FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
31722-002
11-digit product format
317220002
Labeler code
31722
Product ID
31722-002_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
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
31722-002-01Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE103
31722-002-01Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE103
31722-002-05Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5003
31722-002-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
31722-002-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-002-30EA - Each31722-00232d6fd45-df70-48d2-ab6d-27ef02b9147412020-09-14
31722-002-90EA - Each31722-0028214c1bd-7b9e-4cd3-9b8e-ccb3ec89252312020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-002VENLAFAXINE 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
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNbaae24d6-e425-4cfc-9a53-3cd223b6d344102
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDbaae24d6-e425-4cfc-9a53-3cd223b6d344102
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYbaae24d6-e425-4cfc-9a53-3cd223b6d344102
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN52319578-f7cc-4b87-b532-f341854e40b47
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD52319578-f7cc-4b87-b532-f341854e40b47
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY52319578-f7cc-4b87-b532-f341854e40b47
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN6c1d0d4f-c8e2-4035-8f4e-7a46bfe3f0595
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD6c1d0d4f-c8e2-4035-8f4e-7a46bfe3f0595
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY6c1d0d4f-c8e2-4035-8f4e-7a46bfe3f0595
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN0ee91447-2c23-4519-81cc-550b5416dd6b3
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNc0fa9a3b-692e-2c2e-e053-2995a90aa83a3
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 CapsuleSCD0ee91447-2c23-4519-81cc-550b5416dd6b3
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDc0fa9a3b-692e-2c2e-e053-2995a90aa83a3
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
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY0ee91447-2c23-4519-81cc-550b5416dd6b3
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYc0fa9a3b-692e-2c2e-e053-2995a90aa83a3
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
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN922388b3-fc1c-46c6-b314-9049bd042df71
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
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD922388b3-fc1c-46c6-b314-9049bd042df71
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
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY922388b3-fc1c-46c6-b314-9049bd042df71
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
31722-002-013172200020110 BLISTER PACK in 1 CARTON (31722-002-01) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2019-07-080000-00-00NoNoCurrent
31722-002-0531722000205500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-002-05) 2019-07-080000-00-00NoNoCurrent
31722-002-303172200023030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-002-30) 2019-07-080000-00-00NoNoCurrent
31722-002-903172200029090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-002-90) 2019-07-080000-00-00NoNoCurrent