FORTESTA

Product NDC
63481-183
11-digit product format
634810183
Labeler code
63481
Product ID
63481-183_e7e72195-64db-49c5-b94f-b7b1342a2dbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
GEL, METERED
Route
TOPICAL
Labeler
Endo Pharmaceuticals Inc.
Application
NDA021463
Marketing category
NDA
Marketing start
2010-12-29
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
10 mg/.5g
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63481-183-16GM - Gram63481-18399b1d457-e7cd-414e-9741-dd1ba7befa0512012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63481-183-16634810183161 CANISTER in 1 CARTON (63481-183-16) > 60 g in 1 CANISTER1 canister2010-12-290000-00-00NoNoCurrent
63481-183-17634810183172 CANISTER in 1 CARTON (63481-183-17) > 60 g in 1 CANISTER2 canister2010-12-290000-00-00NoNoCurrent
63481-183-18634810183183 CANISTER in 1 CARTON (63481-183-18) > 60 g in 1 CANISTER3 canister2010-12-290000-00-00NoNoCurrent