FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
31722-003
11-digit product format
317220003
Labeler code
31722
Product ID
31722-003_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
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
31722-003-01Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE103
31722-003-01Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE103
31722-003-05Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5003
31722-003-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
31722-003-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-003-30EA - Each31722-00367fb0570-0ce6-4b37-aee2-2d2eeb52ec8212020-09-14
31722-003-90EA - Each31722-00318a0bb9b-61a3-4504-a1c8-bad319776eb012020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-003VENLAFAXINE 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
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN20a7d922-7f7c-4de4-b5fd-55c13aab060c102
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD20a7d922-7f7c-4de4-b5fd-55c13aab060c102
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY20a7d922-7f7c-4de4-b5fd-55c13aab060c102
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN653f3f95-98d0-4ce0-bf10-ac7938be690e5
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD653f3f95-98d0-4ce0-bf10-ac7938be690e5
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY653f3f95-98d0-4ce0-bf10-ac7938be690e5
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN0ee91447-2c23-4519-81cc-550b5416dd6b3
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
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNc41d847b-88ba-49a5-9d73-269ac4caa4ed3
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
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDc41d847b-88ba-49a5-9d73-269ac4caa4ed3
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY0ee91447-2c23-4519-81cc-550b5416dd6b3
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
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYc41d847b-88ba-49a5-9d73-269ac4caa4ed3
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNd22dd735-c1d6-4816-e053-2a95a90aecad2
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDd22dd735-c1d6-4816-e053-2a95a90aecad2
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYd22dd735-c1d6-4816-e053-2a95a90aecad2
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
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN2c2bb0e6-5a73-ff57-e063-6294a90a88d31
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNdf741f04-153e-ae88-e053-2a95a90abeea1
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
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD2c2bb0e6-5a73-ff57-e063-6294a90a88d31
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDdf741f04-153e-ae88-e053-2a95a90abeea1
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
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY2c2bb0e6-5a73-ff57-e063-6294a90a88d31
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYdf741f04-153e-ae88-e053-2a95a90abeea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-003-013172200030110 BLISTER PACK in 1 CARTON (31722-003-01) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2019-07-080000-00-00NoNoCurrent
31722-003-0531722000305500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-003-05) 2019-07-080000-00-00NoNoCurrent
31722-003-303172200033030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-003-30) 2019-07-080000-00-00NoNoCurrent
31722-003-903172200039090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-003-90) 2019-07-080000-00-00NoNoCurrent