NDC Code(s) : 42254-043-60, 42254-043-72, 42254-053-14, 42254-053-60, 42254-053-90, 42254-053-72, 42254-053-07, 42254-053-30
Packager : Rebel Distributors Corp

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OmeprazoleOmeprazole CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-043(NDC:55111-157)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Omeprazole(UNII: KG60484QX9)
(omeprazole - UNII:KG60484QX9) 		Omeprazole10 mg
Inactive Ingredients
Ingredient Name Strength
crospovidone(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLOXAMER 124(UNII: 1S66E28KXA)
POVIDONE(UNII: FZ989GH94E)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ALCOHOL(UNII: 3K9958V90M)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color white (off-white to pale yellow) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code Omeprazole;10;mg;R;157
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42254-043-6060 in 1 BOTTLE
2NDC:42254-043-72120 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075576 10/22/2007
OmeprazoleOmeprazole CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-053(NDC:55111-158)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Omeprazole(UNII: KG60484QX9)
(omeprazole - UNII:KG60484QX9) 		Omeprazole20 mg
Inactive Ingredients
Ingredient Name Strength
crospovidone(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLOXAMER 124(UNII: 1S66E28KXA)
POVIDONE(UNII: FZ989GH94E)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ALCOHOL(UNII: 3K9958V90M)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color white (off-white to pale yellow) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code Omeprazole;20;mg;R;158
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42254-053-1414 in 1 BOTTLE
2NDC:42254-053-6060 in 1 BOTTLE
3NDC:42254-053-9090 in 1 BOTTLE
4NDC:42254-053-72120 in 1 BOTTLE
5NDC:42254-053-077 in 1 BOTTLE
6NDC:42254-053-3030 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075576 10/22/2007

LABELER - Rebel Distributors Corp(118802834)

Establishment
Name Address ID/FEI Business Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

PRINCIPAL DISPLAY PANEL

Omeprazole 10mg

PRINCIPAL DISPLAY PANEL

Omeprazole 20mg