Testosterone

Product NDC
68382-362
11-digit product format
683820362
Labeler code
68382
Product ID
68382-362_8666360e-663b-404a-ad04-d82f88b33fb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Zydus Pharmaceuticals USA Inc
Application
NDA022309
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-10-12
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
16 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
68382-362-11GM - Gram68382-3624a3cd9a6-b2cd-4fdc-872f-44dc791f8b3a12018-11-06
68382-362-12GM - Gram68382-362b839d9ae-1357-438f-8eeb-25c6035ac6da12018-11-06
68382-362-13GM - Gram68382-3626e168ee2-bbba-4f94-befd-57ab0f3d392112018-11-06
68382-362-14GM - Gram68382-3623d7e2521-3165-4cc9-be86-eb81f81376bb12018-11-06
68382-362-15GM - Gram68382-362493b1950-3cbf-4704-9347-a719329be0c212018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-362-11683820362111 BOTTLE, PUMP in 1 CARTON (68382-362-11) > 88 g in 1 BOTTLE, PUMP2018-10-120000-00-00NoNoCurrent
68382-362-146838203621430 PACKET in 1 CARTON (68382-362-14) > 1.25 g in 1 PACKET (68382-362-12) 30 packet2018-10-120000-00-00NoNoCurrent
68382-362-156838203621530 PACKET in 1 CARTON (68382-362-15) > 2.5 g in 1 PACKET (68382-362-13) 30 packet2018-10-120000-00-00NoNoCurrent