{
"NDC": [
{
"NDCCode": "55910-628-35",
"PackageDescription": "946 mL in 1 BOTTLE, PLASTIC (55910-628-35) ",
"NDC11Code": "55910-0628-35",
"ProductNDC": "55910-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160217",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "DOLGENCORP,LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160217",
"SamplePackage": "N"
},
{
"NDCCode": "55910-628-45",
"PackageDescription": "946 mL in 1 BOTTLE, PLASTIC (55910-628-45) ",
"NDC11Code": "55910-0628-45",
"ProductNDC": "55910-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160217",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Old East Main Co.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160217",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "55910-628-81",
"PackageDescription": "332 mL in 1 BOTTLE, PUMP (55910-628-81) ",
"NDC11Code": "55910-0628-81",
"ProductNDC": "55910-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160217",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "DOLGENCORP,LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160217",
"SamplePackage": "N"
},
{
"NDCCode": "55910-628-96",
"PackageDescription": "221 mL in 1 BOTTLE, PLASTIC (55910-628-96) ",
"NDC11Code": "55910-0628-96",
"ProductNDC": "55910-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160217",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Old East Main Co.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200206",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "21695-628-35",
"PackageDescription": "3.5 g in 1 TUBE (21695-628-35)",
"NDC11Code": "21695-0628-35",
"ProductNDC": "21695-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobradex",
"NonProprietaryName": "Tobramycin And Dexamethasone",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19880928",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050616",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "TOBRAMYCIN; DEXAMETHASONE",
"StrengthNumber": "3; 1",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens. Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.",
"Description": "TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below. Each gram of TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) contains: Actives: tobramycin 0.3% (3mg) and dexamethasone 0.1% (1mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil and white petrolatum."
},
{
"NDCCode": "43744-628-35",
"PackageDescription": "100 g in 1 DRUM (43744-628-35)",
"NDC11Code": "43744-0628-35",
"ProductNDC": "43744-628",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Monobenzone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20121001",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "MONOBENZONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "70645-628-35",
"PackageDescription": "15 PATCH in 1 BOX (70645-628-35) ",
"NDC11Code": "70645-0628-35",
"ProductNDC": "70645-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gen7t Plus",
"NonProprietaryName": "Lidocaine, Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190901",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "7T Pharma LLC",
"SubstanceName": "LIDOCAINE; MENTHOL",
"StrengthNumber": "490; 980",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"Description": "Gen7T Plus Patch® is a prescription topical patch containing 15 articulated patches or 10 articulated patches. Lidocaine is present in a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C14H22N2O. The molecular weight of lidocaine is 234.34 g/mol. Lidocaine has an octanol: water partition ration of 43 at pH 7.4, and has the following structure:. ** Lidocaine **. Menthol is present in a 7% concentration (w/w). The chemical name is (1R,2S,5R)‐2‐isopropyl-5-methylcyclohexanol. The empirical formula for Menthol is C10H20O with a molecular weight of 156.27 g/mol. Menthol contains colorless, hexangonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31OC to 36OC and has the following structure:. ** Menthol **. Gen7T Plus Patch® uses an adhesive hydrogel technology containing lidocaine 3.5% and menthol 7%, applied to a flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin."
},
{
"NDCCode": "75936-628-02",
"PackageDescription": "1 TUBE in 1 BOX (75936-628-02) / 35 mL in 1 TUBE (75936-628-01) ",
"NDC11Code": "75936-0628-02",
"ProductNDC": "75936-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Protectint 26w",
"NonProprietaryName": "Homosalate, Octisalate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231122",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Supergoop, LLC",
"SubstanceName": "HOMOSALATE; ZINC OXIDE; OCTISALATE",
"StrengthNumber": "7; 13.58; 5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231122",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "55910-153-35",
"PackageDescription": "700 mL in 1 BOTTLE, PLASTIC (55910-153-35) ",
"NDC11Code": "55910-0153-35",
"ProductNDC": "55910-153",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply Clean Dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "19950215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Old East Main Co.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19950215",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "55910-311-35",
"PackageDescription": "700 mL in 1 BOTTLE, PLASTIC (55910-311-35) ",
"NDC11Code": "55910-0311-35",
"ProductNDC": "55910-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "2 In 1 Dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050623",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "OLD EAST MAIN CO.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20050623",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "55910-352-12",
"PackageDescription": "1 TUBE in 1 CARTON (55910-352-12) / 35 g in 1 TUBE",
"NDC11Code": "55910-0352-12",
"ProductNDC": "55910-352",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dgh Greaseless Muscle Rub",
"ProprietaryNameSuffix": "Analgesic",
"NonProprietaryName": "Menthol, Unspecified Form And Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231219",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "DOLLAR GENERAL",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE",
"StrengthNumber": ".1; .15",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231219",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains in muscles and joints."
},
{
"NDCCode": "55910-405-35",
"PackageDescription": "35 g in 1 TUBE (55910-405-35)",
"NDC11Code": "55910-0405-35",
"ProductNDC": "55910-405",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cool Heat",
"NonProprietaryName": "Menthol And Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Dolgencorp Inc",
"SubstanceName": "MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "10; 30",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Uses. temporarily relieves minor pain associated with: 1 arthritis, 2 simple backache, 3 muscle strains, 4 sprains, 5 bruises, 6 cramps."
},
{
"NDCCode": "55910-568-33",
"PackageDescription": "1 TUBE in 1 CARTON (55910-568-33) > 9.35 g in 1 TUBE",
"NDC11Code": "55910-0568-33",
"ProductNDC": "55910-568",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dollar General Health Oral Pain Reliever",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150508",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Dolgencorp LLC",
"SubstanceName": "BENZOCAINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2021-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161004",
"SamplePackage": "N"
},
{
"NDCCode": "55910-898-35",
"PackageDescription": "700 mL in 1 BOTTLE, PLASTIC (55910-898-35) ",
"NDC11Code": "55910-0898-35",
"ProductNDC": "55910-898",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "19981208",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "OLD EAST MAIN CO",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19981208",
"SamplePackage": "N",
"IndicationAndUsage": "help prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "55910-942-35",
"PackageDescription": "700 mL in 1 BOTTLE, PLASTIC (55910-942-35) ",
"NDC11Code": "55910-0942-35",
"ProductNDC": "55910-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "2 In 1 Dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "DOLGENCORP, LLC",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160118",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "55910-988-35",
"PackageDescription": "29 mL in 1 BOTTLE, SPRAY (55910-988-35)",
"NDC11Code": "55910-0988-35",
"ProductNDC": "55910-988",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Bacterial Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Dolgencorp Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use."
},
{
"NDCCode": "57664-628-88",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-628-88) ",
"NDC11Code": "57664-0628-88",
"ProductNDC": "57664-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206734",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211105",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [ see Clinical Studies ( 14)].",
"Description": "Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d- threoenantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer (Type B), black iron oxide, D&C Red No. 28 (15 mg, and 40 mg strengths), FD&C Blue No. 1 (15 mg, and 40 mg strengths), FD&C Blue No. 2 (5 mg, 25 mg, and 35 mg strengths), gelatin, hypromellose, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol, propylene glycol, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10 mg, 15 mg, 30 mg, 35 mg, and 40 mg strengths)."
},
{
"NDCCode": "76282-628-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (76282-628-05) ",
"NDC11Code": "76282-0628-05",
"ProductNDC": "76282-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077534",
"LabelerName": "Exelan Pharmaceuticals Inc.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171110",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3- dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available only in tablet dosage form. Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content. The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets."
},
{
"NDCCode": "76282-628-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (76282-628-10) ",
"NDC11Code": "76282-0628-10",
"ProductNDC": "76282-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077534",
"LabelerName": "Exelan Pharmaceuticals Inc.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171110",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3- dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available only in tablet dosage form. Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content. The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets."
},
{
"NDCCode": "76282-628-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (76282-628-30) ",
"NDC11Code": "76282-0628-30",
"ProductNDC": "76282-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077534",
"LabelerName": "Exelan Pharmaceuticals Inc.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171110",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3- dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available only in tablet dosage form. Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content. The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets."
},
{
"NDCCode": "76282-628-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (76282-628-90) ",
"NDC11Code": "76282-0628-90",
"ProductNDC": "76282-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077534",
"LabelerName": "Exelan Pharmaceuticals Inc.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171110",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3- dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available only in tablet dosage form. Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content. The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets."
},
{
"NDCCode": "0074-0522-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60) ",
"NDC11Code": "00074-0522-60",
"ProductNDC": "0074-0522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kaletra",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100618",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021906",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "100; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100618",
"SamplePackage": "N",
"IndicationAndUsage": "KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .",
"Description": "KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Yellow or red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pale yellow or pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir."
},
{
"NDCCode": "0074-3008-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0074-3008-60) ",
"NDC11Code": "00074-3008-60",
"ProductNDC": "0074-3008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kaletra",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021906",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "100; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240614",
"SamplePackage": "N",
"IndicationAndUsage": "KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .",
"Description": "KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir."
},
{
"NDCCode": "0074-3956-46",
"PackageDescription": "1 BOTTLE in 1 CARTON (0074-3956-46) / 160 mL in 1 BOTTLE",
"NDC11Code": "00074-3956-46",
"ProductNDC": "0074-3956",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kaletra",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100618",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021251",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "80; 20",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100618",
"SamplePackage": "N",
"IndicationAndUsage": "KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .",
"Description": "KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir."
},
{
"NDCCode": "0074-4014-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (0074-4014-12) ",
"NDC11Code": "00074-4014-12",
"ProductNDC": "0074-4014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kaletra",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021906",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "200; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240215",
"SamplePackage": "N",
"IndicationAndUsage": "KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .",
"Description": "KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir."
},
{
"NDCCode": "0074-6799-22",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (0074-6799-22) ",
"NDC11Code": "00074-6799-22",
"ProductNDC": "0074-6799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kaletra",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100618",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021906",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "200; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100618",
"SamplePackage": "N",
"IndicationAndUsage": "KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .",
"Description": "KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Yellow or red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pale yellow or pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir."
},
{
"NDCCode": "0527-1947-48",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0527-1947-48) > 160 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00527-1947-48",
"ProductNDC": "0527-1947",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopinavir-ritonavir",
"NonProprietaryName": "Lopinavir-ritonavir",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20161227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207407",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "80; 20",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20161227",
"SamplePackage": "N",
"IndicationAndUsage": "Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see Microbiology (12.4)]. .",
"Description": "Lopinavir and Ritonavir Oral Solution USP is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula. Lopinavir and ritonavir oral solution is available for oral administration as 80 mg lopinavir and 20 mg ritonavir per milliliter with the following inactive ingredients: bubble gum flavor, ethanol, glycerin, high fructose corn syrup, malic acid, polyoxyl 40 hydrogenated castor oil, povidone, propylene glycol, sodium hydroxide, sucralose, and water. Lopinavir and ritonavir oral solution contains approximately 42% (v/v) ethanol and approximately 15% (w/v) propylene glycol."
},
{
"NDCCode": "0591-2927-54",
"PackageDescription": "1 INHALER in 1 CARTON (0591-2927-54) / 200 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "00591-2927-54",
"ProductNDC": "0591-2927",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol Tartrate Hfa Inhalation",
"NonProprietaryName": "Levalbuterol Tartrate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "ORAL",
"StartMarketingDate": "20161003",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021730",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LEVALBUTEROL TARTRATE",
"StrengthNumber": "45",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161003",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol tartrate HFA inhalation aerosol is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1).",
"Description": "The active component of Levalbuterol tartrate HFA inhalation aerosol is levalbuterol tartrate, the (R)-enantiomer of albuterol. Levalbuterol tartrate is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. Levalbuterol tartrate has the chemical name (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol L-tartrate (2:1 salt), and it has the following chemical structure. The molecular weight of levalbuterol tartrate is 628.71, and its empirical formula is (C13H21NO3)2 · C4H6O6. It is a white to light-yellow solid, freely soluble in water and very slightly soluble in ethanol. Levalbuterol tartrate is the generic name for (R)-albuterol tartrate in the United States. Levalbuterol tartrate HFA inhalation aerosol is a pressurized metered-dose aerosol inhaler (MDI) fitted with a dose indicator, which produces an aerosol for oral inhalation. It contains a suspension of micronized levalbuterol tartrate, propellant HFA-134a (1,1,1,2-tetrafluoroethane), Dehydrated Alcohol USP, and Oleic Acid NF. After priming with 4 actuations, each actuation of the inhaler delivers 67.8 mcg of levalbuterol tartrate (equivalent to 51.6 mcg of levalbuterol free base) from the valve and 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator mouthpiece. Each 15 g canister provides 200 actuations (or inhalations)."
},
{
"NDCCode": "10135-628-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (10135-628-01)",
"NDC11Code": "10135-0628-01",
"ProductNDC": "10135-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207118",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "ACETAMINOPHEN; CAFFEINE; BUTALBITAL",
"StrengthNumber": "300; 40; 50",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Barbiturates [CS],Barbiturate [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen, and caffeine capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients: Butalbital, USP……………………50 mg Acetaminophen, USP…………….300 mg Caffeine, USP……………………..40 mg. Inactive Ingredients: FD&C blue # 1, FD&C red # 40, gelatin, microcrystalline cellulose, stearic acid, talc, titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula."
},
{
"NDCCode": "10237-628-60",
"PackageDescription": "1 TUBE in 1 CARTON (10237-628-60) > 170 g in 1 TUBE",
"NDC11Code": "10237-0628-60",
"ProductNDC": "10237-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aim Tartar Control",
"ProprietaryNameSuffix": "Plus Mouthwash And Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20040301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
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<NDC>
<NDCCode>55910-628-35</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (55910-628-35) </PackageDescription>
<NDC11Code>55910-0628-35</NDC11Code>
<ProductNDC>55910-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>DOLGENCORP,LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55910-628-45</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (55910-628-45) </PackageDescription>
<NDC11Code>55910-0628-45</NDC11Code>
<ProductNDC>55910-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Old East Main Co.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-628-81</NDCCode>
<PackageDescription>332 mL in 1 BOTTLE, PUMP (55910-628-81) </PackageDescription>
<NDC11Code>55910-0628-81</NDC11Code>
<ProductNDC>55910-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>DOLGENCORP,LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55910-628-96</NDCCode>
<PackageDescription>221 mL in 1 BOTTLE, PLASTIC (55910-628-96) </PackageDescription>
<NDC11Code>55910-0628-96</NDC11Code>
<ProductNDC>55910-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Old East Main Co.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-628-35</NDCCode>
<PackageDescription>3.5 g in 1 TUBE (21695-628-35)</PackageDescription>
<NDC11Code>21695-0628-35</NDC11Code>
<ProductNDC>21695-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobradex</ProprietaryName>
<NonProprietaryName>Tobramycin And Dexamethasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19880928</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050616</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>TOBRAMYCIN; DEXAMETHASONE</SubstanceName>
<StrengthNumber>3; 1</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens. Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.</IndicationAndUsage>
<Description>TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below. Each gram of TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) contains: Actives: tobramycin 0.3% (3mg) and dexamethasone 0.1% (1mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>43744-628-35</NDCCode>
<PackageDescription>100 g in 1 DRUM (43744-628-35)</PackageDescription>
<NDC11Code>43744-0628-35</NDC11Code>
<ProductNDC>43744-628</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Monobenzone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20121001</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>MONOBENZONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70645-628-35</NDCCode>
<PackageDescription>15 PATCH in 1 BOX (70645-628-35) </PackageDescription>
<NDC11Code>70645-0628-35</NDC11Code>
<ProductNDC>70645-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gen7t Plus</ProprietaryName>
<NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>7T Pharma LLC</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL</SubstanceName>
<StrengthNumber>490; 980</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Gen7T Plus Patch® is a prescription topical patch containing 15 articulated patches or 10 articulated patches. Lidocaine is present in a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C14H22N2O. The molecular weight of lidocaine is 234.34 g/mol. Lidocaine has an octanol: water partition ration of 43 at pH 7.4, and has the following structure:. ** Lidocaine **. Menthol is present in a 7% concentration (w/w). The chemical name is (1R,2S,5R)‐2‐isopropyl-5-methylcyclohexanol. The empirical formula for Menthol is C10H20O with a molecular weight of 156.27 g/mol. Menthol contains colorless, hexangonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31OC to 36OC and has the following structure:. ** Menthol **. Gen7T Plus Patch® uses an adhesive hydrogel technology containing lidocaine 3.5% and menthol 7%, applied to a flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin.</Description>
</NDC>
<NDC>
<NDCCode>75936-628-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (75936-628-02) / 35 mL in 1 TUBE (75936-628-01) </PackageDescription>
<NDC11Code>75936-0628-02</NDC11Code>
<ProductNDC>75936-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Protectint 26w</ProprietaryName>
<NonProprietaryName>Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Supergoop, LLC</LabelerName>
<SubstanceName>HOMOSALATE; ZINC OXIDE; OCTISALATE</SubstanceName>
<StrengthNumber>7; 13.58; 5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-153-35</NDCCode>
<PackageDescription>700 mL in 1 BOTTLE, PLASTIC (55910-153-35) </PackageDescription>
<NDC11Code>55910-0153-35</NDC11Code>
<ProductNDC>55910-153</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply Clean Dandruff</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19950215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Old East Main Co.</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-311-35</NDCCode>
<PackageDescription>700 mL in 1 BOTTLE, PLASTIC (55910-311-35) </PackageDescription>
<NDC11Code>55910-0311-35</NDC11Code>
<ProductNDC>55910-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>2 In 1 Dandruff</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050623</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>OLD EAST MAIN CO.</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-352-12</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (55910-352-12) / 35 g in 1 TUBE</PackageDescription>
<NDC11Code>55910-0352-12</NDC11Code>
<ProductNDC>55910-352</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dgh Greaseless Muscle Rub</ProprietaryName>
<ProprietaryNameSuffix>Analgesic</ProprietaryNameSuffix>
<NonProprietaryName>Menthol, Unspecified Form And Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>DOLLAR GENERAL</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>.1; .15</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains in muscles and joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-405-35</NDCCode>
<PackageDescription>35 g in 1 TUBE (55910-405-35)</PackageDescription>
<NDC11Code>55910-0405-35</NDC11Code>
<ProductNDC>55910-405</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cool Heat</ProprietaryName>
<NonProprietaryName>Menthol And Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Dolgencorp Inc</LabelerName>
<SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10; 30</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses. temporarily relieves minor pain associated with: 1 arthritis, 2 simple backache, 3 muscle strains, 4 sprains, 5 bruises, 6 cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-568-33</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (55910-568-33) > 9.35 g in 1 TUBE</PackageDescription>
<NDC11Code>55910-0568-33</NDC11Code>
<ProductNDC>55910-568</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dollar General Health Oral Pain Reliever</ProprietaryName>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Dolgencorp LLC</LabelerName>
<SubstanceName>BENZOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55910-898-35</NDCCode>
<PackageDescription>700 mL in 1 BOTTLE, PLASTIC (55910-898-35) </PackageDescription>
<NDC11Code>55910-0898-35</NDC11Code>
<ProductNDC>55910-898</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dry Scalp Care</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19981208</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>OLD EAST MAIN CO</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>help prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-942-35</NDCCode>
<PackageDescription>700 mL in 1 BOTTLE, PLASTIC (55910-942-35) </PackageDescription>
<NDC11Code>55910-0942-35</NDC11Code>
<ProductNDC>55910-942</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>2 In 1 Dandruff</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>DOLGENCORP, LLC</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-988-35</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE, SPRAY (55910-988-35)</PackageDescription>
<NDC11Code>55910-0988-35</NDC11Code>
<ProductNDC>55910-988</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Bacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Dolgencorp Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57664-628-88</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-628-88) </PackageDescription>
<NDC11Code>57664-0628-88</NDC11Code>
<ProductNDC>57664-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206734</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [ see Clinical Studies ( 14)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d- threoenantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer (Type B), black iron oxide, D&C Red No. 28 (15 mg, and 40 mg strengths), FD&C Blue No. 1 (15 mg, and 40 mg strengths), FD&C Blue No. 2 (5 mg, 25 mg, and 35 mg strengths), gelatin, hypromellose, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol, propylene glycol, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10 mg, 15 mg, 30 mg, 35 mg, and 40 mg strengths).</Description>
</NDC>
<NDC>
<NDCCode>76282-628-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (76282-628-05) </PackageDescription>
<NDC11Code>76282-0628-05</NDC11Code>
<ProductNDC>76282-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077534</ApplicationNumber>
<LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3- dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available only in tablet dosage form. Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content. The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>76282-628-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (76282-628-10) </PackageDescription>
<NDC11Code>76282-0628-10</NDC11Code>
<ProductNDC>76282-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077534</ApplicationNumber>
<LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3- dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available only in tablet dosage form. Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content. The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>76282-628-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (76282-628-30) </PackageDescription>
<NDC11Code>76282-0628-30</NDC11Code>
<ProductNDC>76282-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077534</ApplicationNumber>
<LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3- dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available only in tablet dosage form. Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content. The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>76282-628-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (76282-628-90) </PackageDescription>
<NDC11Code>76282-0628-90</NDC11Code>
<ProductNDC>76282-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077534</ApplicationNumber>
<LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3- dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available only in tablet dosage form. Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content. The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>0074-0522-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60) </PackageDescription>
<NDC11Code>00074-0522-60</NDC11Code>
<ProductNDC>0074-0522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kaletra</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100618</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021906</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .</IndicationAndUsage>
<Description>KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Yellow or red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pale yellow or pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir.</Description>
</NDC>
<NDC>
<NDCCode>0074-3008-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0074-3008-60) </PackageDescription>
<NDC11Code>00074-3008-60</NDC11Code>
<ProductNDC>0074-3008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kaletra</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021906</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .</IndicationAndUsage>
<Description>KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir.</Description>
</NDC>
<NDC>
<NDCCode>0074-3956-46</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0074-3956-46) / 160 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00074-3956-46</NDC11Code>
<ProductNDC>0074-3956</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kaletra</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100618</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021251</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>80; 20</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .</IndicationAndUsage>
<Description>KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir.</Description>
</NDC>
<NDC>
<NDCCode>0074-4014-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (0074-4014-12) </PackageDescription>
<NDC11Code>00074-4014-12</NDC11Code>
<ProductNDC>0074-4014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kaletra</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021906</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>200; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .</IndicationAndUsage>
<Description>KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir.</Description>
</NDC>
<NDC>
<NDCCode>0074-6799-22</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (0074-6799-22) </PackageDescription>
<NDC11Code>00074-6799-22</NDC11Code>
<ProductNDC>0074-6799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kaletra</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100618</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021906</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>200; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .</IndicationAndUsage>
<Description>KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Yellow or red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pale yellow or pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir.</Description>
</NDC>
<NDC>
<NDCCode>0527-1947-48</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0527-1947-48) > 160 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00527-1947-48</NDC11Code>
<ProductNDC>0527-1947</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopinavir-ritonavir</ProprietaryName>
<NonProprietaryName>Lopinavir-ritonavir</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207407</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>80; 20</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see Microbiology (12.4)]. .</IndicationAndUsage>
<Description>Lopinavir and Ritonavir Oral Solution USP is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula. Lopinavir and ritonavir oral solution is available for oral administration as 80 mg lopinavir and 20 mg ritonavir per milliliter with the following inactive ingredients: bubble gum flavor, ethanol, glycerin, high fructose corn syrup, malic acid, polyoxyl 40 hydrogenated castor oil, povidone, propylene glycol, sodium hydroxide, sucralose, and water. Lopinavir and ritonavir oral solution contains approximately 42% (v/v) ethanol and approximately 15% (w/v) propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0591-2927-54</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0591-2927-54) / 200 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00591-2927-54</NDC11Code>
<ProductNDC>0591-2927</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol Tartrate Hfa Inhalation</ProprietaryName>
<NonProprietaryName>Levalbuterol Tartrate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161003</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021730</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LEVALBUTEROL TARTRATE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol tartrate HFA inhalation aerosol is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1).</IndicationAndUsage>
<Description>The active component of Levalbuterol tartrate HFA inhalation aerosol is levalbuterol tartrate, the (R)-enantiomer of albuterol. Levalbuterol tartrate is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. Levalbuterol tartrate has the chemical name (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol L-tartrate (2:1 salt), and it has the following chemical structure. The molecular weight of levalbuterol tartrate is 628.71, and its empirical formula is (C13H21NO3)2 · C4H6O6. It is a white to light-yellow solid, freely soluble in water and very slightly soluble in ethanol. Levalbuterol tartrate is the generic name for (R)-albuterol tartrate in the United States. Levalbuterol tartrate HFA inhalation aerosol is a pressurized metered-dose aerosol inhaler (MDI) fitted with a dose indicator, which produces an aerosol for oral inhalation. It contains a suspension of micronized levalbuterol tartrate, propellant HFA-134a (1,1,1,2-tetrafluoroethane), Dehydrated Alcohol USP, and Oleic Acid NF. After priming with 4 actuations, each actuation of the inhaler delivers 67.8 mcg of levalbuterol tartrate (equivalent to 51.6 mcg of levalbuterol free base) from the valve and 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator mouthpiece. Each 15 g canister provides 200 actuations (or inhalations).</Description>
</NDC>
<NDC>
<NDCCode>10135-628-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (10135-628-01)</PackageDescription>
<NDC11Code>10135-0628-01</NDC11Code>
<ProductNDC>10135-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207118</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; CAFFEINE; BUTALBITAL</SubstanceName>
<StrengthNumber>300; 40; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Barbiturates [CS],Barbiturate [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, and caffeine capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients: Butalbital, USP……………………50 mg Acetaminophen, USP…………….300 mg Caffeine, USP……………………..40 mg. Inactive Ingredients: FD&C blue # 1, FD&C red # 40, gelatin, microcrystalline cellulose, stearic acid, talc, titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>10237-628-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10237-628-60) > 170 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0628-60</NDC11Code>
<ProductNDC>10237-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aim Tartar Control</ProprietaryName>
<ProprietaryNameSuffix>Plus Mouthwash And Whitening</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20040301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>