Venelex

Product NDC
58980-780
11-digit product format
589800780
Labeler code
58980
Product ID
58980-780_ae718f2b-8848-4f0c-b556-1561a3524c8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Castor Oil and Balsam, Peru
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Stratus Pharamceuticals, Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-11-29
Marketing end
0000-00-00
Substance
CASTOR OIL; BALSAM, PERU
Active strength
788 mg/g; mg/g
Pharmacologic classes
Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58980-780-212021-12-08C16284748780-1956f9ecf-cace-621f-e053-dbdaa90a74adVENELEX™ OINTMENT
58980-780-212019-10-21C16284748780-1956f9ecf-cace-621f-e053-dbdaa90a74adVENELEX™ OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-780-11VENELEX1 in 1 BOX16
58980-780-11VENELEX30 g in 1 TUBE306
58980-780-21VENELEX60 g in 1 TUBE606
58980-780-21VENELEX1 in 1 BOX16
58980-780-50VENELEX1 in 1 BOX, UNIT-DOSE16
58980-780-50VENELEX5 g in 1 PACKET56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-780-11GM - Gram58980-78069f789b5-56dd-4be3-8ba0-789dedb95f8c12015-08-04
58980-780-21GM - Gram58980-7802a15939d-9d50-4180-b649-62331a37475912012-07-24
58980-780-50GM - Gram58980-7809626c6ef-7acb-4086-870d-4d8e698cbe3412015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Balsam PeruACTIVE INGREDIENT8P5F881OCYVENELEX () [STRATUS PHARMACEUTICALS]2
Castor OilACTIVE INGREDIENTD5340Y2I9GVENELEX () [STRATUS PHARMACEUTICALS]2
Balsam PeruACTIVE MOIETY8P5F881OCYVENELEX () [STRATUS PHARMACEUTICALS]2
Castor OilACTIVE MOIETYD5340Y2I9GVENELEX () [STRATUS PHARMACEUTICALS]2
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4VENELEX () [STRATUS PHARMACEUTICALS]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UVENELEX () [STRATUS PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-780VENELEX () [STRATUS PHARMACEUTICALS INC]6Legacy NDC, 6 package rows20231205_13291e03-6f75-403b-afc4-c44a10ca0083.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58980-780-11589800780111 in 1 BOXHistorical
58980-780-215898007802160 g in 1 TUBE60 gHistorical
58980-780-50589800780501 in 1 BOX, UNIT-DOSEHistorical