Temovate

Product NDC
10337-163
11-digit product format
103370163
Labeler code
10337
Product ID
10337-163_17dbbb71-8c20-449c-aa10-67b7d40aee18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application
ANDA074392
Marketing category
ANDA
Marketing start
1996-09-30
Marketing end
2022-06-30
Substance
CLOBETASOL 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10337-163-30GM - Gram10337-163c2d0ff69-659b-4203-b93b-c60c5e09eb9e12013-10-17
10337-163-60GM - Gram10337-163ece30a51-0252-4ab8-8615-0047e1cb247612013-03-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10337-163-30103370163301 TUBE in 1 CARTON (10337-163-30) > 30 g in 1 TUBE1 tube1996-09-302022-06-30NoNoCurrent
10337-163-60103370163601 TUBE in 1 CARTON (10337-163-60) > 60 g in 1 TUBE1 tube1996-09-300000-00-00NoNoCurrent