{
"NDC": [
{
"NDCCode": "61957-3109-7",
"PackageDescription": ".7 mL in 1 PACKET (61957-3109-7) ",
"NDC11Code": "61957-3109-07",
"ProductNDC": "61957-3109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Forever Skin Glow 24h Wear Radiant Foundation Perfection And Hydration Concentrated Floral Skincare With Suncreen Broad Spectrum Spf 15 6.5n",
"NonProprietaryName": "Octisalate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "45; 9.4",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions."
},
{
"NDCCode": "61957-3109-0",
"PackageDescription": "30 mL in 1 BOTTLE (61957-3109-0) ",
"NDC11Code": "61957-3109-00",
"ProductNDC": "61957-3109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Forever Skin Glow 24h Wear Radiant Foundation Perfection And Hydration Concentrated Floral Skincare With Suncreen Broad Spectrum Spf 15 6.5n",
"NonProprietaryName": "Octisalate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "45; 9.4",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions."
},
{
"NDCCode": "61957-3109-1",
"PackageDescription": "20 mL in 1 BOTTLE (61957-3109-1) ",
"NDC11Code": "61957-3109-01",
"ProductNDC": "61957-3109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Forever Skin Glow 24h Wear Radiant Foundation Perfection And Hydration Concentrated Floral Skincare With Suncreen Broad Spectrum Spf 15 6.5n",
"NonProprietaryName": "Octisalate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "45; 9.4",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions."
},
{
"NDCCode": "54868-3109-7",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (54868-3109-7)",
"NDC11Code": "54868-3109-07",
"ProductNDC": "54868-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration."
},
{
"NDCCode": "85512-3109-7",
"PackageDescription": "1000 g in 1 BAG (85512-3109-7) ",
"NDC11Code": "85512-3109-07",
"ProductNDC": "85512-3109",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Riboflavin 5 Phosphate Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Qinzeyuan Biotechnology Co., Ltd",
"SubstanceName": "RIBOFLAVIN 5'-PHOSPHATE SODIUM ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-02-05",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-JAN-25"
},
{
"NDCCode": "0093-3109-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0093-3109-01) ",
"NDC11Code": "00093-3109-01",
"ProductNDC": "0093-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250430",
"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 Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., 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 (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. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, 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": "0093-3109-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0093-3109-05) ",
"NDC11Code": "00093-3109-05",
"ProductNDC": "0093-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900930",
"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 Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., 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 (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. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, 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": "0093-3109-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0093-3109-06) ",
"NDC11Code": "00093-3109-06",
"ProductNDC": "0093-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250430",
"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 Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., 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 (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. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, 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": "0093-3109-53",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (0093-3109-53) ",
"NDC11Code": "00093-3109-53",
"ProductNDC": "0093-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900930",
"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 Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., 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 (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. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, 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": "48951-3109-2",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-3109-2) ",
"NDC11Code": "48951-3109-02",
"ProductNDC": "48951-3109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cocculus Conium",
"NonProprietaryName": "Cocculus Conium",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "ANAMIRTA COCCULUS WHOLE; CONIUM MACULATUM ROOT; AMBERGRIS; LIQUID PETROLEUM",
"StrengthNumber": "4; 4; 7; 9",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "54868-3109-0",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (54868-3109-0)",
"NDC11Code": "54868-3109-00",
"ProductNDC": "54868-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration."
},
{
"NDCCode": "54868-3109-1",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (54868-3109-1)",
"NDC11Code": "54868-3109-01",
"ProductNDC": "54868-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration."
},
{
"NDCCode": "54868-3109-2",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (54868-3109-2)",
"NDC11Code": "54868-3109-02",
"ProductNDC": "54868-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration."
},
{
"NDCCode": "54868-3109-3",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (54868-3109-3)",
"NDC11Code": "54868-3109-03",
"ProductNDC": "54868-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration."
},
{
"NDCCode": "54868-3109-5",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (54868-3109-5)",
"NDC11Code": "54868-3109-05",
"ProductNDC": "54868-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration."
},
{
"NDCCode": "54868-3109-6",
"PackageDescription": "9 CAPSULE in 1 BOTTLE (54868-3109-6)",
"NDC11Code": "54868-3109-06",
"ProductNDC": "54868-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration."
},
{
"NDCCode": "54868-3109-8",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (54868-3109-8)",
"NDC11Code": "54868-3109-08",
"ProductNDC": "54868-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration."
},
{
"NDCCode": "54868-3109-9",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (54868-3109-9)",
"NDC11Code": "54868-3109-09",
"ProductNDC": "54868-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration."
},
{
"NDCCode": "55789-3109-2",
"PackageDescription": "1 TUBE in 1 CARTON (55789-3109-2) / 60 mL in 1 TUBE",
"NDC11Code": "55789-3109-02",
"ProductNDC": "55789-3109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Spf 40 Moisturizer",
"NonProprietaryName": "Zinc Oxide And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121210",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Mineral Fusion brands",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "7.5; 5",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190917",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "70518-3109-0",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-3109-0) ",
"NDC11Code": "70518-3109-00",
"ProductNDC": "70518-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078956",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older:. Epilepsy—monotherapy in patients aged 16 years and older:Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder:Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pK aof 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine tablets USP are supplied for oral administration as 25 mg (white to off-white), 100 mg (peach), 150 mg (cream), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate; FD&C yellow No 6 (100 mg tablet only); ferric oxide yellow (150 mg tablet only); and FD&C blue No 2 lake (200 mg tablet only). Meets USP dissolution test 3."
},
{
"NDCCode": "70518-3109-1",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (70518-3109-1) ",
"NDC11Code": "70518-3109-01",
"ProductNDC": "70518-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078956",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210706",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older:. Epilepsy—monotherapy in patients aged 16 years and older:Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder:Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pK aof 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine tablets USP are supplied for oral administration as 25 mg (white to off-white), 100 mg (peach), 150 mg (cream), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate; FD&C yellow No 6 (100 mg tablet only); ferric oxide yellow (150 mg tablet only); and FD&C blue No 2 lake (200 mg tablet only). Meets USP dissolution test 3."
},
{
"NDCCode": "71335-3109-1",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (71335-3109-1) ",
"NDC11Code": "71335-3109-01",
"ProductNDC": "71335-3109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211314",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181017",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9 H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline powder with a pH of 6.5 – 7.5. It is freely soluble in water and sparingly soluble in methanol. Each gabapentin capsule contains 100 mg, 300mg or 400 mg of gabapentin and the following inactive ingredients. Corn starch, magnesium stearate, mannitol and talc. The 100mg capsule shell contains gelatin, titanium dioxide, and water. The 300mg capsule shell contains gelatin, iron oxide yellow, titanium dioxide and water. The 400mg capsule shell contains FD&C Blue #1, FD&C Yellow #6, gelatin, titanium dioxide and water. The imprinting ink Green Tek SB 4027 contains shellac, iron oxide yellow & FD & C Blue # 1 Aluminum Lake. The imprinting ink Blue Tek SB 6018 contains Shellac and FD & C Blue # 2 Aluminum Lake."
},
{
"NDCCode": "61957-1052-7",
"PackageDescription": "2 g in 1 TUBE (61957-1052-7)",
"NDC11Code": "61957-1052-07",
"ProductNDC": "61957-1052",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rouge Dior Serum De Rouge Luminous Color Lip Treatment 850",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100507",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "7.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "61957-1059-7",
"PackageDescription": "2 g in 1 PACKAGE (61957-1059-7)",
"NDC11Code": "61957-1059-07",
"ProductNDC": "61957-1059",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rouge Dior 850 Red Serum",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100605",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "7.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "61957-1090-1",
"PackageDescription": "7.2 g in 1 PACKAGE (61957-1090-1)",
"NDC11Code": "61957-1090-01",
"ProductNDC": "61957-1090",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cd Creme De Rose Plumping Lip Balm",
"NonProprietaryName": "Octinoxate, Avobenzone",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100611",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTINOXATE; AVOBENZONE",
"StrengthNumber": "7.5; 1",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "61957-2955-2",
"PackageDescription": ".7 mL in 1 PACKET (61957-2955-2) ",
"NDC11Code": "61957-2955-02",
"ProductNDC": "61957-2955",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Forever 24h Wear High Perfection Skin Caring Foundation With Sunscreen Broad Spectrum Spf 35 Lasting Comfort And Care",
"ProprietaryNameSuffix": "1n",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "PARFUMS CHRISTIAN DIOR",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 17.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions."
},
{
"NDCCode": "61957-2959-2",
"PackageDescription": ".7 mL in 1 PACKET (61957-2959-2) ",
"NDC11Code": "61957-2959-02",
"ProductNDC": "61957-2959",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Forever 24h Wear High Perfection Skin Caring Foundation With Sunscreen Broad Spectrum Spf 35 Lasting Comfort And Care",
"ProprietaryNameSuffix": "2n",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "PARFUMS CHRISTIAN DIOR",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 17.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions."
},
{
"NDCCode": "61957-2966-2",
"PackageDescription": ".7 mL in 1 PACKET (61957-2966-2) ",
"NDC11Code": "61957-2966-02",
"ProductNDC": "61957-2966",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Forever 24h Wear High Perfection Skin Caring Foundation With Sunscreen Broad Spectrum Spf 35 Lasting Comfort And Care",
"ProprietaryNameSuffix": "3n",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "PARFUMS CHRISTIAN DIOR",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 17.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions."
},
{
"NDCCode": "61957-2973-2",
"PackageDescription": ".7 mL in 1 PACKET (61957-2973-2) ",
"NDC11Code": "61957-2973-02",
"ProductNDC": "61957-2973",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Forever 24h Wear High Perfection Skin Caring Foundation With Sunscreen Broad Spectrum Spf 35 Lasting Comfort And Care",
"ProprietaryNameSuffix": "4n",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "PARFUMS CHRISTIAN DIOR",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 17.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions."
},
{
"NDCCode": "61957-3001-2",
"PackageDescription": "2.7 mL in 1 TUBE (61957-3001-2) ",
"NDC11Code": "61957-3001-02",
"ProductNDC": "61957-3001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Forever Transfer-proof - 24h Foundation High Perfection Concentrated Floral Skincare With Sunscreen Broad Spectrum Spf 15 9n",
"NonProprietaryName": "Octisalate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "35; 9.4",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>61957-3109-7</NDCCode>
<PackageDescription>.7 mL in 1 PACKET (61957-3109-7) </PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<StrengthNumber>45; 9.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61957-3109-0</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (61957-3109-0) </PackageDescription>
<NDC11Code>61957-3109-00</NDC11Code>
<ProductNDC>61957-3109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Forever Skin Glow 24h Wear Radiant Foundation Perfection And Hydration Concentrated Floral Skincare With Suncreen Broad Spectrum Spf 15 6.5n</ProprietaryName>
<NonProprietaryName>Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>45; 9.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61957-3109-1</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE (61957-3109-1) </PackageDescription>
<NDC11Code>61957-3109-01</NDC11Code>
<ProductNDC>61957-3109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Forever Skin Glow 24h Wear Radiant Foundation Perfection And Hydration Concentrated Floral Skincare With Suncreen Broad Spectrum Spf 15 6.5n</ProprietaryName>
<NonProprietaryName>Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>45; 9.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-3109-7</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (54868-3109-7)</PackageDescription>
<NDC11Code>54868-3109-07</NDC11Code>
<ProductNDC>54868-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>85512-3109-7</NDCCode>
<PackageDescription>1000 g in 1 BAG (85512-3109-7) </PackageDescription>
<NDC11Code>85512-3109-07</NDC11Code>
<ProductNDC>85512-3109</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Riboflavin 5 Phosphate Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Qinzeyuan Biotechnology Co., Ltd</LabelerName>
<SubstanceName>RIBOFLAVIN 5'-PHOSPHATE SODIUM ANHYDROUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-02-05</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0093-3109-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0093-3109-01) </PackageDescription>
<NDC11Code>00093-3109-01</NDC11Code>
<ProductNDC>0093-3109</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>Teva Pharmaceuticals USA, 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>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</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 Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., 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 (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. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, 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>0093-3109-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (0093-3109-05) </PackageDescription>
<NDC11Code>00093-3109-05</NDC11Code>
<ProductNDC>0093-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<ApplicationNumber>ANDA061926</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
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<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900930</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 Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., 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 (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. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, 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>0093-3109-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0093-3109-06) </PackageDescription>
<NDC11Code>00093-3109-06</NDC11Code>
<ProductNDC>0093-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061926</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, 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>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</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 Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., 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 (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. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, 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>0093-3109-53</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (0093-3109-53) </PackageDescription>
<NDC11Code>00093-3109-53</NDC11Code>
<ProductNDC>0093-3109</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>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900930</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 Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., 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 Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., 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 (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. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, 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>48951-3109-2</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-3109-2) </PackageDescription>
<NDC11Code>48951-3109-02</NDC11Code>
<ProductNDC>48951-3109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cocculus Conium</ProprietaryName>
<NonProprietaryName>Cocculus Conium</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>ANAMIRTA COCCULUS WHOLE; CONIUM MACULATUM ROOT; AMBERGRIS; LIQUID PETROLEUM</SubstanceName>
<StrengthNumber>4; 4; 7; 9</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-3109-0</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (54868-3109-0)</PackageDescription>
<NDC11Code>54868-3109-00</NDC11Code>
<ProductNDC>54868-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>54868-3109-1</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (54868-3109-1)</PackageDescription>
<NDC11Code>54868-3109-01</NDC11Code>
<ProductNDC>54868-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>54868-3109-2</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (54868-3109-2)</PackageDescription>
<NDC11Code>54868-3109-02</NDC11Code>
<ProductNDC>54868-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>54868-3109-3</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (54868-3109-3)</PackageDescription>
<NDC11Code>54868-3109-03</NDC11Code>
<ProductNDC>54868-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>54868-3109-5</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (54868-3109-5)</PackageDescription>
<NDC11Code>54868-3109-05</NDC11Code>
<ProductNDC>54868-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>54868-3109-6</NDCCode>
<PackageDescription>9 CAPSULE in 1 BOTTLE (54868-3109-6)</PackageDescription>
<NDC11Code>54868-3109-06</NDC11Code>
<ProductNDC>54868-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>54868-3109-8</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE (54868-3109-8)</PackageDescription>
<NDC11Code>54868-3109-08</NDC11Code>
<ProductNDC>54868-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>54868-3109-9</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (54868-3109-9)</PackageDescription>
<NDC11Code>54868-3109-09</NDC11Code>
<ProductNDC>54868-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (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. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>55789-3109-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (55789-3109-2) / 60 mL in 1 TUBE</PackageDescription>
<NDC11Code>55789-3109-02</NDC11Code>
<ProductNDC>55789-3109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Spf 40 Moisturizer</ProprietaryName>
<NonProprietaryName>Zinc Oxide And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Mineral Fusion brands</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.5; 5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70518-3109-0</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70518-3109-0) </PackageDescription>
<NDC11Code>70518-3109-00</NDC11Code>
<ProductNDC>70518-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078956</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older:. Epilepsy—monotherapy in patients aged 16 years and older:Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder:Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pK aof 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine tablets USP are supplied for oral administration as 25 mg (white to off-white), 100 mg (peach), 150 mg (cream), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate; FD&C yellow No 6 (100 mg tablet only); ferric oxide yellow (150 mg tablet only); and FD&C blue No 2 lake (200 mg tablet only). Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>70518-3109-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (70518-3109-1) </PackageDescription>
<NDC11Code>70518-3109-01</NDC11Code>
<ProductNDC>70518-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078956</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older:. Epilepsy—monotherapy in patients aged 16 years and older:Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder:Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pK aof 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine tablets USP are supplied for oral administration as 25 mg (white to off-white), 100 mg (peach), 150 mg (cream), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate; FD&C yellow No 6 (100 mg tablet only); ferric oxide yellow (150 mg tablet only); and FD&C blue No 2 lake (200 mg tablet only). Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>71335-3109-1</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (71335-3109-1) </PackageDescription>
<NDC11Code>71335-3109-01</NDC11Code>
<ProductNDC>71335-3109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211314</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9 H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline powder with a pH of 6.5 – 7.5. It is freely soluble in water and sparingly soluble in methanol. Each gabapentin capsule contains 100 mg, 300mg or 400 mg of gabapentin and the following inactive ingredients. Corn starch, magnesium stearate, mannitol and talc. The 100mg capsule shell contains gelatin, titanium dioxide, and water. The 300mg capsule shell contains gelatin, iron oxide yellow, titanium dioxide and water. The 400mg capsule shell contains FD&C Blue #1, FD&C Yellow #6, gelatin, titanium dioxide and water. The imprinting ink Green Tek SB 4027 contains shellac, iron oxide yellow & FD & C Blue # 1 Aluminum Lake. The imprinting ink Blue Tek SB 6018 contains Shellac and FD & C Blue # 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>61957-1052-7</NDCCode>
<PackageDescription>2 g in 1 TUBE (61957-1052-7)</PackageDescription>
<NDC11Code>61957-1052-07</NDC11Code>
<ProductNDC>61957-1052</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rouge Dior Serum De Rouge Luminous Color Lip Treatment 850</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100507</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>61957-1059-7</NDCCode>
<PackageDescription>2 g in 1 PACKAGE (61957-1059-7)</PackageDescription>
<NDC11Code>61957-1059-07</NDC11Code>
<ProductNDC>61957-1059</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rouge Dior 850 Red Serum</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100605</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>61957-1090-1</NDCCode>
<PackageDescription>7.2 g in 1 PACKAGE (61957-1090-1)</PackageDescription>
<NDC11Code>61957-1090-01</NDC11Code>
<ProductNDC>61957-1090</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cd Creme De Rose Plumping Lip Balm</ProprietaryName>
<NonProprietaryName>Octinoxate, Avobenzone</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100611</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE</SubstanceName>
<StrengthNumber>7.5; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>61957-2955-2</NDCCode>
<PackageDescription>.7 mL in 1 PACKET (61957-2955-2) </PackageDescription>
<NDC11Code>61957-2955-02</NDC11Code>
<ProductNDC>61957-2955</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Forever 24h Wear High Perfection Skin Caring Foundation With Sunscreen Broad Spectrum Spf 35 Lasting Comfort And Care</ProprietaryName>
<ProprietaryNameSuffix>1n</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>PARFUMS CHRISTIAN DIOR</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 17.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61957-2959-2</NDCCode>
<PackageDescription>.7 mL in 1 PACKET (61957-2959-2) </PackageDescription>
<NDC11Code>61957-2959-02</NDC11Code>
<ProductNDC>61957-2959</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Forever 24h Wear High Perfection Skin Caring Foundation With Sunscreen Broad Spectrum Spf 35 Lasting Comfort And Care</ProprietaryName>
<ProprietaryNameSuffix>2n</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>PARFUMS CHRISTIAN DIOR</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 17.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61957-2966-2</NDCCode>
<PackageDescription>.7 mL in 1 PACKET (61957-2966-2) </PackageDescription>
<NDC11Code>61957-2966-02</NDC11Code>
<ProductNDC>61957-2966</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Forever 24h Wear High Perfection Skin Caring Foundation With Sunscreen Broad Spectrum Spf 35 Lasting Comfort And Care</ProprietaryName>
<ProprietaryNameSuffix>3n</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>PARFUMS CHRISTIAN DIOR</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 17.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61957-2973-2</NDCCode>
<PackageDescription>.7 mL in 1 PACKET (61957-2973-2) </PackageDescription>
<NDC11Code>61957-2973-02</NDC11Code>
<ProductNDC>61957-2973</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Forever 24h Wear High Perfection Skin Caring Foundation With Sunscreen Broad Spectrum Spf 35 Lasting Comfort And Care</ProprietaryName>
<ProprietaryNameSuffix>4n</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>PARFUMS CHRISTIAN DIOR</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 17.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61957-3001-2</NDCCode>
<PackageDescription>2.7 mL in 1 TUBE (61957-3001-2) </PackageDescription>
<NDC11Code>61957-3001-02</NDC11Code>
<ProductNDC>61957-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Forever Transfer-proof - 24h Foundation High Perfection Concentrated Floral Skincare With Sunscreen Broad Spectrum Spf 15 9n</ProprietaryName>
<NonProprietaryName>Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>35; 9.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions.</IndicationAndUsage>
</NDC>
</NDCList>