Hydrocortisone valerate

Product NDC
68462-575
11-digit product format
684620575
Labeler code
68462
Product ID
68462-575_5aeb448b-0f5f-4a92-be7c-a7f74bb57d9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
Glenamrk Pharmaceuticals Inc., USA
Application
ANDA211129
Marketing category
ANDA
Marketing start
2018-10-15
Marketing end
0000-00-00
Substance
HYDROCORTISONE VALERATE
Active strength
2 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-575-17GM - Gram68462-575c3a51626-bb7b-495f-8f75-e37f202cdc2912019-01-24
68462-575-47GM - Gram68462-575a9b214ac-9a61-43f5-b02a-e1c931e31a8712019-01-24
68462-575-65GM - Gram68462-575b2fb7bcb-ea29-49b6-a04a-3b2e8adf741112019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-575-176846205751715 g in 1 TUBE (68462-575-17) 15 g2018-10-150000-00-00NoNoCurrent
68462-575-476846205754745 g in 1 TUBE (68462-575-47) 45 g2018-10-150000-00-00NoNoCurrent
68462-575-656846205756560 g in 1 TUBE (68462-575-65) 60 g2018-10-150000-00-00NoNoCurrent