Hydrocortisone Butyrate

Product NDC
68788-7719
11-digit product format
687887719
Labeler code
68788
Product ID
68788-7719_55bea2ee-f02a-48fb-9327-2dadcda66bc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone Butyrate Lotion
Dosage form
LOTION
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA209556
Marketing category
ANDA
Marketing start
2020-07-01
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7719-1687887719011 TUBE in 1 CARTON (68788-7719-1) > 118 mL in 1 TUBE1 tube2020-07-010000-00-00NoNoCurrent