NDC Code(s) : 0245-0880-89, 0245-0880-30, 0245-0880-66, 0245-0881-89, 0245-0881-30, 0245-0881-66, 0245-0882-89, 0245-0882-30, 0245-0882-66
Packager : Upsher-Smith Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DivigelEstradiol GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0880
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Estradiol(UNII: 4TI98Z838E)
(Estradiol - UNII:4TI98Z838E) 		Estradiol0.25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
carbomer homopolymer type b/c (allyl pentaerythritol crosslinked)(UNII: 4Q93RCW27E)
alcohol(UNII: 3K9958V90M)
Propylene glycol(UNII: 6DC9Q167V3)
water(UNII: 059QF0KO0R)
Trolamine(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0245-0880-890.25 g in 1 PACKET
2NDC:0245-0880-3030 in 1 CARTON
20.25 g in 1 PACKET
3NDC:0245-0880-667 in 1 CARTON
30.25 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022038 02/28/2011
DivigelEstradiol GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0881
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Estradiol(UNII: 4TI98Z838E)
(Estradiol - UNII:4TI98Z838E) 		Estradiol0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
carbomer homopolymer type b/c (allyl pentaerythritol crosslinked)(UNII: 4Q93RCW27E)
alcohol(UNII: 3K9958V90M)
Propylene glycol(UNII: 6DC9Q167V3)
water(UNII: 059QF0KO0R)
Trolamine(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0245-0881-890.5 g in 1 PACKET
2NDC:0245-0881-3030 in 1 CARTON
20.5 g in 1 PACKET
3NDC:0245-0881-667 in 1 CARTON
30.5 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022038 02/28/2011
DivigelEstradiol GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0882
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Estradiol(UNII: 4TI98Z838E)
(Estradiol - UNII:4TI98Z838E) 		Estradiol1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
carbomer homopolymer type b/c (allyl pentaerythritol crosslinked)(UNII: 4Q93RCW27E)
alcohol(UNII: 3K9958V90M)
Propylene glycol(UNII: 6DC9Q167V3)
water(UNII: 059QF0KO0R)
Trolamine(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0245-0882-891 g in 1 PACKET
2NDC:0245-0882-3030 in 1 CARTON
21 g in 1 PACKET
3NDC:0245-0882-667 in 1 CARTON
31 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022038 02/28/2011

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 0.25 mg Packet Carton

PROFESSIONAL SAMPLE: Not for Sale
NDC 0245-0880-66

Divigel ®
(estradiol gel)
0.1%

0.25 mg
Rx only

7 packets
0.25 g gel provides 0.25 mg estradiol/packet

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 0.25 mg Packet Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 0.5 mg Packet Carton

PROFESSIONAL SAMPLE: Not for Sale
NDC 0245-0881-66

Divigel ®
(estradiol gel)
0.1%

0.5 mg
Rx only

7 packets
0.5 g gel provides 0.5 mg estradiol/packet

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 0.5 mg Packet Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 1 mg Packet Carton

PROFESSIONAL SAMPLE: Not for Sale
NDC 0245-0882-66

Divigel ®
(estradiol gel)
0.1%

1 mg
Rx only

7 packets
1 g gel provides 1 mg estradiol/packet

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 1 mg Packet Carton