NDC Code(s) : 0378-0053-01, 0378-0317-01, 0378-0372-01, 0378-0541-01
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cimetidinecimetidine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0053
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIMETIDINE(UNII: 80061L1WGD)
(CIMETIDINE - UNII:80061L1WGD) 		CIMETIDINE200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102(UNII: PNR0YF693Y)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
VANILLIN(UNII: CHI530446X)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color GREEN Score no score
Shape PENTAGON (5 sided) Size 8 mm
Flavor Imprint Code M;53
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0053-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product17/05/1994
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074246 05/17/1994
Cimetidinecimetidine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0317
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIMETIDINE(UNII: 80061L1WGD)
(CIMETIDINE - UNII:80061L1WGD) 		CIMETIDINE300 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102(UNII: PNR0YF693Y)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
VANILLIN(UNII: CHI530446X)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color GREEN Score no score
Shape PENTAGON (5 sided) Size 10 mm
Flavor Imprint Code M;317
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0317-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product17/05/1994
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074246 05/17/1994
Cimetidinecimetidine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0372
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIMETIDINE(UNII: 80061L1WGD)
(CIMETIDINE - UNII:80061L1WGD) 		CIMETIDINE400 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102(UNII: PNR0YF693Y)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
VANILLIN(UNII: CHI530446X)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color GREEN Score 2 pieces
Shape PENTAGON (5 sided) Size 11 mm
Flavor Imprint Code M;372
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0372-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product17/05/1994
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074246 05/17/1994
Cimetidinecimetidine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0541
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIMETIDINE(UNII: 80061L1WGD)
(CIMETIDINE - UNII:80061L1WGD) 		CIMETIDINE800 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102(UNII: PNR0YF693Y)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
VANILLIN(UNII: CHI530446X)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL Size 18 mm
Flavor Imprint Code M;541
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0541-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product17/05/1994
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074246 05/17/1994

LABELER - Mylan Pharmaceuticals Inc.(059295980)

PRINCIPAL DISPLAY PANEL

NDC 0378-0053-01

Cimetidine
Tablets, USP
200 mg

Rx only 100 Tablets

Each film-coated tablet contains:
Cimetidine, USP 200 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Protect from light.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMXA0053A1

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Cimetidine Tablets 200 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-0317-01

Cimetidine
Tablets, USP
300 mg

Rx only 100 Tablets

Each film-coated tablet contains:
Cimetidine, USP 300 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Protect from light.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMXA0317A1

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Cimetidine Tablets 300 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-0372-01

Cimetidine
Tablets, USP
400 mg

Rx only 100 Tablets

Each film-coated tablet contains:
Cimetidine, USP 400 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Protect from light.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMXA0372A1

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Cimetidine Tablets 400 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-0541-01

Cimetidine
Tablets, USP
800 mg

Rx only 100 Tablets

Each film-coated tablet contains:
Cimetidine, USP 800 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Protect from light.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMXA0541A2

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Cimetidine Tablets 800 mg Bottle Label