{
"NDC": [
{
"NDCCode": "43598-003-54",
"PackageDescription": "200 mL in 1 BOTTLE (43598-003-54)",
"NDC11Code": "43598-0003-54",
"ProductNDC": "43598-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "Dr Reddys Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.",
"Description": "AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as."
},
{
"NDCCode": "43598-003-51",
"PackageDescription": "75 mL in 1 BOTTLE (43598-003-51)",
"NDC11Code": "43598-0003-51",
"ProductNDC": "43598-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "Dr Reddys Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.",
"Description": "AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as."
},
{
"NDCCode": "43598-003-69",
"PackageDescription": "125 mL in 1 BOTTLE (43598-003-69)",
"NDC11Code": "43598-0003-69",
"ProductNDC": "43598-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "Dr Reddys Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.",
"Description": "AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as."
},
{
"NDCCode": "58356-003-01",
"PackageDescription": "8806.54 L in 1 CYLINDER (58356-003-01) ",
"NDC11Code": "58356-0003-01",
"ProductNDC": "58356-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Air",
"NonProprietaryName": "Air",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20180418",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "Lampton Welding Supply Company, Inc",
"SubstanceName": "OXYGEN",
"StrengthNumber": "21",
"StrengthUnit": "L/L",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180418",
"SamplePackage": "N"
},
{
"NDCCode": "74168-003-54",
"PackageDescription": "30000 mL in 1 BOTTLE (74168-003-54) ",
"NDC11Code": "74168-0003-54",
"ProductNDC": "74168-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Gel",
"ProprietaryNameSuffix": "75% Alcohol",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Yasili Cosmetics Co. Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200408",
"SamplePackage": "N"
},
{
"NDCCode": "74790-003-03",
"PackageDescription": "4.54 L in 1 BOTTLE, PLASTIC (74790-003-03) ",
"NDC11Code": "74790-0003-03",
"ProductNDC": "74790-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Quimica Ervic, S.a. De C.v.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".25",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2020-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200513",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75613-003-01",
"PackageDescription": "54 mL in 1 BOTTLE (75613-003-01) ",
"NDC11Code": "75613-0003-01",
"ProductNDC": "75613-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200605",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Ningbo Lanzi Cosmetic Technology Co., Ltd",
"SubstanceName": "ALCOHOL",
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"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200605",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing."
},
{
"NDCCode": "81964-003-54",
"PackageDescription": "200 mL in 1 BOTTLE (81964-003-54) ",
"NDC11Code": "81964-0003-54",
"ProductNDC": "81964-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "USAntibiotics, LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220715",
"SamplePackage": "N",
"IndicationAndUsage": "AUGMENTIN ES-600 is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with. : 1 Recurrent or persistent acute otitis media due to S. pneumoniae(penicillin MICs less than or equal to 2 mcg/mL), H. influenzae(including beta-lactamase-producing strains), or M. catarrhalis(including beta-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)]. .",
"Description": "AUGMENTIN ES-600 is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum [see Warnings and Precautions (5.8)]. Each 5 mL of reconstituted AUGMENTIN ES-600 contains approximately 9 mg of potassium and 4 mg of sodium."
},
{
"NDCCode": "43598-203-54",
"PackageDescription": "200 mL in 1 BOTTLE (43598-203-54)",
"NDC11Code": "43598-0203-54",
"ProductNDC": "43598-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20010622",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "Dr Reddys Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43598-484-54",
"PackageDescription": "2 BOTTLE in 1 CARTON (43598-484-54) / 27 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0484-54",
"ProductNDC": "43598-484",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20200911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212983",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200911",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-485-54",
"PackageDescription": "2 BOTTLE in 1 CARTON (43598-485-54) / 27 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0485-54",
"ProductNDC": "43598-485",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20200911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212983",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200911",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
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"NDC11Code": "43598-0486-54",
"ProductNDC": "43598-486",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20200609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212796",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
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"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "20200609",
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"LabelerName": "Dr. Reddy's Laboratories Inc.",
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"StrengthUnit": "mg/1",
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"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-488-54",
"PackageDescription": "2 BOTTLE in 1 CARTON (43598-488-54) / 27 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0488-54",
"ProductNDC": "43598-488",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
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"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213233",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
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"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
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"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-258-11",
"PackageDescription": "1 mL in 1 VIAL, GLASS (43598-258-11) ",
"NDC11Code": "43598-0258-11",
"ProductNDC": "43598-258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204193",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DOCETAXEL",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141110",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C43H53NO14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP. Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous). Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "43598-259-40",
"PackageDescription": "4 mL in 1 VIAL, GLASS (43598-259-40) ",
"NDC11Code": "43598-0259-40",
"ProductNDC": "43598-259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204193",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "80",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141110",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C43H53NO14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP. Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous). Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "43598-389-57",
"PackageDescription": "8 mL in 1 VIAL, GLASS (43598-389-57) ",
"NDC11Code": "43598-0389-57",
"ProductNDC": "43598-389",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204193",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "160",
"StrengthUnit": "mg/8mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190422",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C43H53NO14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP. Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous). Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "43598-438-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-438-01) ",
"NDC11Code": "43598-0438-01",
"ProductNDC": "43598-438",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213473",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200820",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid. In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide). Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol."
},
{
"NDCCode": "43598-439-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-439-01) ",
"NDC11Code": "43598-0439-01",
"ProductNDC": "43598-439",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213473",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "27",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200820",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid. In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide). Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol."
},
{
"NDCCode": "43598-440-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-440-01) ",
"NDC11Code": "43598-0440-01",
"ProductNDC": "43598-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200820",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213473",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20260930",
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"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid. In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide). Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol. \"Meets USP Dissolution Test 12\"."
},
{
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"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-441-01) ",
"NDC11Code": "43598-0441-01",
"ProductNDC": "43598-441",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213473",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "54",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200820",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid. In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide). Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol."
},
{
"NDCCode": "43598-610-40",
"PackageDescription": "4 mL in 1 VIAL, GLASS (43598-610-40) ",
"NDC11Code": "43598-0610-40",
"ProductNDC": "43598-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204193",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "80",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170822",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C43H53NO14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP. Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous). Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "43598-611-11",
"PackageDescription": "1 mL in 1 VIAL, GLASS (43598-611-11) ",
"NDC11Code": "43598-0611-11",
"ProductNDC": "43598-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204193",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170822",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C43H53NO14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP. Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous). Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "43598-909-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43598-909-90) ",
"NDC11Code": "43598-0909-90",
"ProductNDC": "43598-909",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210670",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "54",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200131",
"SamplePackage": "N",
"Description": "Fenofibrate Tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, d & c yellow#10 aluminum lake (only 54 mg tablets), lactose monohydrate, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone k30, pregelatinized maize starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, xanthan gum. Fenofibrate Tablets, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "43598-910-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-910-05) ",
"NDC11Code": "43598-0910-05",
"ProductNDC": "43598-910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210670",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200131",
"SamplePackage": "N",
"Description": "Fenofibrate Tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, d & c yellow#10 aluminum lake (only 54 mg tablets), lactose monohydrate, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone k30, pregelatinized maize starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, xanthan gum. Fenofibrate Tablets, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "43598-910-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43598-910-90) ",
"NDC11Code": "43598-0910-90",
"ProductNDC": "43598-910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210670",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200131",
"SamplePackage": "N",
"Description": "Fenofibrate Tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, d & c yellow#10 aluminum lake (only 54 mg tablets), lactose monohydrate, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone k30, pregelatinized maize starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, xanthan gum. Fenofibrate Tablets, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "21749-135-54",
"PackageDescription": "208000 mL in 1 PACKAGE (21749-135-54) ",
"NDC11Code": "21749-0135-54",
"ProductNDC": "21749-135",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gojo E2 Sanitizing Ltn Sp",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040917",
"EndMarketingDate": "20220530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".003",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040917",
"EndMarketingDatePackage": "20220530",
"SamplePackage": "N"
},
{
"NDCCode": "70133-003-01",
"PackageDescription": "27 g in 1 PACKAGE (70133-003-01)",
"NDC11Code": "70133-0003-01",
"ProductNDC": "70133-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Niveola P.h.c 3d Festival Mask Pack",
"NonProprietaryName": "Niacinamide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151008",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Unisource International Co., Ltd.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": ".54",
"StrengthUnit": "g/27g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Improves brightness of skin."
},
{
"NDCCode": "70976-003-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (70976-003-02) > 12 g in 1 CONTAINER (70976-003-01)",
"NDC11Code": "70976-0003-02",
"ProductNDC": "70976-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Klavuu Bluepearlsation High Coverage Marine Collagen Aqua Cushion 21",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161212",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bekeikorea",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE",
"StrengthNumber": "1.06; .84; .59; .54",
"StrengthUnit": "g/12g; g/12g; g/12g; g/12g",
"Status": "Deprecated",
"LastUpdate": "2021-12-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>43598-003-54</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (43598-003-54)</PackageDescription>
<NDC11Code>43598-0003-54</NDC11Code>
<ProductNDC>43598-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin Es-600</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050755</ApplicationNumber>
<LabelerName>Dr Reddys Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.</IndicationAndUsage>
<Description>AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as.</Description>
</NDC>
<NDC>
<NDCCode>43598-003-51</NDCCode>
<PackageDescription>75 mL in 1 BOTTLE (43598-003-51)</PackageDescription>
<NDC11Code>43598-0003-51</NDC11Code>
<ProductNDC>43598-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin Es-600</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050755</ApplicationNumber>
<LabelerName>Dr Reddys Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.</IndicationAndUsage>
<Description>AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as.</Description>
</NDC>
<NDC>
<NDCCode>43598-003-69</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (43598-003-69)</PackageDescription>
<NDC11Code>43598-0003-69</NDC11Code>
<ProductNDC>43598-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin Es-600</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050755</ApplicationNumber>
<LabelerName>Dr Reddys Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.</IndicationAndUsage>
<Description>AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as.</Description>
</NDC>
<NDC>
<NDCCode>58356-003-01</NDCCode>
<PackageDescription>8806.54 L in 1 CYLINDER (58356-003-01) </PackageDescription>
<NDC11Code>58356-0003-01</NDC11Code>
<ProductNDC>58356-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Air</ProprietaryName>
<NonProprietaryName>Air</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20180418</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>Lampton Welding Supply Company, Inc</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>L/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74168-003-54</NDCCode>
<PackageDescription>30000 mL in 1 BOTTLE (74168-003-54) </PackageDescription>
<NDC11Code>74168-0003-54</NDC11Code>
<ProductNDC>74168-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Gel</ProprietaryName>
<ProprietaryNameSuffix>75% Alcohol</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Yasili Cosmetics Co. Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74790-003-03</NDCCode>
<PackageDescription>4.54 L in 1 BOTTLE, PLASTIC (74790-003-03) </PackageDescription>
<NDC11Code>74790-0003-03</NDC11Code>
<ProductNDC>74790-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Quimica Ervic, S.a. De C.v.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75613-003-01</NDCCode>
<PackageDescription>54 mL in 1 BOTTLE (75613-003-01) </PackageDescription>
<NDC11Code>75613-0003-01</NDC11Code>
<ProductNDC>75613-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200605</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Ningbo Lanzi Cosmetic Technology Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81964-003-54</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (81964-003-54) </PackageDescription>
<NDC11Code>81964-0003-54</NDC11Code>
<ProductNDC>81964-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin Es-600</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050755</ApplicationNumber>
<LabelerName>USAntibiotics, LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AUGMENTIN ES-600 is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with. : 1 Recurrent or persistent acute otitis media due to S. pneumoniae(penicillin MICs less than or equal to 2 mcg/mL), H. influenzae(including beta-lactamase-producing strains), or M. catarrhalis(including beta-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)]. .</IndicationAndUsage>
<Description>AUGMENTIN ES-600 is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8H 8KNO 5and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)-( 2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, colloidal silicon dioxide, silicon dioxide, sodium carboxymethylcellulose, strawberry cream flavor, and xanthan gum [see Warnings and Precautions (5.8)]. Each 5 mL of reconstituted AUGMENTIN ES-600 contains approximately 9 mg of potassium and 4 mg of sodium.</Description>
</NDC>
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<NDCCode>43598-203-54</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (43598-203-54)</PackageDescription>
<NDC11Code>43598-0203-54</NDC11Code>
<ProductNDC>43598-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010622</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050755</ApplicationNumber>
<LabelerName>Dr Reddys Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43598-484-54</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (43598-484-54) / 27 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0484-54</NDC11Code>
<ProductNDC>43598-484</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212983</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-485-54</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (43598-485-54) / 27 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0485-54</NDC11Code>
<ProductNDC>43598-485</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212983</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-486-54</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (43598-486-54) / 27 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0486-54</NDC11Code>
<ProductNDC>43598-486</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212796</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-487-54</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (43598-487-54) / 27 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0487-54</NDC11Code>
<ProductNDC>43598-487</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212796</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-488-54</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (43598-488-54) / 27 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0488-54</NDC11Code>
<ProductNDC>43598-488</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213233</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-489-54</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (43598-489-54) / 27 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0489-54</NDC11Code>
<ProductNDC>43598-489</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213233</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-258-11</NDCCode>
<PackageDescription>1 mL in 1 VIAL, GLASS (43598-258-11) </PackageDescription>
<NDC11Code>43598-0258-11</NDC11Code>
<ProductNDC>43598-258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20141110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204193</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C43H53NO14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP. Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous). Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>43598-259-40</NDCCode>
<PackageDescription>4 mL in 1 VIAL, GLASS (43598-259-40) </PackageDescription>
<NDC11Code>43598-0259-40</NDC11Code>
<ProductNDC>43598-259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20141110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204193</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C43H53NO14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP. Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous). Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>43598-389-57</NDCCode>
<PackageDescription>8 mL in 1 VIAL, GLASS (43598-389-57) </PackageDescription>
<NDC11Code>43598-0389-57</NDC11Code>
<ProductNDC>43598-389</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204193</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/8mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C43H53NO14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP. Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous). Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>43598-438-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-438-01) </PackageDescription>
<NDC11Code>43598-0438-01</NDC11Code>
<ProductNDC>43598-438</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213473</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid. In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide). Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>43598-439-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-439-01) </PackageDescription>
<NDC11Code>43598-0439-01</NDC11Code>
<ProductNDC>43598-439</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213473</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>27</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid. In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide). Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol.</Description>
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<NDC>
<NDCCode>43598-440-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-440-01) </PackageDescription>
<NDC11Code>43598-0440-01</NDC11Code>
<ProductNDC>43598-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200820</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213473</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>36</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200820</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid. In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide). Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol. "Meets USP Dissolution Test 12".</Description>
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<NDCCode>43598-441-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-441-01) </PackageDescription>
<NDC11Code>43598-0441-01</NDC11Code>
<ProductNDC>43598-441</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213473</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>54</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid. In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide). Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol.</Description>
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<NDC>
<NDCCode>43598-610-40</NDCCode>
<PackageDescription>4 mL in 1 VIAL, GLASS (43598-610-40) </PackageDescription>
<NDC11Code>43598-0610-40</NDC11Code>
<ProductNDC>43598-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204193</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C43H53NO14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP. Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous). Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
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<NDCCode>43598-611-11</NDCCode>
<PackageDescription>1 mL in 1 VIAL, GLASS (43598-611-11) </PackageDescription>
<NDC11Code>43598-0611-11</NDC11Code>
<ProductNDC>43598-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204193</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C43H53NO14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP. Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous). Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
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<NDC>
<NDCCode>43598-909-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (43598-909-90) </PackageDescription>
<NDC11Code>43598-0909-90</NDC11Code>
<ProductNDC>43598-909</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210670</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>54</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Fenofibrate Tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, d & c yellow#10 aluminum lake (only 54 mg tablets), lactose monohydrate, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone k30, pregelatinized maize starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, xanthan gum. Fenofibrate Tablets, USP meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-910-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-910-05) </PackageDescription>
<NDC11Code>43598-0910-05</NDC11Code>
<ProductNDC>43598-910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210670</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Fenofibrate Tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, d & c yellow#10 aluminum lake (only 54 mg tablets), lactose monohydrate, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone k30, pregelatinized maize starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, xanthan gum. Fenofibrate Tablets, USP meets USP Dissolution Test 2.</Description>
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<NDCCode>43598-910-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (43598-910-90) </PackageDescription>
<NDC11Code>43598-0910-90</NDC11Code>
<ProductNDC>43598-910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210670</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Fenofibrate Tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, d & c yellow#10 aluminum lake (only 54 mg tablets), lactose monohydrate, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone k30, pregelatinized maize starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, xanthan gum. Fenofibrate Tablets, USP meets USP Dissolution Test 2.</Description>
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<NDCCode>21749-135-54</NDCCode>
<PackageDescription>208000 mL in 1 PACKAGE (21749-135-54) </PackageDescription>
<NDC11Code>21749-0135-54</NDC11Code>
<ProductNDC>21749-135</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gojo E2 Sanitizing Ltn Sp</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040917</StartMarketingDate>
<EndMarketingDate>20220530</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.003</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20040917</StartMarketingDatePackage>
<EndMarketingDatePackage>20220530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>70133-003-01</NDCCode>
<PackageDescription>27 g in 1 PACKAGE (70133-003-01)</PackageDescription>
<NDC11Code>70133-0003-01</NDC11Code>
<ProductNDC>70133-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Niveola P.h.c 3d Festival Mask Pack</ProprietaryName>
<NonProprietaryName>Niacinamide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151008</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Unisource International Co., Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>.54</StrengthNumber>
<StrengthUnit>g/27g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Improves brightness of skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70976-003-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (70976-003-02) > 12 g in 1 CONTAINER (70976-003-01)</PackageDescription>
<NDC11Code>70976-0003-02</NDC11Code>
<ProductNDC>70976-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Klavuu Bluepearlsation High Coverage Marine Collagen Aqua Cushion 21</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bekeikorea</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE</SubstanceName>
<StrengthNumber>1.06; .84; .59; .54</StrengthNumber>
<StrengthUnit>g/12g; g/12g; g/12g; g/12g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>