Androgel

Product NDC
0051-8462
11-digit product format
000518462
Labeler code
0051
Product ID
0051-8462_d34e7ee8-3f6b-4473-8e1b-f3a90467fb6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
AbbVie Inc.
Application
NDA022309
Marketing category
NDA
Marketing start
2011-04-29
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
0051-8462-01GM - Gram0051-8462bcffc0fb-dbc3-4ac3-9d18-ea28f1e84d0a12015-07-20
0051-8462-12GM - Gram0051-84627bc2653a-b166-4fa9-b114-e50dac65080a12015-07-20
0051-8462-30GM - Gram0051-846261aa5033-bcd4-4f54-9916-7cb144c2d3a612013-02-13
0051-8462-31GM - Gram0051-84627efc9065-8734-46b2-a66c-3e8d7cbfad0812013-02-13
0051-8462-33GM - Gram0051-8462d64c8784-bd5d-4d35-8e79-99bab638f33512012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0051-8462-300005184623030 PACKET in 1 CARTON (0051-8462-30) > 2.5 g in 1 PACKET (0051-8462-01) 30 packet2011-04-290000-00-00NoNoCurrent
0051-8462-310005184623130 PACKET in 1 CARTON (0051-8462-31) > 1.25 g in 1 PACKET (0051-8462-12) 30 packet2011-04-290000-00-00NoNoCurrent
0051-8462-33000518462331 BOTTLE, PUMP in 1 CARTON (0051-8462-33) > 88 g in 1 BOTTLE, PUMP2011-04-290000-00-00NoNoCurrent