Home NDC 58980-780 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded product product U Excluded because listing certification expired 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58980-780-21 U Excluded because listing certification expired 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58980-780-21 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58980-780-21 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58980-780-21 I Inactivated by FDA 110d247fa046…a55b01930146…
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58980-780 VENELEX () [STRATUS PHARMACEUTICALS INC] 6 Legacy NDC, 6 package rows 20231205_13291e03-6f75-403b-afc4-c44a10ca0083.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 58980-780-11 58980078011 1 in 1 BOX Historical 58980-780-21 58980078021 60 g in 1 TUBE 60 g Historical 58980-780-50 58980078050 1 in 1 BOX, UNIT-DOSE Historical