Hydrocortisone Butyrate

Product NDC
68462-464
11-digit product format
684620464
Labeler code
68462
Product ID
68462-464_e1464cd5-9559-4d41-a6ca-0cc4f9869823
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone Butyrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA202145
Marketing category
ANDA
Marketing start
2013-12-05
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
1 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
68462-464-47GM - Gram68462-4649089260b-6af2-4bb3-a2e1-4e15cda1476b12014-01-04
68462-464-65GM - Gram68462-464d525cec2-970e-413b-bd15-483a90666a2012014-01-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-464-176846204641715 g in 1 CARTON (68462-464-17) 15 g2013-12-050000-00-00NoNoCurrent
68462-464-476846204644745 g in 1 CARTON (68462-464-47) 45 g2013-12-050000-00-00NoNoCurrent
68462-464-656846204646560 g in 1 CARTON (68462-464-65) 60 g2013-12-050000-00-00NoNoCurrent