FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
31722-004
11-digit product format
317220004
Labeler code
31722
Product ID
31722-004_1eee52e9-dda9-0d36-e063-6394a90a905b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA212277
Marketing category
ANDA
Marketing start
2019-07-08
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
31722-004-01Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE103
31722-004-01Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE103
31722-004-05Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5003
31722-004-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
31722-004-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-004-30EA - Each31722-004f08fbac1-e4aa-4d70-b1da-f58c12fdcbdc12020-09-14
31722-004-90EA - Each31722-0044031b9c0-01c8-4d00-a33a-7794f7ef841812020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-004VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 5 package rows20240806_0ee91447-2c23-4519-81cc-550b5416dd6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN1e1119f7-0c2e-4587-a24d-0066f73b2e65103
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD1e1119f7-0c2e-4587-a24d-0066f73b2e65103
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY1e1119f7-0c2e-4587-a24d-0066f73b2e65103
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNd8e00b3d-29de-1de5-e053-2995a90acb515
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNb18d726e-cdb2-4c80-a49d-330cddee17e95
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDd8e00b3d-29de-1de5-e053-2995a90acb515
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDb18d726e-cdb2-4c80-a49d-330cddee17e95
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYd8e00b3d-29de-1de5-e053-2995a90acb515
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYb18d726e-cdb2-4c80-a49d-330cddee17e95
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN0ee91447-2c23-4519-81cc-550b5416dd6b3
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNdf7e0982-3eb0-4bdf-8f7f-4f4a48476ed73
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN0ee91447-2c23-4519-81cc-550b5416dd6b3
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN0ee91447-2c23-4519-81cc-550b5416dd6b3
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDdf7e0982-3eb0-4bdf-8f7f-4f4a48476ed73
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD0ee91447-2c23-4519-81cc-550b5416dd6b3
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD0ee91447-2c23-4519-81cc-550b5416dd6b3
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD0ee91447-2c23-4519-81cc-550b5416dd6b3
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY0ee91447-2c23-4519-81cc-550b5416dd6b3
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYdf7e0982-3eb0-4bdf-8f7f-4f4a48476ed73
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY0ee91447-2c23-4519-81cc-550b5416dd6b3
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY0ee91447-2c23-4519-81cc-550b5416dd6b3
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN2efde38c-250e-d1b9-e063-6394a90a1b741
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN2efde38c-250e-d1b9-e063-6394a90a1b741
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN2efde38c-250e-d1b9-e063-6394a90a1b741
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD2efde38c-250e-d1b9-e063-6394a90a1b741
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD2efde38c-250e-d1b9-e063-6394a90a1b741
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD2efde38c-250e-d1b9-e063-6394a90a1b741
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY2efde38c-250e-d1b9-e063-6394a90a1b741
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY2efde38c-250e-d1b9-e063-6394a90a1b741
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY2efde38c-250e-d1b9-e063-6394a90a1b741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-004-013172200040110 BLISTER PACK in 1 CARTON (31722-004-01) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2019-07-080000-00-00NoNoCurrent
31722-004-0531722000405500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-004-05) 2019-07-080000-00-00NoNoCurrent
31722-004-303172200043030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-004-30) 2019-07-080000-00-00NoNoCurrent
31722-004-903172200049090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-004-90) 2019-07-080000-00-00NoNoCurrent