{
"NDC": [
{
"NDCCode": "70518-0514-0",
"PackageDescription": "1 INHALER in 1 CARTON (70518-0514-0) > 60 POWDER in 1 INHALER",
"NDC11Code": "70518-0514-00",
"ProductNDC": "70518-0514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Advair",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20170510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021077",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "100; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170510",
"SamplePackage": "N"
},
{
"NDCCode": "15631-0514-0",
"PackageDescription": "1 TABLET in 1 BLISTER PACK (15631-0514-0)",
"NDC11Code": "15631-0514-00",
"ProductNDC": "15631-0514",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimonium Tartaricum",
"NonProprietaryName": "Antimonium Tartaricum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151218",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "50090-0514-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-0514-0) ",
"NDC11Code": "50090-0514-00",
"ProductNDC": "50090-0514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076900",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160629",
"SamplePackage": "N"
},
{
"NDCCode": "58118-0514-0",
"PackageDescription": "1 TABLET in 1 PACKAGE (58118-0514-0)",
"NDC11Code": "58118-0514-00",
"ProductNDC": "58118-0514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077321",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-06-27"
},
{
"NDCCode": "67345-0514-0",
"PackageDescription": "4.3 g in 1 CARTON (67345-0514-0)",
"NDC11Code": "67345-0514-00",
"ProductNDC": "67345-0514",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purminerals 4 In 1 Makeup Spf 15 Dark",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060717",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "PUR MINERALS",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".387",
"StrengthUnit": "g/4.3g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "17856-0514-5",
"PackageDescription": "5 mL in 1 CUP (17856-0514-5) ",
"NDC11Code": "17856-0514-05",
"ProductNDC": "17856-0514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyosyne",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "ELIXIR",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2025-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240412",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "HYOSYNE ORAL DROPS(Hyoscyamine Sulfate Oral Solution) contain 0.125 mg hyoscyamine sulfate per mL with 5% v/v alcohol for oral administration. HYOSYNE ELIXIR(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v alcohol for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. HYOSYNE ORAL DROPSalso contain as inactive ingredients: Alcohol, citric acid, FD&C red #40, FD&C yellow #6, flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. HYOSYNE ELIXIRalso contain as inactive ingredients: Alcohol, citric acid, FD&C red #40, FD&C yellow #6, flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose."
},
{
"NDCCode": "50742-514-30",
"PackageDescription": "30 POUCH in 1 BOX, UNIT-DOSE (50742-514-30) / 1 PATCH in 1 POUCH",
"NDC11Code": "50742-0514-30",
"ProductNDC": "50742-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-dur",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20171206",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020145",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2023-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171206",
"SamplePackage": "N",
"IndicationAndUsage": "Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. The NITRO-DUR ® (nitroglycerin) Transdermal Infusion System is a flat unit designed to provide continuous controlled release of nitroglycerin through intact skin. The rate of release of nitroglycerin is linearly dependent upon the area of the applied system; each cm 2 of applied system delivers approximately 0.02 mg of nitroglycerin per hour. Thus, the 5-,10-, 15-, 20-, 30-, and 40-cm2 systems deliver approximately 0.1, 0.2, 0.3, 0.4, 0.6, and 0.8 mg of nitroglycerin per hour, respectively. The remainder of the nitroglycerin in each system serves as a reservoir and is not delivered in normal use. After 12 hours, for example, each system has delivered approximately 6% of its original content of nitroglycerin. The NITRO-DUR transdermal system contains nitroglycerin in acrylic-based polymer adhesives with a resinous cross-linking agent to provide a continuous source of active ingredient. Each unit is sealed in a paper polyethylene-foil pouch. Cross section of the system."
},
{
"NDCCode": "51862-514-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (51862-514-01) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0514-01",
"ProductNDC": "51862-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desogestrel And Ethinyl Estradiol",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091234",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201004",
"SamplePackage": "N",
"IndicationAndUsage": "Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.",
"Description": "Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "51862-514-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-514-02) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0514-02",
"ProductNDC": "51862-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desogestrel And Ethinyl Estradiol",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091234",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201004",
"SamplePackage": "N",
"IndicationAndUsage": "Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.",
"Description": "Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "51862-514-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (51862-514-03) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0514-03",
"ProductNDC": "51862-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desogestrel And Ethinyl Estradiol",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091234",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201004",
"SamplePackage": "N",
"IndicationAndUsage": "Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.",
"Description": "Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "51862-514-06",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (51862-514-06) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0514-06",
"ProductNDC": "51862-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desogestrel And Ethinyl Estradiol",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091234",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201004",
"SamplePackage": "N",
"IndicationAndUsage": "Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.",
"Description": "Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "60923-514-23",
"PackageDescription": "1 KIT in 1 CARTON (60923-514-23) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 23 POUCH in 1 BOX / 1 SWAB in 1 POUCH",
"NDC11Code": "60923-0514-23",
"ProductNDC": "60923-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elevidys",
"NonProprietaryName": "Delandistrogene Moxeparvovec-rokl",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125781",
"LabelerName": "Sarepta Therapeutics, Inc.",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].",
"Description": "ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3."
},
{
"NDCCode": "62332-514-20",
"PackageDescription": "1 VIAL in 1 CARTON (62332-514-20) / 20 mL in 1 VIAL",
"NDC11Code": "62332-0514-20",
"ProductNDC": "62332-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Treprostinil",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20210211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211574",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210211",
"SamplePackage": "N",
"IndicationAndUsage": "Treprostinil injection is a prostacyclin mimetic indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1) Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Treprostinil injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Treprostinil injection is supplied in 20-mL multi-dose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2.Treprostinil is chemically stable at room temperature and neutral pH.Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1-Hbenz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is."
},
{
"NDCCode": "63187-514-05",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (63187-514-05) ",
"NDC11Code": "63187-0514-05",
"ProductNDC": "63187-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077652",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide."
},
{
"NDCCode": "63187-514-07",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (63187-514-07) ",
"NDC11Code": "63187-0514-07",
"ProductNDC": "63187-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077652",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide."
},
{
"NDCCode": "63187-514-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (63187-514-10) ",
"NDC11Code": "63187-0514-10",
"ProductNDC": "63187-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077652",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide."
},
{
"NDCCode": "63187-514-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (63187-514-15) ",
"NDC11Code": "63187-0514-15",
"ProductNDC": "63187-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077652",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide."
},
{
"NDCCode": "63187-514-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63187-514-30) ",
"NDC11Code": "63187-0514-30",
"ProductNDC": "63187-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077652",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide."
},
{
"NDCCode": "63187-514-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (63187-514-60) ",
"NDC11Code": "63187-0514-60",
"ProductNDC": "63187-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077652",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide."
},
{
"NDCCode": "63187-514-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63187-514-90) ",
"NDC11Code": "63187-0514-90",
"ProductNDC": "63187-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077652",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide."
},
{
"NDCCode": "64980-514-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE",
"NDC11Code": "64980-0514-01",
"ProductNDC": "64980-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20141215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077259",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141215",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of Timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of timolol maleate ophthalmic solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolarity is 274-328 mOsm/ Kg. Each mL of timolol maleate ophthalmic solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium chloride, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative."
},
{
"NDCCode": "64980-514-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE",
"NDC11Code": "64980-0514-05",
"ProductNDC": "64980-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20141215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077259",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141215",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of Timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of timolol maleate ophthalmic solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolarity is 274-328 mOsm/ Kg. Each mL of timolol maleate ophthalmic solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium chloride, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative."
},
{
"NDCCode": "64980-514-15",
"PackageDescription": "1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE",
"NDC11Code": "64980-0514-15",
"ProductNDC": "64980-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20141215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077259",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141215",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of Timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of timolol maleate ophthalmic solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolarity is 274-328 mOsm/ Kg. Each mL of timolol maleate ophthalmic solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium chloride, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative."
},
{
"NDCCode": "67184-0514-1",
"PackageDescription": "1 VIAL in 1 CARTON (67184-0514-1) > 5 mL in 1 VIAL",
"NDC11Code": "67184-0514-01",
"ProductNDC": "67184-0514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Palonosetron",
"NonProprietaryName": "Palonosetron Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205648",
"LabelerName": "Qilu Pharmaceutical Co., Ltd.",
"SubstanceName": "PALONOSETRON HYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180919",
"SamplePackage": "N",
"IndicationAndUsage": "Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in. Adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). (1), 2 acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1), 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1).",
"Description": "Palonosetron Hydrochloride Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as a 5 mL or 1.5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron HCl), 207.5 mg mannitol and citrate buffer in water for intravenous administration. Each 1.5 mL vial contains: 0.075 mg palonosetron (equivalent to 0.084 mg palonosetron HCl), 62.25 mg mannitol and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL and 1.5 mL vials is 4.5 to 5.5."
},
{
"NDCCode": "68682-514-92",
"PackageDescription": "1 TUBE in 1 CARTON (68682-514-92) / 20 g in 1 TUBE",
"NDC11Code": "68682-0514-92",
"ProductNDC": "68682-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020475",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130314",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin Gel Microsphere is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. Tretinoin Gel Microsphere (tretinoin) gel is for topical use. Each gram of Tretinoin Gel Microsphere gel: : 1 0.04%, contains 0.4 mg of tretinoin , 2 0.08%, contains 0.8 mg of tretinoin , 3 0.1%, contains 1 mg of tretinoin ."
},
{
"NDCCode": "68682-514-94",
"PackageDescription": "1 TUBE in 1 CARTON (68682-514-94) / 45 g in 1 TUBE",
"NDC11Code": "68682-0514-94",
"ProductNDC": "68682-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020475",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130314",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin Gel Microsphere is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. Tretinoin Gel Microsphere (tretinoin) gel is for topical use. Each gram of Tretinoin Gel Microsphere gel: : 1 0.04%, contains 0.4 mg of tretinoin , 2 0.08%, contains 0.8 mg of tretinoin , 3 0.1%, contains 1 mg of tretinoin ."
},
{
"NDCCode": "68682-514-95",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (68682-514-95) / 50 g in 1 BOTTLE, PUMP",
"NDC11Code": "68682-0514-95",
"ProductNDC": "68682-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020475",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130314",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin Gel Microsphere is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. Tretinoin Gel Microsphere (tretinoin) gel is for topical use. Each gram of Tretinoin Gel Microsphere gel: : 1 0.04%, contains 0.4 mg of tretinoin , 2 0.08%, contains 0.8 mg of tretinoin , 3 0.1%, contains 1 mg of tretinoin ."
},
{
"NDCCode": "69292-514-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (69292-514-01) ",
"NDC11Code": "69292-0514-01",
"ProductNDC": "69292-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefpodoxime Proxetil",
"NonProprietaryName": "Cefpodoxime Proxetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210568",
"LabelerName": "Amici Pharmaceuticals, LLC.",
"SubstanceName": "CEFPODOXIME PROXETIL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2023-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221221",
"SamplePackage": "N",
"IndicationAndUsage": "Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations.Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilusinfluenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains). Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes.NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available.Community-acquired pneumonia caused by S. pneumoniae or H. Influenzae (including beta-lactamase-producing strains).Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis. Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains of H. influenzae.Acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).Acute, uncomplicated ano-rectal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeae has not been established. Data do not support the use of cefpodoxime proxetil in the treatment of pharyngeal infections due to N. gonorrhoeae in men or women.Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.NOTE: In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related. The effective therapeutic dose for skin infections was higher than those used in other recommended indications. (See DOSAGE AND ADMINISTRATION.)Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.NOTE: In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetil's lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. (See CLINICAL STUDIES section.)Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefpodoxime proxetil tablets, and other antibacterial drugs, cefpodoxime proxetil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R, 7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z) methoxyimino} acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate. Its molecular formula is C21H27N5O9S2 and its structural formula is represented below:The molecular weight of cefpodoxime proxetil is 557.6. Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as film-coated tablets. Cefpodoxime proxetil tablets, USP contain cefpodoxime proxetil USP equivalent to 100 mg or 200 mg of cefpodoxime activity. Each film-coated tablet contains the following inactive ingredients: Carboxymethyl cellulose calcium, colloidal silicon dioxide, crospovidone, FD&C Yellow No. 6, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, macrogol, magnesium stearate, sodium lauryl sulfate and titanium dioxide."
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"Description": "Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R, 7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z) methoxyimino} acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate. Its molecular formula is C21H27N5O9S2 and its structural formula is represented below:The molecular weight of cefpodoxime proxetil is 557.6. Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as film-coated tablets. Cefpodoxime proxetil tablets, USP contain cefpodoxime proxetil USP equivalent to 100 mg or 200 mg of cefpodoxime activity. Each film-coated tablet contains the following inactive ingredients: Carboxymethyl cellulose calcium, colloidal silicon dioxide, crospovidone, FD&C Yellow No. 6, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, macrogol, magnesium stearate, sodium lauryl sulfate and titanium dioxide."
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"ProprietaryName": "Vancomycin Hydrochloride",
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"LabelerName": "Advanced Rx of Tennessee, LLC",
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"IndicationAndUsage": "Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections., 2 Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.",
"Description": "Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients. Vancomycin hydrochloride has the structural formula."
}
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<IndicationAndUsage>Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.</IndicationAndUsage>
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<IndicationAndUsage>Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each "active" orange tablet with "S3" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each "inactive" reminder white, biconvex, round tablets with "P" debossed on one side and "N" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51862-514-02</NDCCode>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each "active" orange tablet with "S3" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each "inactive" reminder white, biconvex, round tablets with "P" debossed on one side and "N" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51862-514-03</NDCCode>
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<IndicationAndUsage>Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each "active" orange tablet with "S3" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each "inactive" reminder white, biconvex, round tablets with "P" debossed on one side and "N" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51862-514-06</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (51862-514-06) > 1 KIT in 1 BLISTER PACK</PackageDescription>
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<LabelerName>Mayne Pharma Inc.</LabelerName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each "active" orange tablet with "S3" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each "inactive" reminder white, biconvex, round tablets with "P" debossed on one side and "N" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>60923-514-23</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (60923-514-23) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 23 POUCH in 1 BOX / 1 SWAB in 1 POUCH</PackageDescription>
<NDC11Code>60923-0514-23</NDC11Code>
<ProductNDC>60923-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elevidys</ProprietaryName>
<NonProprietaryName>Delandistrogene Moxeparvovec-rokl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125781</ApplicationNumber>
<LabelerName>Sarepta Therapeutics, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
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<IndicationAndUsage>ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].</IndicationAndUsage>
<Description>ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3.</Description>
</NDC>
<NDC>
<NDCCode>62332-514-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (62332-514-20) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>62332-0514-20</NDC11Code>
<ProductNDC>62332-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Treprostinil</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20210211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211574</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<StartMarketingDatePackage>20210211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treprostinil injection is a prostacyclin mimetic indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1) Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Treprostinil injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Treprostinil injection is supplied in 20-mL multi-dose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2.Treprostinil is chemically stable at room temperature and neutral pH.Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1-Hbenz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is.</Description>
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<NDC>
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<PackageDescription>5 TABLET, FILM COATED in 1 BOTTLE (63187-514-05) </PackageDescription>
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<ProductNDC>63187-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077652</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-514-07</NDCCode>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide.</Description>
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<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (63187-514-10) </PackageDescription>
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<ProductNDC>63187-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<LabelerName>Proficient Rx LP</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide.</Description>
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<ProductNDC>63187-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide.</Description>
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<NDCCode>63187-514-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63187-514-30) </PackageDescription>
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<ProductNDC>63187-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide.</Description>
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<NDCCode>63187-514-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (63187-514-60) </PackageDescription>
<NDC11Code>63187-0514-60</NDC11Code>
<ProductNDC>63187-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
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<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide.</Description>
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<NDC>
<NDCCode>63187-514-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63187-514-90) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacinare a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13)., 9 Plague (1.14).</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. Its molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3> Cu+2> Zn+2> Mg+2> Ca+2. Excipients and Description of Dosage Forms. Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide.</Description>
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<NDC>
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<PackageDescription>1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>64980-0514-01</NDC11Code>
<ProductNDC>64980-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20141215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077259</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of Timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of timolol maleate ophthalmic solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolarity is 274-328 mOsm/ Kg. Each mL of timolol maleate ophthalmic solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium chloride, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative.</Description>
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<PackageDescription>1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE</PackageDescription>
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<ProductNDC>64980-514</ProductNDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077259</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of Timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of timolol maleate ophthalmic solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolarity is 274-328 mOsm/ Kg. Each mL of timolol maleate ophthalmic solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium chloride, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative.</Description>
</NDC>
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<NDCCode>64980-514-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>64980-0514-15</NDC11Code>
<ProductNDC>64980-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20141215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077259</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of Timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of timolol maleate ophthalmic solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolarity is 274-328 mOsm/ Kg. Each mL of timolol maleate ophthalmic solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium chloride, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative.</Description>
</NDC>
<NDC>
<NDCCode>67184-0514-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (67184-0514-1) > 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>67184-0514-01</NDC11Code>
<ProductNDC>67184-0514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Palonosetron</ProprietaryName>
<NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205648</ApplicationNumber>
<LabelerName>Qilu Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in. Adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). (1), 2 acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1), 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1).</IndicationAndUsage>
<Description>Palonosetron Hydrochloride Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as a 5 mL or 1.5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron HCl), 207.5 mg mannitol and citrate buffer in water for intravenous administration. Each 1.5 mL vial contains: 0.075 mg palonosetron (equivalent to 0.084 mg palonosetron HCl), 62.25 mg mannitol and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL and 1.5 mL vials is 4.5 to 5.5.</Description>
</NDC>
<NDC>
<NDCCode>68682-514-92</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68682-514-92) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>68682-0514-92</NDC11Code>
<ProductNDC>68682-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020475</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin Gel Microsphere is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. Tretinoin Gel Microsphere (tretinoin) gel is for topical use. Each gram of Tretinoin Gel Microsphere gel: : 1 0.04%, contains 0.4 mg of tretinoin , 2 0.08%, contains 0.8 mg of tretinoin , 3 0.1%, contains 1 mg of tretinoin .</Description>
</NDC>
<NDC>
<NDCCode>68682-514-94</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68682-514-94) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>68682-0514-94</NDC11Code>
<ProductNDC>68682-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020475</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin Gel Microsphere is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. Tretinoin Gel Microsphere (tretinoin) gel is for topical use. Each gram of Tretinoin Gel Microsphere gel: : 1 0.04%, contains 0.4 mg of tretinoin , 2 0.08%, contains 0.8 mg of tretinoin , 3 0.1%, contains 1 mg of tretinoin .</Description>
</NDC>
<NDC>
<NDCCode>68682-514-95</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (68682-514-95) / 50 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>68682-0514-95</NDC11Code>
<ProductNDC>68682-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020475</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin Gel Microsphere is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. Tretinoin Gel Microsphere (tretinoin) gel is for topical use. Each gram of Tretinoin Gel Microsphere gel: : 1 0.04%, contains 0.4 mg of tretinoin , 2 0.08%, contains 0.8 mg of tretinoin , 3 0.1%, contains 1 mg of tretinoin .</Description>
</NDC>
<NDC>
<NDCCode>69292-514-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (69292-514-01) </PackageDescription>
<NDC11Code>69292-0514-01</NDC11Code>
<ProductNDC>69292-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefpodoxime Proxetil</ProprietaryName>
<NonProprietaryName>Cefpodoxime Proxetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210568</ApplicationNumber>
<LabelerName>Amici Pharmaceuticals, LLC.</LabelerName>
<SubstanceName>CEFPODOXIME PROXETIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations.Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilusinfluenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains). Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes.NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available.Community-acquired pneumonia caused by S. pneumoniae or H. Influenzae (including beta-lactamase-producing strains).Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis. Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains of H. influenzae.Acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).Acute, uncomplicated ano-rectal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeae has not been established. Data do not support the use of cefpodoxime proxetil in the treatment of pharyngeal infections due to N. gonorrhoeae in men or women.Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.NOTE: In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related. The effective therapeutic dose for skin infections was higher than those used in other recommended indications. (See DOSAGE AND ADMINISTRATION.)Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.NOTE: In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetil's lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. (See CLINICAL STUDIES section.)Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefpodoxime proxetil tablets, and other antibacterial drugs, cefpodoxime proxetil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R, 7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z) methoxyimino} acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate. Its molecular formula is C21H27N5O9S2 and its structural formula is represented below:The molecular weight of cefpodoxime proxetil is 557.6. Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as film-coated tablets. Cefpodoxime proxetil tablets, USP contain cefpodoxime proxetil USP equivalent to 100 mg or 200 mg of cefpodoxime activity. Each film-coated tablet contains the following inactive ingredients: Carboxymethyl cellulose calcium, colloidal silicon dioxide, crospovidone, FD&C Yellow No. 6, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, macrogol, magnesium stearate, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69292-514-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (69292-514-50) </PackageDescription>
<NDC11Code>69292-0514-50</NDC11Code>
<ProductNDC>69292-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefpodoxime Proxetil</ProprietaryName>
<NonProprietaryName>Cefpodoxime Proxetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210568</ApplicationNumber>
<LabelerName>Amici Pharmaceuticals, LLC.</LabelerName>
<SubstanceName>CEFPODOXIME PROXETIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations.Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilusinfluenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains). Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes.NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available.Community-acquired pneumonia caused by S. pneumoniae or H. Influenzae (including beta-lactamase-producing strains).Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis. Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains of H. influenzae.Acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).Acute, uncomplicated ano-rectal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeae has not been established. Data do not support the use of cefpodoxime proxetil in the treatment of pharyngeal infections due to N. gonorrhoeae in men or women.Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.NOTE: In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related. The effective therapeutic dose for skin infections was higher than those used in other recommended indications. (See DOSAGE AND ADMINISTRATION.)Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.NOTE: In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetil's lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. (See CLINICAL STUDIES section.)Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefpodoxime proxetil tablets, and other antibacterial drugs, cefpodoxime proxetil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R, 7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z) methoxyimino} acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate. Its molecular formula is C21H27N5O9S2 and its structural formula is represented below:The molecular weight of cefpodoxime proxetil is 557.6. Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as film-coated tablets. Cefpodoxime proxetil tablets, USP contain cefpodoxime proxetil USP equivalent to 100 mg or 200 mg of cefpodoxime activity. Each film-coated tablet contains the following inactive ingredients: Carboxymethyl cellulose calcium, colloidal silicon dioxide, crospovidone, FD&C Yellow No. 6, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, macrogol, magnesium stearate, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>80425-0514-1</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (80425-0514-1) </PackageDescription>
<NDC11Code>80425-0514-01</NDC11Code>
<ProductNDC>80425-0514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250418</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050606</ApplicationNumber>
<LabelerName>Advanced Rx of Tennessee, LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections., 2 Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients. Vancomycin hydrochloride has the structural formula.</Description>
</NDC>
</NDCList>