NDC Code 43858-354-01 - Amoxicillin Trihydrate

NDC Code(s) : 43858-352-31, 43858-352-76, 43858-352-01, 43858-352-05, 43858-355-31, 43858-355-76, 43858-355-01, 43858-355-05, 43858-353-20, 43858-353-01, 43858-354-20, 43858-354-01, 43858-151-58, 43858-151-46, 43858-151-55, 43858-149-52, 43858-149-57, 43858-149-46, 43858-152-58, 43858-152-46, 43858-152-55, 43858-150-52, 43858-150-57, 43858-150-46
Packager : Sandoz GmbH

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AmoxicillinAmoxicillin CAPSULE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43858-352
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	250 mg

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN(UNII: 2G86QN327L)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SHELLAC(UNII: 46N107B71O)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)

Product Characteristics
Color	YELLOW (Opaque)	Score	no score
Shape	CAPSULE	Size	18 mm
Flavor		Imprint Code	AMOX;250;GG;848
Contains

#	Item Code	Package Description
Packaging
1	NDC:43858-352-76	12 in 1 PACKAGE
1	NDC:43858-352-31	30 in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:43858-352-01	100 in 1 BOTTLE Type 0: Not a Combination Product
3	NDC:43858-352-05	500 in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA064076	09/30/1994

AmoxicillinAmoxicillin CAPSULE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43858-355
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	500 mg

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN(UNII: 2G86QN327L)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SHELLAC(UNII: 46N107B71O)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)

Product Characteristics
Color	YELLOW (Opaque)	Score	no score
Shape	CAPSULE	Size	22 mm
Flavor		Imprint Code	AMOX;500;GG;849
Contains

#	Item Code	Package Description
Packaging
1	NDC:43858-355-76	12 in 1 PACKAGE
1	NDC:43858-355-31	30 in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:43858-355-01	100 in 1 BOTTLE Type 0: Not a Combination Product
3	NDC:43858-355-05	500 in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA064076	09/30/1994

AmoxicillinAmoxicillin TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43858-353
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	500 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (slightly yellowish)	Score	no score
Shape	OVAL	Size	18 mm
Flavor		Imprint Code	GG;961;500
Contains

#	Item Code	Package Description
Packaging
1	NDC:43858-353-20	20 in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:43858-353-01	100 in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065228	07/13/2005

AmoxicillinAmoxicillin TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43858-354
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	875 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (slightly yellowish)	Score	2 pieces
Shape	OVAL	Size	21 mm
Flavor		Imprint Code	GG;962;875
Contains

#	Item Code	Package Description
Packaging
1	NDC:43858-354-20	20 in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:43858-354-01	100 in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065228	07/13/2005

AmoxicillinAmoxicillin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43858-151
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	125 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)

#	Item Code	Package Description
Packaging
1	NDC:43858-151-58	80 mL in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:43858-151-46	100 mL in 1 BOTTLE Type 0: Not a Combination Product
3	NDC:43858-151-55	150 mL in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065387	03/26/2007

AmoxicillinAmoxicillin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43858-149
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	200 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)

#	Item Code	Package Description
Packaging
1	NDC:43858-149-52	50 mL in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:43858-149-57	75 mL in 1 BOTTLE Type 0: Not a Combination Product
3	NDC:43858-149-46	100 mL in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065378	03/26/2007

AmoxicillinAmoxicillin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43858-152
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	250 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)

#	Item Code	Package Description
Packaging
1	NDC:43858-152-58	80 mL in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:43858-152-46	100 mL in 1 BOTTLE Type 0: Not a Combination Product
3	NDC:43858-152-55	150 mL in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065387	03/26/2007

AmoxicillinAmoxicillin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43858-150
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	400 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)

#	Item Code	Package Description
Packaging
1	NDC:43858-150-52	50 mL in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:43858-150-57	75 mL in 1 BOTTLE Type 0: Not a Combination Product
3	NDC:43858-150-46	100 mL in 1 BOTTLE Type 0: Not a Combination Product