Testosterone Gel, 1%

Product NDC
63629-9585
11-digit product format
636299585
Labeler code
63629
Product ID
63629-9585_431f2447-ef1d-4d4a-9091-8e979b74571e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Gel, 1%
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Bryant Ranch Prepack
Application
ANDA212984
Marketing category
ANDA
Marketing start
2021-11-19
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
10 mg/g
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
63629-9585-1GM - Gram63629-9585186ed411-4e1c-40f2-84b1-6d5a89c438ed12023-02-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9585-16362995850130 PACKET in 1 CARTON (63629-9585-1) > 5 g in 1 PACKET30 packet2022-12-120000-00-00NoNoCurrent