NDC Code 0591-3449-01 - Morphine Sulfate

NDC Code(s) : 0591-3449-01, 0591-3449-30, 0591-3450-01, 0591-3450-30, 0591-3451-01, 0591-3451-30, 0591-3452-01, 0591-3452-30, 0591-3576-01, 0591-3576-30, 0591-3453-01, 0591-3453-30
Packager : Watson Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0591-3449
Route of Administration	ORAL	DEA Schedule	CII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	20 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)

Product Characteristics
Color	YELLOW (Yellow Opaque Cap), WHITE (White Opaque Body)	Score	no score
Shape	CAPSULE	Size	14 mm
Flavor		Imprint Code	WATSON;3449;20;mg
Contains

#	Item Code	Package Description
Packaging
1	NDC:0591-3449-01	100 in 1 BOTTLE, PLASTIC
2	NDC:0591-3449-30	30 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200812	11/10/2011

Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0591-3450
Route of Administration	ORAL	DEA Schedule	CII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	30 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)

Product Characteristics
Color	BLUE (Blue Violet Opaque Cap), WHITE (White Opaque Body)	Score	no score
Shape	CAPSULE	Size	16 mm
Flavor		Imprint Code	WATSON;3450;30;mg
Contains

#	Item Code	Package Description
Packaging
1	NDC:0591-3450-01	100 in 1 BOTTLE, PLASTIC
2	NDC:0591-3450-30	30 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200812	11/10/2011

Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0591-3451
Route of Administration	ORAL	DEA Schedule	CII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	50 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)

Product Characteristics
Color	BLUE (Light Blue Opaque Cap), WHITE (White Opaque Body)	Score	no score
Shape	CAPSULE	Size	18 mm
Flavor		Imprint Code	WATSON;3451;50;mg
Contains

#	Item Code	Package Description
Packaging
1	NDC:0591-3451-01	100 in 1 BOTTLE, PLASTIC
2	NDC:0591-3451-30	30 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200812	11/10/2011

Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0591-3452
Route of Administration	ORAL	DEA Schedule	CII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	60 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)

Product Characteristics
Color	PINK (Pink Opaque Cap), WHITE (White Opaque Body)	Score	no score
Shape	CAPSULE	Size	19 mm
Flavor		Imprint Code	WATSON;3452;60;mg
Contains

#	Item Code	Package Description
Packaging
1	NDC:0591-3452-01	100 in 1 BOTTLE, PLASTIC
2	NDC:0591-3452-30	30 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200812	11/10/2011

Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0591-3576
Route of Administration	ORAL	DEA Schedule	CII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	80 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)

Product Characteristics
Color	BROWN (Flesh Opaque Cap), WHITE (White Opaque Body)	Score	no score
Shape	CAPSULE	Size	22 mm
Flavor		Imprint Code	WATSON;3576;80;mg
Contains

#	Item Code	Package Description
Packaging
1	NDC:0591-3576-01	100 in 1 BOTTLE, PLASTIC
2	NDC:0591-3576-30	30 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200812	11/10/2011

Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0591-3453
Route of Administration	ORAL	DEA Schedule	CII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	100 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)

Product Characteristics
Color	BLUE (Blue-Green Opaque Cap), WHITE (White Opaque Body)	Score	no score
Shape	CAPSULE	Size	22 mm
Flavor		Imprint Code	WATSON;3453;100;mg
Contains

#	Item Code	Package Description
Packaging
1	NDC:0591-3453-01	100 in 1 BOTTLE, PLASTIC
2	NDC:0591-3453-30	30 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200812	11/10/2011

NDC 0591-3449-01
API & Excipient Details

Morphine Sulfate marketed by Watson Laboratories, Inc. under NDC Code 0591-3449-01

NDC Code(s) : 0591-3449-01, 0591-3449-30, 0591-3450-01, 0591-3450-30, 0591-3451-01, 0591-3451-30, 0591-3452-01, 0591-3452-30, 0591-3576-01, 0591-3576-30, 0591-3453-01, 0591-3453-30
Packager : Watson Laboratories, Inc.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0591-3449-01 API & Excipient Details

Morphine Sulfate marketed by Watson Laboratories, Inc. under NDC Code 0591-3449-01

NDC Code(s) : 0591-3449-01, 0591-3449-30, 0591-3450-01, 0591-3450-30, 0591-3451-01, 0591-3451-30, 0591-3452-01, 0591-3452-30, 0591-3576-01, 0591-3576-30, 0591-3453-01, 0591-3453-30Packager : Watson Laboratories, Inc.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0591-3449-01
API & Excipient Details

NDC Code(s) : 0591-3449-01, 0591-3449-30, 0591-3450-01, 0591-3450-30, 0591-3451-01, 0591-3451-30, 0591-3452-01, 0591-3452-30, 0591-3576-01, 0591-3576-30, 0591-3453-01, 0591-3453-30
Packager : Watson Laboratories, Inc.