731
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDd962f5af-7642-4c6e-b7be-3e089fe488731
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYd962f5af-7642-4c6e-b7be-3e089fe488731
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY812ca864-8230-4c84-a7f4-d1b926dee31a1
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYd962f5af-7642-4c6e-b7be-3e089fe488731
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY4d02b6ce-8a0c-411b-853f-ef78f4bbef7d1
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY35d3148b-52f3-197c-e063-6294a90a44e31
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYd962f5af-7642-4c6e-b7be-3e089fe488731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-527-0165862052701100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-527-01) 2011-06-010000-00-00NoNoCurrent
65862-527-106586205271010 BLISTER PACK in 1 CARTON (65862-527-10) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2011-06-010000-00-00NoNoCurrent
65862-527-306586205273030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-527-30) 2011-06-010000-00-00NoNoCurrent
65862-527-476586205274715 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-527-47) 2011-06-010000-00-00NoNoCurrent
65862-527-59658620527595000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-527-59) 2011-06-010000-00-00NoNoCurrent
65862-527-906586205279090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-527-90) 2011-06-010000-00-00NoNoCurrent
65862-527-99658620527991000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-527-99) 2011-06-010000-00-00NoNoCurrent