Halobetasol Propionate

Product NDC
0713-0758
11-digit product format
007130758
Labeler code
0713
Product ID
0713-0758_dde31435-a635-4f8a-e053-2a95a90a6fd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA077109
Marketing category
ANDA
Marketing start
2019-05-21
Marketing end
2023-07-31
Substance
HALOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0758-15GM - Gram0713-0758a3d6df75-7e74-4fcf-bf7f-17d888a54e6712019-08-06
0713-0758-86GM - Gram0713-0758395885bf-7e0e-48c8-9431-d9b2add1188b12019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0758-15007130758151 TUBE in 1 CARTON (0713-0758-15) > 15 g in 1 TUBE1 tube2019-05-210000-00-00NoNoCurrent
0713-0758-86007130758861 TUBE in 1 CARTON (0713-0758-86) > 50 g in 1 TUBE1 tube2019-05-210000-00-00NoNoCurrent