{
"NDC": [
{
"NDCCode": "81964-003-51",
"PackageDescription": "75 mL in 1 BOTTLE (81964-003-51) ",
"NDC11Code": "81964-0003-51",
"ProductNDC": "81964-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
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"IndicationAndUsage": "AUGMENTIN ES-600 is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with. : 1 Recurrent or persistent acute otitis media due to S. pneumoniae(penicillin MICs less than or equal to 2 mcg/mL), H. influenzae(including beta-lactamase-producing strains), or M. catarrhalis(including beta-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)]. .",
"Description": "AUGMENTIN ES-600 is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum [see Warnings and Precautions (5.8)]. Each 5 mL of reconstituted AUGMENTIN ES-600 contains approximately 9 mg of potassium and 4 mg of sodium."
},
{
"NDCCode": "81964-003-54",
"PackageDescription": "200 mL in 1 BOTTLE (81964-003-54) ",
"NDC11Code": "81964-0003-54",
"ProductNDC": "81964-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220715",
"SamplePackage": "N",
"IndicationAndUsage": "AUGMENTIN ES-600 is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with. : 1 Recurrent or persistent acute otitis media due to S. pneumoniae(penicillin MICs less than or equal to 2 mcg/mL), H. influenzae(including beta-lactamase-producing strains), or M. catarrhalis(including beta-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)]. .",
"Description": "AUGMENTIN ES-600 is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum [see Warnings and Precautions (5.8)]. Each 5 mL of reconstituted AUGMENTIN ES-600 contains approximately 9 mg of potassium and 4 mg of sodium."
},
{
"NDCCode": "81964-003-69",
"PackageDescription": "125 mL in 1 BOTTLE (81964-003-69) ",
"NDC11Code": "81964-0003-69",
"ProductNDC": "81964-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220715",
"SamplePackage": "N",
"IndicationAndUsage": "AUGMENTIN ES-600 is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with. : 1 Recurrent or persistent acute otitis media due to S. pneumoniae(penicillin MICs less than or equal to 2 mcg/mL), H. influenzae(including beta-lactamase-producing strains), or M. catarrhalis(including beta-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)]. .",
"Description": "AUGMENTIN ES-600 is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum [see Warnings and Precautions (5.8)]. Each 5 mL of reconstituted AUGMENTIN ES-600 contains approximately 9 mg of potassium and 4 mg of sodium."
},
{
"NDCCode": "81964-203-51",
"PackageDescription": "75 mL in 1 BOTTLE (81964-203-51) ",
"NDC11Code": "81964-0203-51",
"ProductNDC": "81964-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220919",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050755",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220919",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with. : 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: .",
"Description": "Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum. [see Warnings and Precautions ( 5.8)] . Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension contains approximately 9 mg of potassium and 4 mg of sodium."
},
{
"NDCCode": "81964-207-51",
"PackageDescription": "75 mL in 1 BOTTLE (81964-207-51) ",
"NDC11Code": "81964-0207-51",
"ProductNDC": "81964-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050760",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infectionsofthe Ear, Nose, and Throat:Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcusspecies. (α-and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae. .",
"Description": "Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S·3H 2O, and the molecular weight is 419.45. Tablets:Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. Inactive ingredients in each 500 mg or 875 mg tablet: Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. For OralSuspension:Each 5 mL of reconstituted suspension contains 200 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium. Each 5 mL of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium. Inactive ingredients: flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Chewable Tablets:Each tablet contains 125 mg or 200 mg or 250 mg or 400 mg of amoxicillin as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: Mannitol, glycine, magnesium stearate, silica gel, flavorings, citric acid, saccharin sodium, and confectioner’s sugar. Inactive ingredients in each 200 mg and 400 mg chewable tablet: Mannitol, crospovidone, flavorings, magnesium stearate, and aspartame [see Warnings and Precautions ( 5.7) ]."
},
{
"NDCCode": "43598-003-51",
"PackageDescription": "75 mL in 1 BOTTLE (43598-003-51)",
"NDC11Code": "43598-0003-51",
"ProductNDC": "43598-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "Dr Reddys Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.",
"Description": "AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as."
},
{
"NDCCode": "58318-003-01",
"PackageDescription": "51 g in 1 CANISTER (58318-003-01) ",
"NDC11Code": "58318-0003-01",
"ProductNDC": "58318-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ultra Glow Fade",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180110",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part358A",
"LabelerName": "Keystone Laboratories",
"SubstanceName": "HYDROQUINONE",
"StrengthNumber": "1",
"StrengthUnit": "g/51g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180110",
"SamplePackage": "N",
"IndicationAndUsage": "Ultra Glow Fade Cream. 2% Hydroquinone ...... Skin Lightener."
},
{
"NDCCode": "66097-003-51",
"PackageDescription": "1 BOTTLE in 1 BOX (66097-003-51) / 51.5 g in 1 BOTTLE",
"NDC11Code": "66097-0003-51",
"ProductNDC": "66097-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunleya Age Minimizing Sun Care",
"ProprietaryNameSuffix": "Spf 50 Plus",
"NonProprietaryName": "Avobenzone, Homosalte, Octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130121",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "C.F.E.B. Sisley",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 150; 50; 100",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130121",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "74168-003-51",
"PackageDescription": "20000 mL in 1 BOTTLE (74168-003-51) ",
"NDC11Code": "74168-0003-51",
"ProductNDC": "74168-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Gel",
"ProprietaryNameSuffix": "75% Alcohol",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Yasili Cosmetics Co. Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200408",
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},
{
"NDCCode": "81964-203-54",
"PackageDescription": "200 mL in 1 BOTTLE (81964-203-54) ",
"NDC11Code": "81964-0203-54",
"ProductNDC": "81964-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220919",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050755",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220919",
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"IndicationAndUsage": "Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with. : 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: .",
"Description": "Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum. [see Warnings and Precautions ( 5.8)] . Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension contains approximately 9 mg of potassium and 4 mg of sodium."
},
{
"NDCCode": "81964-203-69",
"PackageDescription": "125 mL in 1 BOTTLE (81964-203-69) ",
"NDC11Code": "81964-0203-69",
"ProductNDC": "81964-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220919",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050755",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
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"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
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"LastUpdate": "2026-07-09",
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"IndicationAndUsage": "Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with. : 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: .",
"Description": "Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum. [see Warnings and Precautions ( 5.8)] . Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension contains approximately 9 mg of potassium and 4 mg of sodium."
},
{
"NDCCode": "81964-205-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (81964-205-01) ",
"NDC11Code": "81964-0205-01",
"ProductNDC": "81964-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062216",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220915",
"SamplePackage": "N",
"IndicationAndUsage": ". Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .",
"Description": "Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with \"AMOXIL ®\" over \"250\"; the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
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"PackageDescription": "500 CAPSULE in 1 BOTTLE (81964-205-05) ",
"NDC11Code": "81964-0205-05",
"ProductNDC": "81964-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062216",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220915",
"SamplePackage": "N",
"IndicationAndUsage": ". Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .",
"Description": "Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with \"AMOXIL ®\" over \"250\"; the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
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"PackageDescription": "100 CAPSULE in 1 BOTTLE (81964-205-10) ",
"NDC11Code": "81964-0205-10",
"ProductNDC": "81964-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
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"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062216",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": ". Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .",
"Description": "Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with \"AMOXIL ®\" over \"250\"; the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "81964-205-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (81964-205-60) ",
"NDC11Code": "81964-0205-60",
"ProductNDC": "81964-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
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"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062216",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": ". Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .",
"Description": "Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with \"AMOXIL ®\" over \"250\"; the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "81964-225-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (81964-225-01) ",
"NDC11Code": "81964-0225-01",
"ProductNDC": "81964-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062216",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"SamplePackage": "N",
"IndicationAndUsage": ". Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .",
"Description": "Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with \"AMOXIL ®\" over \"250\"; the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "81964-225-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (81964-225-05) ",
"NDC11Code": "81964-0225-05",
"ProductNDC": "81964-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062216",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220915",
"SamplePackage": "N",
"IndicationAndUsage": ". Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .",
"Description": "Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with \"AMOXIL ®\" over \"250\"; the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "81964-350-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (81964-350-10) ",
"NDC11Code": "81964-0350-10",
"ProductNDC": "81964-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
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"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062216",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": ". Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .",
"Description": "Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with \"AMOXIL ®\" over \"250\"; the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "81964-350-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (81964-350-60) ",
"NDC11Code": "81964-0350-60",
"ProductNDC": "81964-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062216",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": ". Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .",
"Description": "Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with \"AMOXIL ®\" over \"250\"; the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "81964-350-98",
"PackageDescription": "8 CAPSULE in 1 PAIL (81964-350-98) ",
"NDC11Code": "81964-0350-98",
"ProductNDC": "81964-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062216",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": ". Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .",
"Description": "Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with \"AMOXIL ®\" over \"250\"; the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with \"AMOXIL ®\" over \"500\". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "42515-003-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (42515-003-01) / .5 mL in 1 SYRINGE (42515-003-00) ",
"NDC11Code": "42515-0003-01",
"ProductNDC": "42515-003",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Ixchiq",
"NonProprietaryName": "Chikungunya Vaccine, Live-attenuated",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125777",
"LabelerName": "Valneva Scotland Ltd.",
"SubstanceName": "CHIKUNGUNYA VIRUS LR2006 OPY1 (ATTENUATED STRAIN) ANTIGEN",
"StrengthNumber": "3",
"StrengthUnit": "[TCID_50]/.5mL",
"Status": "Deprecated",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240115",
"SamplePackage": "N",
"IndicationAndUsage": "IXCHIQ is a vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody levels [See Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies.",
"Description": "IXCHIQ (Chikungunya Vaccine, Live) is a solution for intramuscular injection. IXCHIQ is supplied as a vial of sterile, Lyophilized Antigen Component, Live, and a syringe of Sterile Water Diluent Component. The Lyophilized Antigen Component, Live, is reconstituted at the time of use with the accompanying Sterile Water Diluent Component to form IXCHIQ. The Lyophilized Antigen Component, Live, is a white to slightly yellowish powder. After reconstitution, IXCHIQ is a clear colorless to slightly yellowish solution. IXCHIQ contains live, attenuated chikungunya virus (generated by reverse genetics from La Réunion strain LR-CHIKV clone LR2006 OPY1). The attenuated virus has a deletion in non-structural protein 3, which encodes a component of the viral replicase complex, and replicates less efficiently than the wild-type CHIKV. The vaccine virus is propagated in Vero cells (a continuous line of monkey kidney cells) in media containing amino acids, vitamins, minerals and fetal bovine serum. The viral harvests are pooled, clarified and concentrated. The virus is purified by chromatography and ultracentrifugation, mixed with formulation buffer and lyophilized. After reconstitution, each approximately 0.5-mL dose contains not less than 3.0 log10 TCID50 (Tissue Culture Infectious Dose 50%) of live, attenuated chikungunya virus. Each dose also contains 0.05 mg recombinant human albumin, 25 mg sucrose, 2.5 mg D-sorbitol, 0.75 mg L-methionine, 0.51 mg magnesium chloride hexahydrate, 3.68 mg trisodium citrate di-hydrate, 0.313 mg di-potassium hydrogen phosphate, and 0.098 mg potassium di-hydrogen phosphate. Each dose may contain residual amounts of Vero cell proteins (less than 5 ng/dose), Vero cell DNA (less than 10 pg/dose), bovine serum albumin (less than 500 pg/dose) and protamine sulphate (less than 1 mcg/dose), from the manufacturing process. IXCHIQ does not contain a preservative. The stoppers of the syringes containing Sterile Water Diluent Component and the stoppers of the vials containing Lyophilized Antigen Component, Live, are not made with natural rubber latex."
},
{
"NDCCode": "52937-003-16",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (52937-003-16) / 16 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "52937-0003-16",
"ProductNDC": "52937-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vascepa",
"NonProprietaryName": "Icosapent Ethyl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160916",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202057",
"LabelerName": "Amarin Pharma Inc.",
"SubstanceName": "ICOSAPENT ETHYL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160916",
"SamplePackage": "N",
"IndicationAndUsage": "VASCEPA® (icosapent ethyl) is indicated: 1 as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease ordiabetes mellitus and 2 or more additional risk factors for cardiovascular disease., 2 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.",
"Description": "VASCEPA, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Each VASCEPA capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. VASCEPA capsules also contain the following inactive ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water."
},
{
"NDCCode": "52937-003-40",
"PackageDescription": "240 CAPSULE in 1 BOTTLE (52937-003-40) ",
"NDC11Code": "52937-0003-40",
"ProductNDC": "52937-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vascepa",
"NonProprietaryName": "Icosapent Ethyl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160916",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202057",
"LabelerName": "Amarin Pharma Inc.",
"SubstanceName": "ICOSAPENT ETHYL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160916",
"SamplePackage": "N",
"IndicationAndUsage": "VASCEPA® (icosapent ethyl) is indicated: 1 as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease ordiabetes mellitus and 2 or more additional risk factors for cardiovascular disease., 2 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.",
"Description": "VASCEPA, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Each VASCEPA capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. VASCEPA capsules also contain the following inactive ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water."
},
{
"NDCCode": "55490-003-01",
"PackageDescription": "5 CLOTH in 1 PACKET (55490-003-01) ",
"NDC11Code": "55490-0003-01",
"ProductNDC": "55490-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "75% Alcohol Wipes",
"NonProprietaryName": "Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Baijieyuan Biotechnology (Shandong) Co., Ltd.",
"SubstanceName": "BRONOPOL; BENZALKONIUM CHLORIDE; ALCOHOL; BENZETHONIUM CHLORIDE; PHENOXYETHANOL",
"StrengthNumber": ".0969; .0969; 242.25; .0646; .1938",
"StrengthUnit": "g/51; g/51; g/51; g/51; g/51",
"Status": "Deprecated",
"LastUpdate": "2020-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200610",
"SamplePackage": "N"
},
{
"NDCCode": "61658-003-01",
"PackageDescription": "6 POUCH in 1 BOX (61658-003-01) / 1 PATCH in 1 POUCH",
"NDC11Code": "61658-0003-01",
"ProductNDC": "61658-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ynby Pain Relieving",
"NonProprietaryName": "Camphor, Menthol, And Methyl Salicylate",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230925",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "YUNNAN BAIYAO GROUP CO., LTD.",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "40.74; 51.84; 117.998",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230925",
"SamplePackage": "N",
"IndicationAndUsage": "UsesFor the temporary relief of minor aches and pains of muscles and joints due to:simple backachearthritisstrainsbruisessprains."
},
{
"NDCCode": "61658-003-02",
"PackageDescription": "12 POUCH in 1 BOX (61658-003-02) / 1 PATCH in 1 POUCH",
"NDC11Code": "61658-0003-02",
"ProductNDC": "61658-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ynby Pain Relieving",
"NonProprietaryName": "Camphor, Menthol, And Methyl Salicylate",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230925",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "YUNNAN BAIYAO GROUP CO., LTD.",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "40.74; 51.84; 117.998",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230925",
"SamplePackage": "N",
"IndicationAndUsage": "UsesFor the temporary relief of minor aches and pains of muscles and joints due to:simple backachearthritisstrainsbruisessprains."
},
{
"NDCCode": "81964-204-07",
"PackageDescription": "75 mL in 1 BOTTLE (81964-204-07) ",
"NDC11Code": "81964-0204-07",
"ProductNDC": "81964-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20221205",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050575",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "250; 62.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221205",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections- caused by beta‑lactamase–producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. , 3 Sinusitis- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. , 4 Skin and Skin Structure Infections- caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiellaspecies. , 5 Urinary Tract Infections- caused by beta‑lactamase–producing isolates of E. coli, Klebsiellaspecies, and Enterobacterspecies. .",
"Description": ". Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Amoxicillin and Clavulanate Potassium Tablets: 1 250 mg/125 mg:Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). ."
},
{
"NDCCode": "81964-204-10",
"PackageDescription": "100 mL in 1 BOTTLE (81964-204-10) ",
"NDC11Code": "81964-0204-10",
"ProductNDC": "81964-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20221205",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050575",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "250; 62.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221205",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections- caused by beta‑lactamase–producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. , 3 Sinusitis- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. , 4 Skin and Skin Structure Infections- caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiellaspecies. , 5 Urinary Tract Infections- caused by beta‑lactamase–producing isolates of E. coli, Klebsiellaspecies, and Enterobacterspecies. .",
"Description": ". Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Amoxicillin and Clavulanate Potassium Tablets: 1 250 mg/125 mg:Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). ."
},
{
"NDCCode": "81964-204-15",
"PackageDescription": "150 mL in 1 BOTTLE (81964-204-15) ",
"NDC11Code": "81964-0204-15",
"ProductNDC": "81964-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Description": ". Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Amoxicillin and Clavulanate Potassium Tablets: 1 250 mg/125 mg:Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). ."
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"Description": "Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S·3H 2O, and the molecular weight is 419.45. Tablets:Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. Inactive ingredients in each 500 mg or 875 mg tablet: Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. For OralSuspension:Each 5 mL of reconstituted suspension contains 200 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium. Each 5 mL of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium. Inactive ingredients: flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Chewable Tablets:Each tablet contains 125 mg or 200 mg or 250 mg or 400 mg of amoxicillin as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: Mannitol, glycine, magnesium stearate, silica gel, flavorings, citric acid, saccharin sodium, and confectioner’s sugar. Inactive ingredients in each 200 mg and 400 mg chewable tablet: Mannitol, crospovidone, flavorings, magnesium stearate, and aspartame [see Warnings and Precautions ( 5.7) ]."
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<Description>Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum. [see Warnings and Precautions ( 5.8)] . Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension contains approximately 9 mg of potassium and 4 mg of sodium.</Description>
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<Description>Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S·3H 2O, and the molecular weight is 419.45. Tablets:Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. Inactive ingredients in each 500 mg or 875 mg tablet: Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. For OralSuspension:Each 5 mL of reconstituted suspension contains 200 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium. Each 5 mL of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium. Inactive ingredients: flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Chewable Tablets:Each tablet contains 125 mg or 200 mg or 250 mg or 400 mg of amoxicillin as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: Mannitol, glycine, magnesium stearate, silica gel, flavorings, citric acid, saccharin sodium, and confectioner’s sugar. Inactive ingredients in each 200 mg and 400 mg chewable tablet: Mannitol, crospovidone, flavorings, magnesium stearate, and aspartame [see Warnings and Precautions ( 5.7) ].</Description>
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<IndicationAndUsage>AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.</IndicationAndUsage>
<Description>AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as.</Description>
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<PackageDescription>51 g in 1 CANISTER (58318-003-01) </PackageDescription>
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<ProductNDC>58318-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ultra Glow Fade</ProprietaryName>
<NonProprietaryName>Hydroquinone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part358A</ApplicationNumber>
<LabelerName>Keystone Laboratories</LabelerName>
<SubstanceName>HYDROQUINONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/51g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ultra Glow Fade Cream. 2% Hydroquinone ...... Skin Lightener.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66097-003-51</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (66097-003-51) / 51.5 g in 1 BOTTLE</PackageDescription>
<NDC11Code>66097-0003-51</NDC11Code>
<ProductNDC>66097-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunleya Age Minimizing Sun Care</ProprietaryName>
<ProprietaryNameSuffix>Spf 50 Plus</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalte, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130121</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>C.F.E.B. Sisley</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 150; 50; 100</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74168-003-51</NDCCode>
<PackageDescription>20000 mL in 1 BOTTLE (74168-003-51) </PackageDescription>
<NDC11Code>74168-0003-51</NDC11Code>
<ProductNDC>74168-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Gel</ProprietaryName>
<ProprietaryNameSuffix>75% Alcohol</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Yasili Cosmetics Co. Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>81964-203-54</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (81964-203-54) </PackageDescription>
<NDC11Code>81964-0203-54</NDC11Code>
<ProductNDC>81964-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220919</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050755</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with. : 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: .</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum. [see Warnings and Precautions ( 5.8)] . Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension contains approximately 9 mg of potassium and 4 mg of sodium.</Description>
</NDC>
<NDC>
<NDCCode>81964-203-69</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (81964-203-69) </PackageDescription>
<NDC11Code>81964-0203-69</NDC11Code>
<ProductNDC>81964-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220919</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050755</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with. : 1 Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: .</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum. [see Warnings and Precautions ( 5.8)] . Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium (600 mg/42.9 mg) for Oral Suspension contains approximately 9 mg of potassium and 4 mg of sodium.</Description>
</NDC>
<NDC>
<NDCCode>81964-205-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (81964-205-01) </PackageDescription>
<NDC11Code>81964-0205-01</NDC11Code>
<ProductNDC>81964-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062216</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with "AMOXIL ®" over "250"; the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
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<ProductNDC>81964-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062216</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with "AMOXIL ®" over "250"; the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
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<ProductNDC>81964-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062216</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with "AMOXIL ®" over "250"; the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062216</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with "AMOXIL ®" over "250"; the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>81964-225-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (81964-225-01) </PackageDescription>
<NDC11Code>81964-0225-01</NDC11Code>
<ProductNDC>81964-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062216</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with "AMOXIL ®" over "250"; the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>81964-225-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (81964-225-05) </PackageDescription>
<NDC11Code>81964-0225-05</NDC11Code>
<ProductNDC>81964-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062216</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with "AMOXIL ®" over "250"; the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>81964-350-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (81964-350-10) </PackageDescription>
<NDC11Code>81964-0350-10</NDC11Code>
<ProductNDC>81964-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062216</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with "AMOXIL ®" over "250"; the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>81964-350-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (81964-350-60) </PackageDescription>
<NDC11Code>81964-0350-60</NDC11Code>
<ProductNDC>81964-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062216</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with "AMOXIL ®" over "250"; the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>81964-350-98</NDCCode>
<PackageDescription>8 CAPSULE in 1 PAIL (81964-350-98) </PackageDescription>
<NDC11Code>81964-0350-98</NDC11Code>
<ProductNDC>81964-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062216</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4) , 2 In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram‑positive and Gram‑negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin capsules, USP: blue and pink capsule. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250 mg capsule are imprinted with "AMOXIL ®" over "250"; the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. Amoxicillin capsules, USP: white capsule. Each capsule of amoxicillin, with white opaque cap and body, contains 500 mg amoxicillin as the trihydrate. The cap and body of the cap and body of the 500 mg capsule are imprinted with "AMOXIL ®" over "500". Inactive ingredients: gelatin, magnesium stearate, and titanium dioxide. Amoxicillinfor oral suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>42515-003-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (42515-003-01) / .5 mL in 1 SYRINGE (42515-003-00) </PackageDescription>
<NDC11Code>42515-0003-01</NDC11Code>
<ProductNDC>42515-003</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Ixchiq</ProprietaryName>
<NonProprietaryName>Chikungunya Vaccine, Live-attenuated</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125777</ApplicationNumber>
<LabelerName>Valneva Scotland Ltd.</LabelerName>
<SubstanceName>CHIKUNGUNYA VIRUS LR2006 OPY1 (ATTENUATED STRAIN) ANTIGEN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[TCID_50]/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IXCHIQ is a vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody levels [See Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies.</IndicationAndUsage>
<Description>IXCHIQ (Chikungunya Vaccine, Live) is a solution for intramuscular injection. IXCHIQ is supplied as a vial of sterile, Lyophilized Antigen Component, Live, and a syringe of Sterile Water Diluent Component. The Lyophilized Antigen Component, Live, is reconstituted at the time of use with the accompanying Sterile Water Diluent Component to form IXCHIQ. The Lyophilized Antigen Component, Live, is a white to slightly yellowish powder. After reconstitution, IXCHIQ is a clear colorless to slightly yellowish solution. IXCHIQ contains live, attenuated chikungunya virus (generated by reverse genetics from La Réunion strain LR-CHIKV clone LR2006 OPY1). The attenuated virus has a deletion in non-structural protein 3, which encodes a component of the viral replicase complex, and replicates less efficiently than the wild-type CHIKV. The vaccine virus is propagated in Vero cells (a continuous line of monkey kidney cells) in media containing amino acids, vitamins, minerals and fetal bovine serum. The viral harvests are pooled, clarified and concentrated. The virus is purified by chromatography and ultracentrifugation, mixed with formulation buffer and lyophilized. After reconstitution, each approximately 0.5-mL dose contains not less than 3.0 log10 TCID50 (Tissue Culture Infectious Dose 50%) of live, attenuated chikungunya virus. Each dose also contains 0.05 mg recombinant human albumin, 25 mg sucrose, 2.5 mg D-sorbitol, 0.75 mg L-methionine, 0.51 mg magnesium chloride hexahydrate, 3.68 mg trisodium citrate di-hydrate, 0.313 mg di-potassium hydrogen phosphate, and 0.098 mg potassium di-hydrogen phosphate. Each dose may contain residual amounts of Vero cell proteins (less than 5 ng/dose), Vero cell DNA (less than 10 pg/dose), bovine serum albumin (less than 500 pg/dose) and protamine sulphate (less than 1 mcg/dose), from the manufacturing process. IXCHIQ does not contain a preservative. The stoppers of the syringes containing Sterile Water Diluent Component and the stoppers of the vials containing Lyophilized Antigen Component, Live, are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>52937-003-16</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (52937-003-16) / 16 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>52937-0003-16</NDC11Code>
<ProductNDC>52937-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vascepa</ProprietaryName>
<NonProprietaryName>Icosapent Ethyl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160916</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202057</ApplicationNumber>
<LabelerName>Amarin Pharma Inc.</LabelerName>
<SubstanceName>ICOSAPENT ETHYL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VASCEPA® (icosapent ethyl) is indicated: 1 as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease ordiabetes mellitus and 2 or more additional risk factors for cardiovascular disease., 2 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.</IndicationAndUsage>
<Description>VASCEPA, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Each VASCEPA capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. VASCEPA capsules also contain the following inactive ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>52937-003-40</NDCCode>
<PackageDescription>240 CAPSULE in 1 BOTTLE (52937-003-40) </PackageDescription>
<NDC11Code>52937-0003-40</NDC11Code>
<ProductNDC>52937-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vascepa</ProprietaryName>
<NonProprietaryName>Icosapent Ethyl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160916</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202057</ApplicationNumber>
<LabelerName>Amarin Pharma Inc.</LabelerName>
<SubstanceName>ICOSAPENT ETHYL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VASCEPA® (icosapent ethyl) is indicated: 1 as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease ordiabetes mellitus and 2 or more additional risk factors for cardiovascular disease., 2 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.</IndicationAndUsage>
<Description>VASCEPA, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Each VASCEPA capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. VASCEPA capsules also contain the following inactive ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>55490-003-01</NDCCode>
<PackageDescription>5 CLOTH in 1 PACKET (55490-003-01) </PackageDescription>
<NDC11Code>55490-0003-01</NDC11Code>
<ProductNDC>55490-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>75% Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Baijieyuan Biotechnology (Shandong) Co., Ltd.</LabelerName>
<SubstanceName>BRONOPOL; BENZALKONIUM CHLORIDE; ALCOHOL; BENZETHONIUM CHLORIDE; PHENOXYETHANOL</SubstanceName>
<StrengthNumber>.0969; .0969; 242.25; .0646; .1938</StrengthNumber>
<StrengthUnit>g/51; g/51; g/51; g/51; g/51</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61658-003-01</NDCCode>
<PackageDescription>6 POUCH in 1 BOX (61658-003-01) / 1 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>61658-0003-01</NDC11Code>
<ProductNDC>61658-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ynby Pain Relieving</ProprietaryName>
<NonProprietaryName>Camphor, Menthol, And Methyl Salicylate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230925</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>YUNNAN BAIYAO GROUP CO., LTD.</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>40.74; 51.84; 117.998</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesFor the temporary relief of minor aches and pains of muscles and joints due to:simple backachearthritisstrainsbruisessprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61658-003-02</NDCCode>
<PackageDescription>12 POUCH in 1 BOX (61658-003-02) / 1 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>61658-0003-02</NDC11Code>
<ProductNDC>61658-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ynby Pain Relieving</ProprietaryName>
<NonProprietaryName>Camphor, Menthol, And Methyl Salicylate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230925</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>YUNNAN BAIYAO GROUP CO., LTD.</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>40.74; 51.84; 117.998</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesFor the temporary relief of minor aches and pains of muscles and joints due to:simple backachearthritisstrainsbruisessprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81964-204-07</NDCCode>
<PackageDescription>75 mL in 1 BOTTLE (81964-204-07) </PackageDescription>
<NDC11Code>81964-0204-07</NDC11Code>
<ProductNDC>81964-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221205</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050575</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 62.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections- caused by beta‑lactamase–producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. , 3 Sinusitis- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. , 4 Skin and Skin Structure Infections- caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiellaspecies. , 5 Urinary Tract Infections- caused by beta‑lactamase–producing isolates of E. coli, Klebsiellaspecies, and Enterobacterspecies. .</IndicationAndUsage>
<Description>. Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Amoxicillin and Clavulanate Potassium Tablets: 1 250 mg/125 mg:Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). .</Description>
</NDC>
<NDC>
<NDCCode>81964-204-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (81964-204-10) </PackageDescription>
<NDC11Code>81964-0204-10</NDC11Code>
<ProductNDC>81964-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221205</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050575</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 62.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections- caused by beta‑lactamase–producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. , 3 Sinusitis- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. , 4 Skin and Skin Structure Infections- caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiellaspecies. , 5 Urinary Tract Infections- caused by beta‑lactamase–producing isolates of E. coli, Klebsiellaspecies, and Enterobacterspecies. .</IndicationAndUsage>
<Description>. Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Amoxicillin and Clavulanate Potassium Tablets: 1 250 mg/125 mg:Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). .</Description>
</NDC>
<NDC>
<NDCCode>81964-204-15</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE (81964-204-15) </PackageDescription>
<NDC11Code>81964-0204-15</NDC11Code>
<ProductNDC>81964-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221205</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050575</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 62.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections- caused by beta‑lactamase–producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. , 3 Sinusitis- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. , 4 Skin and Skin Structure Infections- caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiellaspecies. , 5 Urinary Tract Infections- caused by beta‑lactamase–producing isolates of E. coli, Klebsiellaspecies, and Enterobacterspecies. .</IndicationAndUsage>
<Description>. Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Amoxicillin and Clavulanate Potassium Tablets: 1 250 mg/125 mg:Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). .</Description>
</NDC>
<NDC>
<NDCCode>81964-207-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (81964-207-50) </PackageDescription>
<NDC11Code>81964-0207-50</NDC11Code>
<ProductNDC>81964-207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050760</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infectionsofthe Ear, Nose, and Throat:Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcusspecies. (α-and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae. .</IndicationAndUsage>
<Description>Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S·3H 2O, and the molecular weight is 419.45. Tablets:Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. Inactive ingredients in each 500 mg or 875 mg tablet: Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. For OralSuspension:Each 5 mL of reconstituted suspension contains 200 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium. Each 5 mL of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium. Inactive ingredients: flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Chewable Tablets:Each tablet contains 125 mg or 200 mg or 250 mg or 400 mg of amoxicillin as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: Mannitol, glycine, magnesium stearate, silica gel, flavorings, citric acid, saccharin sodium, and confectioner’s sugar. Inactive ingredients in each 200 mg and 400 mg chewable tablet: Mannitol, crospovidone, flavorings, magnesium stearate, and aspartame [see Warnings and Precautions ( 5.7) ].</Description>
</NDC>
</NDCList>