{
"NDC": [
{
"NDCCode": "68428-446-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-446-12) ",
"NDC11Code": "68428-0446-12",
"ProductNDC": "68428-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Juglans Regia",
"NonProprietaryName": "Juglans Regia Fruit Rind, Immature, Juglans Regia Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF",
"StrengthNumber": "30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "68428-446-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-446-03) ",
"NDC11Code": "68428-0446-03",
"ProductNDC": "68428-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Juglans Regia",
"NonProprietaryName": "Juglans Regia Fruit Rind, Immature, Juglans Regia Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF",
"StrengthNumber": "30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "68428-446-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-446-05) ",
"NDC11Code": "68428-0446-05",
"ProductNDC": "68428-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Juglans Regia",
"NonProprietaryName": "Juglans Regia Fruit Rind, Immature, Juglans Regia Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF",
"StrengthNumber": "30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "68428-446-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-446-06) ",
"NDC11Code": "68428-0446-06",
"ProductNDC": "68428-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Juglans Regia",
"NonProprietaryName": "Juglans Regia Fruit Rind, Immature, Juglans Regia Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF",
"StrengthNumber": "30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "68428-446-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-446-11) ",
"NDC11Code": "68428-0446-11",
"ProductNDC": "68428-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Juglans Regia",
"NonProprietaryName": "Juglans Regia Fruit Rind, Immature, Juglans Regia Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF",
"StrengthNumber": "30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "36800-446-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (36800-446-02) > 12 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "36800-0446-02",
"ProductNDC": "36800-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Chlorpheniramine Maleate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161101",
"EndMarketingDate": "20220630",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "TopCare",
"SubstanceName": "CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161101",
"EndMarketingDatePackage": "20220630",
"SamplePackage": "N"
},
{
"NDCCode": "50580-446-01",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (50580-446-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50580-0446-01",
"ProductNDC": "50580-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Tylenol Severe Cough Plus Sore Throat Day",
"NonProprietaryName": "Acetaminophen And Dextromethorphan Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240826",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN",
"StrengthNumber": "15; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240826",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: minor aches and painsheadachesore throatcough. temporarily reduces fever."
},
{
"NDCCode": "52685-446-30",
"PackageDescription": "1 TRAY in 1 CARTON (52685-446-30) > 12 g in 1 TRAY",
"NDC11Code": "52685-0446-30",
"ProductNDC": "52685-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Advanced Hydro-liquid Compact (refill)",
"ProprietaryNameSuffix": "I40",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".54",
"StrengthUnit": "g/12g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "55289-446-12",
"PackageDescription": "12 CAPSULE in 1 BOTTLE, PLASTIC (55289-446-12)",
"NDC11Code": "55289-0446-12",
"ProductNDC": "55289-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "55301-446-08",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (55301-446-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55301-0446-08",
"ProductNDC": "55301-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Headache And Pain",
"ProprietaryNameSuffix": "Day, Non-drowsy",
"NonProprietaryName": "Acetaminophen, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050726",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050726",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:minor aches and painsheadachenasal congestionsinus congestion and pressure. helps decongest sinus openings and passages. promotes sinus drainage. helps clear nasal passages. temporarily reduces fever."
},
{
"NDCCode": "58411-446-30",
"PackageDescription": "1 CONTAINER in 1 CARTON (58411-446-30) > 12 g in 1 CONTAINER",
"NDC11Code": "58411-0446-30",
"ProductNDC": "58411-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Sports Hydrobb Compact",
"ProprietaryNameSuffix": "Medium",
"NonProprietaryName": "Octinoxate, Octocrylene, And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE",
"StrengthNumber": "588; 360; 1608",
"StrengthUnit": "mg/12g; mg/12g; mg/12g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "60751-446-01",
"PackageDescription": "1 PATCH in 1 POUCH (60751-446-01) > 12 h in 1 PATCH",
"NDC11Code": "60751-0446-01",
"ProductNDC": "60751-446",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Nicotine",
"DosageFormName": "PATCH",
"StartMarketingDate": "19911127",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "LTS Lohmann Therapy Systems, Corp.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "7",
"StrengthUnit": "mg/24h",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "70756-446-12",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (70756-446-12) ",
"NDC11Code": "70756-0446-12",
"ProductNDC": "70756-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extended Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219773",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260320",
"SamplePackage": "N",
"IndicationAndUsage": "Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.",
"Description": "Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula. Each 100 mg extended phenytoin sodium capsule, USP for oral administration contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, lactose monohydrate, magnesium stearate, and talc. In addition, the empty hard gelatin capsule shells also contain gelatin and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide, potassium hydroxide, and shellac. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. FDA approved dissolution specifications for Extended Phenytoin Sodium Capsules, USP, 100 mg differs from the dissolution specifications in the USP."
},
{
"NDCCode": "0264-3112-11",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-3112-11) > 50 mL in 1 CONTAINER",
"NDC11Code": "00264-3112-11",
"ProductNDC": "0264-3112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime And Dextrose",
"NonProprietaryName": "Cefuroxime And Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010221",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050780",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "CEFUROXIME SODIUM",
"StrengthNumber": "750",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2020-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010221",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. , 3 Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. , 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase producing strains).",
"Description": "Cefuroxime for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single use, packaged combination of Cefuroxime Sodium USP (crystalline) and Dextrose Injection USP (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with sterile crystalline Cefuroxime for Injection USP, a semi-synthetic, broad-spectrum, cephalosporin antibacterial for parenteral administration. It is the sodium salt of (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), carbamate (ester). Cefuroxime Sodium USP has the following structural formula. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. The diluent chamber contains Dextrose Injection USP. The concentration of Hydrous Dextrose USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula. The molecular weight of Hydrous Dextrose USP is 198.17. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 2.05 g and 1.45 g to 750 mg and 1.5 g dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality of the reconstituted solution for Cefuroxime for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. Not made with natural rubber latex, PVC or Di (2-ethylhexyl) phthalate (DEHP). The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures."
},
{
"NDCCode": "0264-3114-11",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-3114-11) > 50 mL in 1 CONTAINER",
"NDC11Code": "00264-3114-11",
"ProductNDC": "0264-3114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime And Dextrose",
"NonProprietaryName": "Cefuroxime And Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010221",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050780",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "CEFUROXIME SODIUM",
"StrengthNumber": "1.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2020-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010221",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. , 3 Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. , 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase producing strains).",
"Description": "Cefuroxime for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single use, packaged combination of Cefuroxime Sodium USP (crystalline) and Dextrose Injection USP (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with sterile crystalline Cefuroxime for Injection USP, a semi-synthetic, broad-spectrum, cephalosporin antibacterial for parenteral administration. It is the sodium salt of (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), carbamate (ester). Cefuroxime Sodium USP has the following structural formula. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. The diluent chamber contains Dextrose Injection USP. The concentration of Hydrous Dextrose USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula. The molecular weight of Hydrous Dextrose USP is 198.17. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 2.05 g and 1.45 g to 750 mg and 1.5 g dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality of the reconstituted solution for Cefuroxime for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. Not made with natural rubber latex, PVC or Di (2-ethylhexyl) phthalate (DEHP). The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures."
},
{
"NDCCode": "0456-0400-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01) ",
"NDC11Code": "00456-0400-10",
"ProductNDC": "0456-0400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teflaro",
"NonProprietaryName": "Ceftaroline Fosamil",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20101029",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200327",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CEFTAROLINE FOSAMIL",
"StrengthNumber": "400",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101029",
"SamplePackage": "N",
"IndicationAndUsage": "Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).",
"Description": "TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5."
},
{
"NDCCode": "0456-0600-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01) ",
"NDC11Code": "00456-0600-10",
"ProductNDC": "0456-0600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teflaro",
"NonProprietaryName": "Ceftaroline Fosamil",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20101029",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200327",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CEFTAROLINE FOSAMIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101029",
"SamplePackage": "N",
"IndicationAndUsage": "Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).",
"Description": "TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5."
},
{
"NDCCode": "16781-446-35",
"PackageDescription": "1 TUBE in 1 CARTON (16781-446-35) > 35 g in 1 TUBE",
"NDC11Code": "16781-0446-35",
"ProductNDC": "16781-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretin.x",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202209",
"LabelerName": "Onset Dermatologics LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".75",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "25021-182-66",
"PackageDescription": "25 VIAL in 1 CARTON (25021-182-66) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "25021-0182-66",
"ProductNDC": "25021-182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Sodium",
"NonProprietaryName": "Cefuroxime Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20160901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064125",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "CEFUROXIME SODIUM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160901",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: : 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp., 3 Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp., 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non- penicillinase-producing strains). .",
"Description": "Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl) acetamido] ceph-3-em-4-carboxylate, and it has the following chemical structure:. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for Injection, USP in sterile crystalline form is supplied in vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for Injection, USP range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5."
},
{
"NDCCode": "25021-183-67",
"PackageDescription": "25 VIAL in 1 CARTON (25021-183-67) > 16 mL in 1 VIAL",
"NDC11Code": "25021-0183-67",
"ProductNDC": "25021-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Sodium",
"NonProprietaryName": "Cefuroxime Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064125",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "CEFUROXIME SODIUM",
"StrengthNumber": "1.5",
"StrengthUnit": "g/16mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160901",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: : 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp., 3 Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp., 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non- penicillinase-producing strains). .",
"Description": "Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl) acetamido] ceph-3-em-4-carboxylate, and it has the following chemical structure:. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for Injection, USP in sterile crystalline form is supplied in vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for Injection, USP range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5."
},
{
"NDCCode": "35573-446-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-446-30) ",
"NDC11Code": "35573-0446-30",
"ProductNDC": "35573-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trospium Chloride Er",
"NonProprietaryName": "Trospium Chloride Er",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213185",
"LabelerName": "35573",
"SubstanceName": "TROSPIUM CHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210805",
"SamplePackage": "N",
"IndicationAndUsage": "Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8- azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C 25H 30ClNO 3 and its molecular weight is 428. The structural formula of trospium chloride is represented below:. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g/2 mL. Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients: corn starch, ethylcellulose, FD&C Blue# 1, FD&C Red# 40, FD&C Yellow# 6, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triacetin and triethyl citrate. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "37000-446-24",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (37000-446-24) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "37000-0446-24",
"ProductNDC": "37000-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pepto",
"ProprietaryNameSuffix": "Kids",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20050720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180121",
"SamplePackage": "N"
},
{
"NDCCode": "37000-446-72",
"PackageDescription": "3 CARTON in 1 CELLO PACK (37000-446-72) / 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "37000-0446-72",
"ProductNDC": "37000-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pepto",
"ProprietaryNameSuffix": "Kids",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20050720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20050720",
"SamplePackage": "N"
},
{
"NDCCode": "37205-446-52",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (37205-446-52) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "37205-0446-52",
"ProductNDC": "37205-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader 12 Hour Nasal Decongestant",
"NonProprietaryName": "Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19990721",
"EndMarketingDate": "20191101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075153",
"LabelerName": "Cardinal Health",
"SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990721",
"EndMarketingDatePackage": "20191101",
"SamplePackage": "N"
},
{
"NDCCode": "37808-446-68",
"PackageDescription": "36 BLISTER PACK in 1 CARTON (37808-446-68) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "37808-0446-68",
"ProductNDC": "37808-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief D",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091071",
"LabelerName": "H E B",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160322",
"SamplePackage": "N"
},
{
"NDCCode": "37808-446-89",
"PackageDescription": "18 BLISTER PACK in 1 CARTON (37808-446-89) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "37808-0446-89",
"ProductNDC": "37808-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief D",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091071",
"LabelerName": "H E B",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160322",
"SamplePackage": "N"
},
{
"NDCCode": "42291-446-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-446-30) ",
"NDC11Code": "42291-0446-30",
"ProductNDC": "42291-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207497",
"LabelerName": "AvKARE",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200522",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. (1.2) .",
"Description": "Lamotrigine, USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine USP, is a white to pale cream-colored powder and has a pK a of 5.7. Lamotrigine USP, is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets USP, are supplied for oral administration as 25 mg (yellow), 50 mg (green), 100 mg (beige), 200 mg (blue), 250 mg (purple) and 300 mg (gray) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, macrogol, magnesium stearate, methacrylic acid copolymer dispersion, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 25 mg tablets also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 50 mg tablets also contain FD&C Blue No. 2 and iron oxide yellow. The 100 mg tablets also contain iron oxide red and iron oxide yellow. The 200 mg tablets also contain FD&C Blue No. 2. The 250 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40. The 300 mg tablets also contain black iron oxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The core tablets are coated with an enteric coat and have pore forming ingredient in the coat to enable a controlled release of the drug in the acidic environment of the stomach. The combinations of the modified-release core and the enteric coat are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. USP Dissolution Test pending."
},
{
"NDCCode": "42658-105-04",
"PackageDescription": "90 TABLET in 1 BOTTLE (42658-105-04) ",
"NDC11Code": "42658-0105-04",
"ProductNDC": "42658-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206061",
"LabelerName": "Hisun Pharmaceuiticals USA, Inc",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate."
},
{
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{
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"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate."
}
]
}
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<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<LastUpdate>2024-12-27</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
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<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Lifestar Pharma LLC</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.</IndicationAndUsage>
<Description>Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula. Each 100 mg extended phenytoin sodium capsule, USP for oral administration contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, lactose monohydrate, magnesium stearate, and talc. In addition, the empty hard gelatin capsule shells also contain gelatin and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide, potassium hydroxide, and shellac. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. FDA approved dissolution specifications for Extended Phenytoin Sodium Capsules, USP, 100 mg differs from the dissolution specifications in the USP.</Description>
</NDC>
<NDC>
<NDCCode>0264-3112-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-3112-11) > 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-3112-11</NDC11Code>
<ProductNDC>0264-3112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime And Dextrose</ProprietaryName>
<NonProprietaryName>Cefuroxime And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010221</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050780</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>CEFUROXIME SODIUM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. , 3 Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. , 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase producing strains).</IndicationAndUsage>
<Description>Cefuroxime for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single use, packaged combination of Cefuroxime Sodium USP (crystalline) and Dextrose Injection USP (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with sterile crystalline Cefuroxime for Injection USP, a semi-synthetic, broad-spectrum, cephalosporin antibacterial for parenteral administration. It is the sodium salt of (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), carbamate (ester). Cefuroxime Sodium USP has the following structural formula. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. The diluent chamber contains Dextrose Injection USP. The concentration of Hydrous Dextrose USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula. The molecular weight of Hydrous Dextrose USP is 198.17. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 2.05 g and 1.45 g to 750 mg and 1.5 g dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality of the reconstituted solution for Cefuroxime for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. Not made with natural rubber latex, PVC or Di (2-ethylhexyl) phthalate (DEHP). The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
</NDC>
<NDC>
<NDCCode>0264-3114-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-3114-11) > 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-3114-11</NDC11Code>
<ProductNDC>0264-3114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime And Dextrose</ProprietaryName>
<NonProprietaryName>Cefuroxime And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010221</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050780</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>CEFUROXIME SODIUM</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. , 3 Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. , 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase producing strains).</IndicationAndUsage>
<Description>Cefuroxime for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single use, packaged combination of Cefuroxime Sodium USP (crystalline) and Dextrose Injection USP (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with sterile crystalline Cefuroxime for Injection USP, a semi-synthetic, broad-spectrum, cephalosporin antibacterial for parenteral administration. It is the sodium salt of (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), carbamate (ester). Cefuroxime Sodium USP has the following structural formula. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. The diluent chamber contains Dextrose Injection USP. The concentration of Hydrous Dextrose USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula. The molecular weight of Hydrous Dextrose USP is 198.17. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 2.05 g and 1.45 g to 750 mg and 1.5 g dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality of the reconstituted solution for Cefuroxime for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. Not made with natural rubber latex, PVC or Di (2-ethylhexyl) phthalate (DEHP). The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
</NDC>
<NDC>
<NDCCode>0456-0400-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01) </PackageDescription>
<NDC11Code>00456-0400-10</NDC11Code>
<ProductNDC>0456-0400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teflaro</ProprietaryName>
<NonProprietaryName>Ceftaroline Fosamil</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20101029</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200327</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CEFTAROLINE FOSAMIL</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).</IndicationAndUsage>
<Description>TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>0456-0600-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01) </PackageDescription>
<NDC11Code>00456-0600-10</NDC11Code>
<ProductNDC>0456-0600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teflaro</ProprietaryName>
<NonProprietaryName>Ceftaroline Fosamil</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20101029</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200327</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CEFTAROLINE FOSAMIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).</IndicationAndUsage>
<Description>TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>16781-446-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16781-446-35) > 35 g in 1 TUBE</PackageDescription>
<NDC11Code>16781-0446-35</NDC11Code>
<ProductNDC>16781-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretin.x</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202209</ApplicationNumber>
<LabelerName>Onset Dermatologics LLC</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>25021-182-66</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (25021-182-66) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>25021-0182-66</NDC11Code>
<ProductNDC>25021-182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Sodium</ProprietaryName>
<NonProprietaryName>Cefuroxime Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20160901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064125</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>CEFUROXIME SODIUM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: : 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp., 3 Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp., 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non- penicillinase-producing strains). .</IndicationAndUsage>
<Description>Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl) acetamido] ceph-3-em-4-carboxylate, and it has the following chemical structure:. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for Injection, USP in sterile crystalline form is supplied in vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for Injection, USP range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>25021-183-67</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (25021-183-67) > 16 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0183-67</NDC11Code>
<ProductNDC>25021-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Sodium</ProprietaryName>
<NonProprietaryName>Cefuroxime Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064125</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>CEFUROXIME SODIUM</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/16mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: : 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp., 3 Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp., 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non- penicillinase-producing strains). .</IndicationAndUsage>
<Description>Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl) acetamido] ceph-3-em-4-carboxylate, and it has the following chemical structure:. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for Injection, USP in sterile crystalline form is supplied in vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for Injection, USP range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>35573-446-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (35573-446-30) </PackageDescription>
<NDC11Code>35573-0446-30</NDC11Code>
<ProductNDC>35573-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trospium Chloride Er</ProprietaryName>
<NonProprietaryName>Trospium Chloride Er</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213185</ApplicationNumber>
<LabelerName>35573</LabelerName>
<SubstanceName>TROSPIUM CHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8- azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C 25H 30ClNO 3 and its molecular weight is 428. The structural formula of trospium chloride is represented below:. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g/2 mL. Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients: corn starch, ethylcellulose, FD&C Blue# 1, FD&C Red# 40, FD&C Yellow# 6, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triacetin and triethyl citrate. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>37000-446-24</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (37000-446-24) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>37000-0446-24</NDC11Code>
<ProductNDC>37000-446</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pepto</ProprietaryName>
<ProprietaryNameSuffix>Kids</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37000-446-72</NDCCode>
<PackageDescription>3 CARTON in 1 CELLO PACK (37000-446-72) / 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>37000-0446-72</NDC11Code>
<ProductNDC>37000-446</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pepto</ProprietaryName>
<ProprietaryNameSuffix>Kids</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37205-446-52</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (37205-446-52) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37205-0446-52</NDC11Code>
<ProductNDC>37205-446</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader 12 Hour Nasal Decongestant</ProprietaryName>
<NonProprietaryName>Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990721</StartMarketingDate>
<EndMarketingDate>20191101</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075153</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990721</StartMarketingDatePackage>
<EndMarketingDatePackage>20191101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37808-446-68</NDCCode>
<PackageDescription>36 BLISTER PACK in 1 CARTON (37808-446-68) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37808-0446-68</NDC11Code>
<ProductNDC>37808-446</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief D</ProprietaryName>
<NonProprietaryName>Guaifenesin, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091071</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37808-446-89</NDCCode>
<PackageDescription>18 BLISTER PACK in 1 CARTON (37808-446-89) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37808-0446-89</NDC11Code>
<ProductNDC>37808-446</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief D</ProprietaryName>
<NonProprietaryName>Guaifenesin, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091071</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-446-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-446-30) </PackageDescription>
<NDC11Code>42291-0446-30</NDC11Code>
<ProductNDC>42291-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207497</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. (1.2) .</IndicationAndUsage>
<Description>Lamotrigine, USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine USP, is a white to pale cream-colored powder and has a pK a of 5.7. Lamotrigine USP, is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets USP, are supplied for oral administration as 25 mg (yellow), 50 mg (green), 100 mg (beige), 200 mg (blue), 250 mg (purple) and 300 mg (gray) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, macrogol, magnesium stearate, methacrylic acid copolymer dispersion, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 25 mg tablets also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 50 mg tablets also contain FD&C Blue No. 2 and iron oxide yellow. The 100 mg tablets also contain iron oxide red and iron oxide yellow. The 200 mg tablets also contain FD&C Blue No. 2. The 250 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40. The 300 mg tablets also contain black iron oxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The core tablets are coated with an enteric coat and have pore forming ingredient in the coat to enable a controlled release of the drug in the acidic environment of the stomach. The combinations of the modified-release core and the enteric coat are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. USP Dissolution Test pending.</Description>
</NDC>
<NDC>
<NDCCode>42658-105-04</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42658-105-04) </PackageDescription>
<NDC11Code>42658-0105-04</NDC11Code>
<ProductNDC>42658-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206061</ApplicationNumber>
<LabelerName>Hisun Pharmaceuiticals USA, Inc</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>42658-105-08</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42658-105-08) </PackageDescription>
<NDC11Code>42658-0105-08</NDC11Code>
<ProductNDC>42658-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206061</ApplicationNumber>
<LabelerName>Hisun Pharmaceuiticals USA, Inc</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>42658-106-04</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42658-106-04) </PackageDescription>
<NDC11Code>42658-0106-04</NDC11Code>
<ProductNDC>42658-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206061</ApplicationNumber>
<LabelerName>Hisun Pharmaceuiticals USA, Inc</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Pravastatin sodium tablets USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S-[1α (β S*,δ S*),2α,6α,8β( R*),8aα]]-. Structural formula. C 23H 35NaO 7 MW 446.52. Pravastatin sodium is an odorless, white to yellowish-white powder or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients include: magnesium oxide, anhydrous dibasic calcium phosphate, lactose monohydrate, cellulose powder, yellow ferric oxide, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.</Description>
</NDC>
</NDCList>