HYDROCORTISONE BUTYRATE

Product NDC
51862-159
11-digit product format
518620159
Labeler code
51862
Product ID
51862-159_5cc0fa38-756a-4fe1-9e2e-789273ed8014
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE BUTYRATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Mayne Pharma Inc.
Application
ANDA209556
Marketing category
ANDA
Marketing start
2019-11-29
Marketing end
0000-00-00
Substance
HYDROCORTISONE BUTYRATE
Active strength
1 mg/mL
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
51862-159-04ML - Milliliter51862-1599ae21a7c-f6f5-4d20-9145-58bd9a70ace012019-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-159-04518620159041 BOTTLE in 1 CARTON (51862-159-04) > 118 mL in 1 BOTTLE1 bottle2019-11-290000-00-00NoNoCurrent