{
"NDC": [
{
"NDCCode": "80267-020-63",
"PackageDescription": "1 BOTTLE in 1 CARTON (80267-020-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "80267-0020-63",
"ProductNDC": "80267-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Remedies Stool Softener",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20230707",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Live Betr LLC",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230707",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "80267-486-63",
"PackageDescription": "1 BOTTLE in 1 CARTON (80267-486-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "80267-0486-63",
"ProductNDC": "80267-486",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Stool Softener",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20211005",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Live Betr LLC",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211005",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "55289-020-63",
"PackageDescription": "63 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-63) ",
"NDC11Code": "55289-0020-63",
"ProductNDC": "55289-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130325",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are 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. , 2 Infections of the Genitourinary Tract:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), Staphylococcusspp., or E. coli. , 4 Infections of the Lower Respiratory Tract:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcusspp., or H. influenzae. .",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), 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, USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Tablets:Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension:Each 5 mL of reconstituted suspension contains 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable):Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules:Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide."
},
{
"NDCCode": "16590-020-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (16590-020-10)",
"NDC11Code": "16590-0020-10",
"ProductNDC": "16590-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065093",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "16590-020-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (16590-020-14)",
"NDC11Code": "16590-0020-14",
"ProductNDC": "16590-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065093",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "16590-020-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (16590-020-20)",
"NDC11Code": "16590-0020-20",
"ProductNDC": "16590-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065093",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "16590-020-21",
"PackageDescription": "21 TABLET, FILM COATED in 1 BOTTLE (16590-020-21)",
"NDC11Code": "16590-0020-21",
"ProductNDC": "16590-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065093",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "16590-020-28",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (16590-020-28)",
"NDC11Code": "16590-0020-28",
"ProductNDC": "16590-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065093",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "16590-020-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16590-020-30)",
"NDC11Code": "16590-0020-30",
"ProductNDC": "16590-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065093",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "51224-020-50",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (51224-020-50) ",
"NDC11Code": "51224-0020-50",
"ProductNDC": "51224-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205096",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol."
},
{
"NDCCode": "51224-020-60",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE (51224-020-60) ",
"NDC11Code": "51224-0020-60",
"ProductNDC": "51224-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190501",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205096",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190501",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol."
},
{
"NDCCode": "51224-020-70",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (51224-020-70) ",
"NDC11Code": "51224-0020-70",
"ProductNDC": "51224-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190501",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205096",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190501",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol."
},
{
"NDCCode": "61919-020-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (61919-020-14) ",
"NDC11Code": "61919-0020-14",
"ProductNDC": "61919-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091568",
"LabelerName": "DIRECT RX",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*. 1.1 Lower Respiratory Tract Infections. caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. 1.2 Acute Bacterial Otitis Media. caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. 1.3 Sinusitis. caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. 1.4 Skin and Skin Structure Infections. caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. 1.5 Urinary Tract Infections. caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. 1.6 Limitations of Use. When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets, USP should not be used.",
"Description": "Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin USP 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 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 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. Each film coated tablet for oral administration contains 250 mg, 500 mg or 875 mg amoxicillin USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each amoxicillin and clavulanate potassium tablet 250 mg/125 mg, 500 mg/125 mg or 875 mg/125 mg contains 0.63 mEq potassium. Inactive Ingredients. Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, surelease clear (aqueous ethyl cellulose dispersion), and titanium dioxide."
},
{
"NDCCode": "61919-020-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (61919-020-20) ",
"NDC11Code": "61919-0020-20",
"ProductNDC": "61919-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091568",
"LabelerName": "DIRECT RX",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*. 1.1 Lower Respiratory Tract Infections. caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. 1.2 Acute Bacterial Otitis Media. caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. 1.3 Sinusitis. caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. 1.4 Skin and Skin Structure Infections. caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. 1.5 Urinary Tract Infections. caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. 1.6 Limitations of Use. When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets, USP should not be used.",
"Description": "Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin USP 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 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 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. Each film coated tablet for oral administration contains 250 mg, 500 mg or 875 mg amoxicillin USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each amoxicillin and clavulanate potassium tablet 250 mg/125 mg, 500 mg/125 mg or 875 mg/125 mg contains 0.63 mEq potassium. Inactive Ingredients. Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, surelease clear (aqueous ethyl cellulose dispersion), and titanium dioxide."
},
{
"NDCCode": "71610-020-60",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-020-60) ",
"NDC11Code": "71610-0020-60",
"ProductNDC": "71610-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078596",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171214",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin HCl extended release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride (HCl) extended release tablets, USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin HCl, USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin HCl is 6.68. Metformin HCl extended release tablets, USP contain 500 mg or 750 mg of metformin HCl as the active ingredient. Metformin HCl extended release tablets 500 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose, magnesium stearate and microcrystalline cellulose. Metformin HCl extended release tablets, USP 750 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose and magnesium stearate.Dissolution Method: Test 10. System Components and Performance - Metformin HCl extended release tablets, USP comprises a dual hydrophilic polymer matrix system. Metformin HCl is combined with a drug release controlling polymer to form an \"inner\" phase, which is then incorporated as discrete particles into an \"external\" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
},
{
"NDCCode": "72256-020-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (72256-020-02) > 15 g in 1 CONTAINER (72256-020-01) ",
"NDC11Code": "72256-0020-02",
"ProductNDC": "72256-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Galaxyborn Satin Cushion No 23",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Octisalate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "DWAY CO LTD",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "1.63; 1.05; .45",
"StrengthUnit": "g/15g; g/15g; g/15g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"Description": "Uses:Helps prevent sunburn. Directions:1) Use at the sunscreen step after your basic skin care routine (it works as a sunblock, makeup base, and foundation) or Make-up before and after can be used.2) Using the puff applicator, press down on the cushion sponge to get the foundation on the puff.3) Close the inner lid tightly after each use to preserve freshness. Not closing the lid may cause the beneficial ingredients to evaporate and make the cushion sponge to shrink."
},
{
"NDCCode": "80267-000-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (80267-000-01) > 120 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "80267-0000-01",
"ProductNDC": "80267-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Allergy Relief Nasal",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20210127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207957",
"LabelerName": "Live Betr LLC",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210127",
"EndMarketingDatePackage": "20221101",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes."
},
{
"NDCCode": "80267-000-09",
"PackageDescription": "1 BOTTLE in 1 CARTON (80267-000-09) > 144 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "80267-0000-09",
"ProductNDC": "80267-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Allergy Relief Nasal",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20210127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207957",
"LabelerName": "Live Betr LLC",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210709",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes."
},
{
"NDCCode": "80267-001-71",
"PackageDescription": "1 BOTTLE in 1 CARTON (80267-001-71) > 50 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "80267-0001-71",
"ProductNDC": "80267-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Headache Pain Relief",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074661",
"LabelerName": "Live Betr LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210209",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. headache. minor pain of arthritis. muscular aches. backache. menstrual cramps. toothache. the common cold. temporarily reduces fever."
},
{
"NDCCode": "80267-002-74",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (80267-002-74) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "80267-0002-74",
"ProductNDC": "80267-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Chest Congestion Relief",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213420",
"LabelerName": "Live Betr LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2023-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210930",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "80267-010-74",
"PackageDescription": "14 BLISTER PACK in 1 CARTON (80267-010-74) / 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "80267-0010-74",
"ProductNDC": "80267-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Remedies Chest Congestion Relief",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213420",
"LabelerName": "Live Betr LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2023-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230320",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "80267-023-62",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (80267-023-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "80267-0023-62",
"ProductNDC": "80267-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Remedies Nighttime Cold And Flu Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221208",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Live Betr LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 6.25; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221208",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms:. nasal congestion. sinus congestion and pressure. cough due to minor throat and bronchial irritation. cough to help you sleep. minor aches and pains. headache. fever. sore throat. runny nose and sneezing. reduces swelling of nasal passages. temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage."
},
{
"NDCCode": "80267-100-62",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (80267-100-62) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "80267-0100-62",
"ProductNDC": "80267-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Remedies Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230724",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Live Betr LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230724",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. temporarily relieves these symptoms of the common cold:. runny nose. sneezing."
},
{
"NDCCode": "80267-100-78",
"PackageDescription": "1 BOTTLE in 1 CARTON (80267-100-78) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "80267-0100-78",
"ProductNDC": "80267-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Remedies Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230724",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Live Betr LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20231004",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. temporarily relieves these symptoms of the common cold:. runny nose. sneezing."
},
{
"NDCCode": "80267-194-71",
"PackageDescription": "1 BOTTLE in 1 CARTON (80267-194-71) > 50 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "80267-0194-71",
"ProductNDC": "80267-194",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Acid Reducer",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211012",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077351",
"LabelerName": "Live Betr LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211012",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "80267-350-62",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (80267-350-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "80267-0350-62",
"ProductNDC": "80267-350",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Cold And Flu Daytime Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211018",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Live Betr LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20211018",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms:. nasal congestion. sinus congestion and pressure. cough due to minor throat and bronchial irritation. minor aches and pains. headache. fever. sore throat. reduces swelling of nasal passages. temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "80267-401-95",
"PackageDescription": "1 BOTTLE in 1 CARTON (80267-401-95) > 45 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "80267-0401-95",
"ProductNDC": "80267-401",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Allergy Relief",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078336",
"LabelerName": "Live Betr LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210216",
"SamplePackage": "N"
},
{
"NDCCode": "80267-409-95",
"PackageDescription": "1 BOTTLE in 1 CARTON (80267-409-95) / 45 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "80267-0409-95",
"ProductNDC": "80267-409",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Remedies All Day Allergy Relief",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078336",
"LabelerName": "Live Betr LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230510",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "80267-428-65",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (80267-428-65) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "80267-0428-65",
"ProductNDC": "80267-428",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Gas Relief",
"NonProprietaryName": "Simethicone",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210930",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Live Betr LLC",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210930",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief of: 1 pressure, bloating and fullness, commonly referred to as gas."
},
{
"NDCCode": "80267-431-67",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (80267-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "80267-0431-67",
"ProductNDC": "80267-431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betr Sleep Aid",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210125",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "Live Betr LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210125",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>80267-020-63</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (80267-020-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>80267-0020-63</NDC11Code>
<ProductNDC>80267-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Remedies Stool Softener</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230707</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230707</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-486-63</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (80267-486-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>80267-0486-63</NDC11Code>
<ProductNDC>80267-486</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Stool Softener</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211005</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211005</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55289-020-63</NDCCode>
<PackageDescription>63 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-63) </PackageDescription>
<NDC11Code>55289-0020-63</NDC11Code>
<ProductNDC>55289-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061926</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are 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. , 2 Infections of the Genitourinary Tract:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), Staphylococcusspp., or E. coli. , 4 Infections of the Lower Respiratory Tract:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcusspp., or H. influenzae. .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), 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, USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Tablets:Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension:Each 5 mL of reconstituted suspension contains 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable):Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules:Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-020-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (16590-020-10)</PackageDescription>
<NDC11Code>16590-0020-10</NDC11Code>
<ProductNDC>16590-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065093</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>16590-020-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (16590-020-14)</PackageDescription>
<NDC11Code>16590-0020-14</NDC11Code>
<ProductNDC>16590-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065093</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>16590-020-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (16590-020-20)</PackageDescription>
<NDC11Code>16590-0020-20</NDC11Code>
<ProductNDC>16590-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065093</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>16590-020-21</NDCCode>
<PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (16590-020-21)</PackageDescription>
<NDC11Code>16590-0020-21</NDC11Code>
<ProductNDC>16590-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065093</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>16590-020-28</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (16590-020-28)</PackageDescription>
<NDC11Code>16590-0020-28</NDC11Code>
<ProductNDC>16590-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065093</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate.</Description>
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<IndicationAndUsage>Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP 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 C16H19N3O5S·3H2O 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. Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. In addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate.</Description>
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<NDC>
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<PackageDescription>100 TABLET, COATED in 1 BOTTLE (51224-020-50) </PackageDescription>
<NDC11Code>51224-0020-50</NDC11Code>
<ProductNDC>51224-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205096</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
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<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol.</Description>
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<NDCCode>51224-020-60</NDCCode>
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<EndMarketingDate>20251031</EndMarketingDate>
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<LabelerName>TAGI Pharma, Inc.</LabelerName>
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<LastUpdate>2025-11-04</LastUpdate>
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<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol.</Description>
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<NDC>
<NDCCode>51224-020-70</NDCCode>
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<EndMarketingDate>20251031</EndMarketingDate>
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<ApplicationNumber>ANDA205096</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
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<LastUpdate>2025-11-04</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol.</Description>
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<NDC>
<NDCCode>61919-020-14</NDCCode>
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<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*. 1.1 Lower Respiratory Tract Infections. caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. 1.2 Acute Bacterial Otitis Media. caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. 1.3 Sinusitis. caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. 1.4 Skin and Skin Structure Infections. caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. 1.5 Urinary Tract Infections. caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. 1.6 Limitations of Use. When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets, USP should not be used.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin USP 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 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 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. Each film coated tablet for oral administration contains 250 mg, 500 mg or 875 mg amoxicillin USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each amoxicillin and clavulanate potassium tablet 250 mg/125 mg, 500 mg/125 mg or 875 mg/125 mg contains 0.63 mEq potassium. Inactive Ingredients. Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, surelease clear (aqueous ethyl cellulose dispersion), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>61919-020-20</NDCCode>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*. 1.1 Lower Respiratory Tract Infections. caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. 1.2 Acute Bacterial Otitis Media. caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. 1.3 Sinusitis. caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. 1.4 Skin and Skin Structure Infections. caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. 1.5 Urinary Tract Infections. caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. 1.6 Limitations of Use. When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets, USP should not be used.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin USP 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 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 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. Each film coated tablet for oral administration contains 250 mg, 500 mg or 875 mg amoxicillin USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each amoxicillin and clavulanate potassium tablet 250 mg/125 mg, 500 mg/125 mg or 875 mg/125 mg contains 0.63 mEq potassium. Inactive Ingredients. Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, surelease clear (aqueous ethyl cellulose dispersion), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-020-60</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-020-60) </PackageDescription>
<NDC11Code>71610-0020-60</NDC11Code>
<ProductNDC>71610-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078596</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin HCl extended release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride (HCl) extended release tablets, USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin HCl, USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin HCl is 6.68. Metformin HCl extended release tablets, USP contain 500 mg or 750 mg of metformin HCl as the active ingredient. Metformin HCl extended release tablets 500 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose, magnesium stearate and microcrystalline cellulose. Metformin HCl extended release tablets, USP 750 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose and magnesium stearate.Dissolution Method: Test 10. System Components and Performance - Metformin HCl extended release tablets, USP comprises a dual hydrophilic polymer matrix system. Metformin HCl is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>72256-020-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (72256-020-02) > 15 g in 1 CONTAINER (72256-020-01) </PackageDescription>
<NDC11Code>72256-0020-02</NDC11Code>
<ProductNDC>72256-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Galaxyborn Satin Cushion No 23</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>DWAY CO LTD</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>1.63; 1.05; .45</StrengthNumber>
<StrengthUnit>g/15g; g/15g; g/15g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Uses:Helps prevent sunburn. Directions:1) Use at the sunscreen step after your basic skin care routine (it works as a sunblock, makeup base, and foundation) or Make-up before and after can be used.2) Using the puff applicator, press down on the cushion sponge to get the foundation on the puff.3) Close the inner lid tightly after each use to preserve freshness. Not closing the lid may cause the beneficial ingredients to evaporate and make the cushion sponge to shrink.</Description>
</NDC>
<NDC>
<NDCCode>80267-000-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (80267-000-01) > 120 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>80267-0000-01</NDC11Code>
<ProductNDC>80267-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Allergy Relief Nasal</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20210127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207957</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210127</StartMarketingDatePackage>
<EndMarketingDatePackage>20221101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-000-09</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (80267-000-09) > 144 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>80267-0000-09</NDC11Code>
<ProductNDC>80267-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Allergy Relief Nasal</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20210127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207957</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-001-71</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (80267-001-71) > 50 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>80267-0001-71</NDC11Code>
<ProductNDC>80267-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Headache Pain Relief</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074661</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. headache. minor pain of arthritis. muscular aches. backache. menstrual cramps. toothache. the common cold. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-002-74</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (80267-002-74) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>80267-0002-74</NDC11Code>
<ProductNDC>80267-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Chest Congestion Relief</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213420</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-010-74</NDCCode>
<PackageDescription>14 BLISTER PACK in 1 CARTON (80267-010-74) / 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>80267-0010-74</NDC11Code>
<ProductNDC>80267-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Remedies Chest Congestion Relief</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213420</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-023-62</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (80267-023-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>80267-0023-62</NDC11Code>
<ProductNDC>80267-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Remedies Nighttime Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221208</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 6.25; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221208</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms:. nasal congestion. sinus congestion and pressure. cough due to minor throat and bronchial irritation. cough to help you sleep. minor aches and pains. headache. fever. sore throat. runny nose and sneezing. reduces swelling of nasal passages. temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-100-62</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (80267-100-62) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>80267-0100-62</NDC11Code>
<ProductNDC>80267-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Remedies Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230724</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. temporarily relieves these symptoms of the common cold:. runny nose. sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-100-78</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (80267-100-78) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>80267-0100-78</NDC11Code>
<ProductNDC>80267-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Remedies Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230724</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. temporarily relieves these symptoms of the common cold:. runny nose. sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-194-71</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (80267-194-71) > 50 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>80267-0194-71</NDC11Code>
<ProductNDC>80267-194</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Acid Reducer</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211012</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077351</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-350-62</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (80267-350-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>80267-0350-62</NDC11Code>
<ProductNDC>80267-350</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Cold And Flu Daytime Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211018</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms:. nasal congestion. sinus congestion and pressure. cough due to minor throat and bronchial irritation. minor aches and pains. headache. fever. sore throat. reduces swelling of nasal passages. temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-401-95</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (80267-401-95) > 45 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>80267-0401-95</NDC11Code>
<ProductNDC>80267-401</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Allergy Relief</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078336</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>80267-409-95</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (80267-409-95) / 45 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>80267-0409-95</NDC11Code>
<ProductNDC>80267-409</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Remedies All Day Allergy Relief</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078336</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-428-65</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (80267-428-65) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>80267-0428-65</NDC11Code>
<ProductNDC>80267-428</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Gas Relief</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210930</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief of: 1 pressure, bloating and fullness, commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80267-431-67</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (80267-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>80267-0431-67</NDC11Code>
<ProductNDC>80267-431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betr Sleep Aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210125</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>Live Betr LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional sleeplessness.</IndicationAndUsage>
</NDC>
</NDCList>