FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
65862-697
11-digit product format
658620697
Labeler code
65862
Product ID
65862-697_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
2011-11-23
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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 HYDROCHLORIDE150 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
65862-697-01Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10026
65862-697-05Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50026
65862-697-10Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE1026
65862-697-10Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE1026
65862-697-26Venlafaxine Hydrochloride2500 in 1 BOTTLECAPSULE, EXTENDED RELEASE250026
65862-697-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3026
65862-697-47Venlafaxine Hydrochloride15 in 1 BOTTLECAPSULE, EXTENDED RELEASE1526
65862-697-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-697-01EA - Each65862-697d2180662-7f31-44ac-891e-e82623a1403e12012-07-24
65862-697-05EA - Each65862-697b605f18e-5098-494d-8cfb-e14dd064845712012-07-24
65862-697-30EA - Each65862-6977c290ec9-6828-4e43-8276-fe490eea63fb12012-07-24
65862-697-90EA - Each65862-697dbb8a789-4be5-4bc5-a8eb-31dbf6d51b0512012-07-24

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
65862-697VENLAFAXINE 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
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
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN50d3b487-9f65-4e2f-b6eb-9533964f897215
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD50d3b487-9f65-4e2f-b6eb-9533964f897215
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY50d3b487-9f65-4e2f-b6eb-9533964f897215
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
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN04340ccb-c3b3-41ab-a4bc-101d8b6bc1a95
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD04340ccb-c3b3-41ab-a4bc-101d8b6bc1a95
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY04340ccb-c3b3-41ab-a4bc-101d8b6bc1a95
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN8f9d3d30-e9a6-6c85-e053-2a95a90a55243
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNc69d16fd-b82d-4708-aece-ab4f60b29cc63
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb3
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNc69d16fd-b82d-4708-aece-ab4f60b29cc63
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNc69d16fd-b82d-4708-aece-ab4f60b29cc63
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD8f9d3d30-e9a6-6c85-e053-2a95a90a55243
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDc69d16fd-b82d-4708-aece-ab4f60b29cc63
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb3
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
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb3
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYc69d16fd-b82d-4708-aece-ab4f60b29cc63
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY8f9d3d30-e9a6-6c85-e053-2a95a90a55243
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 CapsuleSYc69d16fd-b82d-4708-aece-ab4f60b29cc63
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNf8fd4381-52f2-d9c1-e053-6394a90a08e52
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNe2d5a2d5-5e55-426c-bc8d-d29729eba7752
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDf8fd4381-52f2-d9c1-e053-6394a90a08e52
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDe2d5a2d5-5e55-426c-bc8d-d29729eba7752
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYe2d5a2d5-5e55-426c-bc8d-d29729eba7752
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYf8fd4381-52f2-d9c1-e053-6394a90a08e52
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN33068acd-d361-4cd9-b994-02a7865ff04f1
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN5c558ab8-b4b3-4973-b016-ed5cfcb4d88b1
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN9b8e27ef-e460-604f-e053-2a95a90a7bbf1
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNb0605e82-ed83-a82e-e053-2995a90a55371
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNf8dfd8cf-6f82-45b3-934e-01a89e6215231
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNb0605e82-ed83-a82e-e053-2995a90a55371
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDf8dfd8cf-6f82-45b3-934e-01a89e6215231
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDd962f5af-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 CapsuleSCD33068acd-d361-4cd9-b994-02a7865ff04f1
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD9b8e27ef-e460-604f-e053-2a95a90a7bbf1
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD5c558ab8-b4b3-4973-b016-ed5cfcb4d88b1
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDd962f5af-7642-4c6e-b7be-3e089fe488731
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDb0605e82-ed83-a82e-e053-2995a90a55371
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDd962f5af-7642-4c6e-b7be-3e089fe488731
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY9b8e27ef-e460-604f-e053-2a95a90a7bbf1
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY5c558ab8-b4b3-4973-b016-ed5cfcb4d88b1
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY33068acd-d361-4cd9-b994-02a7865ff04f1
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYd962f5af-7642-4c6e-b7be-3e089fe488731
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYf8dfd8cf-6f82-45b3-934e-01a89e6215231
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYb0605e82-ed83-a82e-e053-2995a90a55371
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYd962f5af-7642-4c6e-b7be-3e089fe488731
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYb0605e82-ed83-a82e-e053-2995a90a55371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-697-0165862069701100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-697-01) 2011-11-230000-00-00NoNoCurrent
65862-697-0565862069705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-697-05) 2011-11-230000-00-00NoNoCurrent
65862-697-106586206971010 BLISTER PACK in 1 CARTON (65862-697-10) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2011-11-230000-00-00NoNoCurrent
65862-697-22658620697222000 CAPSULE, EXTENDED RELEASE in 1 BAG (65862-697-22)23-NOV-11Current
65862-697-26658620697262500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-697-26) 2011-11-230000-00-00NoNoCurrent
65862-697-306586206973030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-697-30) 2011-11-230000-00-00NoNoCurrent
65862-697-476586206974715 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-697-47) 2011-11-230000-00-00NoNoCurrent
65862-697-906586206979090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-697-90) 2011-11-230000-00-00NoNoCurrent