NDC Code(s) : 0430-0836-95, 0430-0836-20, 0430-0838-95, 0430-0838-19
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DORYXdoxycycline hyclate CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-0836
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE(UNII: 19XTS3T51U)
(DOXYCYCLINE ANHYDROUS - UNII:334895S862) 		DOXYCYCLINE ANHYDROUS75 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN(UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, WHEAT(UNII: 79QS2MG2LP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color ORANGE, GREEN Score no score
Shape CAPSULE (Capsule) Size 14 mm
Flavor Imprint Code DORYX;75mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0430-0836-9524 in 1 KIT 01/09/1985
11 in 1 CARTON
17 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:0430-0836-2048 in 1 KIT 01/09/1985
260 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050582 09/01/1985 09/30/2006
DORYXdoxycycline hyclate CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-0838
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE(UNII: 19XTS3T51U)
(DOXYCYCLINE ANHYDROUS - UNII:334895S862) 		DOXYCYCLINE ANHYDROUS100 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN(UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, WHEAT(UNII: 79QS2MG2LP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW, BLUE Score no score
Shape CAPSULE (Capsule) Size 16 mm
Flavor Imprint Code DORYX;WC
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0430-0838-9524 in 1 KIT 01/09/1985
11 in 1 CARTON
17 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:0430-0838-1948 in 1 KIT 01/09/1985
250 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050582 09/01/1985 08/30/2007

PRINCIPAL DISPLAY PANEL

NDC 0430-0836-96
DORYX
(Coated Doxycycline 
Hyclate Pellets)
75 mg
7 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL NDC 0430-0836-96 DORYX (Coated Doxycycline Hyclate Pellets) 75 mg 7 Capsules Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0430-0836-20
DORYX
(Coated Doxycycline 
Hyclate Pellets)
75 mg
60 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL NDC 0430-0836-20 DORYX (Coated Doxycycline Hyclate Pellets) 75 mg 60 Capsules Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0430-0838-96
DORYX
(Coated Doxycycline 
Hyclate Pellets)
100 mg
7 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL NDC 0430-0838-96 DORYX (Coated Doxycycline Hyclate Pellets) 100 mg 7 Capsules Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0430-0838-19
DORYX
(Coated Doxycycline 
Hyclate Pellets)
100 mg
50 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL NDC 0430-0838-19 DORYX (Coated Doxycycline Hyclate Pellets) 100 mg 50 Capsules Rx Only