{
"NDC": [
{
"NDCCode": "45802-303-21",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (45802-303-21) > 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "45802-0303-21",
"ProductNDC": "45802-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088832",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-303-67",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (45802-303-67) > 24 TABLET in 1 BLISTER PACK",
"NDC11Code": "45802-0303-67",
"ProductNDC": "45802-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088832",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-433-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-433-21) / 89 mL in 1 BOTTLE",
"NDC11Code": "45802-0433-21",
"ProductNDC": "45802-433",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dextromethorphan Polistirex Extended Release",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20120910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120910",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep."
},
{
"NDCCode": "45802-733-21",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (45802-733-21) > 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "45802-0733-21",
"ProductNDC": "45802-733",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20061002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080292",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "24236-303-21",
"PackageDescription": "120 TABLET, FILM COATED in 1 CANISTER (24236-303-21)",
"NDC11Code": "24236-0303-21",
"ProductNDC": "24236-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Truvada",
"NonProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021752",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "EMTRICITABINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49035-303-21",
"PackageDescription": "88 mL in 1 BOTTLE, PLASTIC (49035-303-21) ",
"NDC11Code": "49035-0303-21",
"ProductNDC": "49035-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ethyl Alcohol",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180705",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Wal-Mart Stores, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "620",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180705",
"SamplePackage": "N"
},
{
"NDCCode": "52301-303-21",
"PackageDescription": "12 TABLET in 1 BAG (52301-303-21) ",
"NDC11Code": "52301-0303-21",
"ProductNDC": "52301-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Formula 303",
"NonProprietaryName": "Valerian Root, Passiflora, Magnesium Carbonate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900919",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Dee Cee Laboratories",
"SubstanceName": "PASSIFLORA INCARNATA FLOWER; MAGNESIUM CARBONATE; VALERIAN",
"StrengthNumber": "3; 1; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170623",
"SamplePackage": "Y",
"IndicationAndUsage": "MUSCLE SPASM: As a muscle relaxant, two tablets every three hours until relief is obtained. Then two tablets with each meal and two and bedtime. TENSION AND STRESS: As a relaxant, two tablets with each meal and two at bedtime."
},
{
"NDCCode": "52959-303-21",
"PackageDescription": "21 TABLET, FILM COATED in 1 BOTTLE (52959-303-21)",
"NDC11Code": "52959-0303-21",
"ProductNDC": "52959-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077135",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Valacyclovir hydrochloride tablets are a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir hydrochloride tablets are blue, film-coated tablets for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue #2, hydrogenated castor oil, hypromellose, polyethylene glycol, polysorbate 80, starch (corn), and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4HCland a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "54295-303-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (54295-303-21) / 454 g in 1 BOTTLE",
"NDC11Code": "54295-0303-21",
"ProductNDC": "54295-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121210",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Trinity Pharmaceuticals, LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "60",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20121210",
"SamplePackage": "N",
"IndicationAndUsage": "For Dermatologic Use: Salicylic Acid 6% is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles). For Podiatric Use: Salicylic Acid 6% is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.",
"Description": "Salicylic Acid 6% Cream contains 6% salicylic acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of trolamine, purified water, methyl paraben, propyl paraben, phenoxyethanol, PEG 100 stearate, mineral oil, glyceryl stearate SE, dimethicone 350, ammonium lactate, disodium EDTA, glycerin, cetearyl alcohol (and) PEG-3, distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol and cetearyl alcohol. Salicylic Acid 6% Lotion contains 6% w/w salicylic acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of trolamine, purified water, methyl paraben, propyl paraben, PEG 100 stearate, cetyl alcohol, mineral oil, glyceryl stearate SE, dimethicone 350, ammonium lactate, disodium EDTA, glycerine, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60."
},
{
"NDCCode": "57716-001-21",
"PackageDescription": "303 L in 1 CYLINDER (57716-001-21) ",
"NDC11Code": "57716-0001-21",
"ProductNDC": "57716-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20040401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206023",
"LabelerName": "Sky Oxygen",
"SubstanceName": "OXYGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040401",
"SamplePackage": "N"
},
{
"NDCCode": "61727-303-21",
"PackageDescription": "4 g in 1 TUBE (61727-303-21) ",
"NDC11Code": "61727-0303-21",
"ProductNDC": "61727-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Relief",
"NonProprietaryName": "Aconitum Napellus, Onion, Arnica Montana, Atropa Belladonna, Solanum Dulcamara Top, Eupatorium Cannabinum, Gelsemium Sempervirens Root",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120705",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; EUPATORIUM CANNABINUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ONION; SOLANUM DULCAMARA TOP",
"StrengthNumber": "14; 8; 8; 8; 18; 8; 8",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120705",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "63323-303-55",
"PackageDescription": "6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-55) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-21) ",
"NDC11Code": "63323-0303-55",
"ProductNDC": "63323-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin Sulfate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20051123",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050789",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "TOBRAMYCIN SULFATE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-02-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051123",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin for Injection, is an aminoglycoside antibacterial indicated for the treatment of serious bacterial infections caused by susceptible isolates of the designated bacteria in the diseases listed below (1.1): : 1 Septicemia in the pediatric patient and adults caused by P. aeruginosa, E. coli, and Klebsiella species (spp). , 2 Lower respiratory tract infections caused by P. aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, E. coli, and S. aureus, 3 Serious central nervous system infections (meningitis) caused by susceptible organisms. , 4 Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella spp., and Enterobacter spp. , 5 Skin, bone, and skin structure infections caused by P. aeruginosa, Proteus spp, E. coli, Klebsiella spp., Enterobacter spp., and S. aureus. Complicated urinary tract infections caused by P. aeruginosa, Proteus spp., (indole-positive and indole-negative), E. coli, Klebsiella spp., .",
"Description": "Tobramycin sulfate, a water-soluble aminoglycoside antibacterial, drug derived from the actinomycete Streptomyces tenebrarius. Tobramycin for Injection, USP is supplied as a sterile powder in a pharmacy bulk package vial for intravenous use. It is intended for reconstitution with 30 mL of Sterile Water for Injection, USP. Each vial contains tobramycin sulfate equivalent to 1.2 g of tobramycin. After reconstitution, the solution will contain 40 mg of tobramycin per mL. The product contains no preservative or sodium bisulfite. Tobramycin sulfate is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine, sulfate (2:5)(salt) and has the molecular formula (C18H37N5O9)25H2SO4. The molecular weight is 1425.42 g/mol. The molecular weight of the free base is 467.51 g/mol. The structural formula of tobramycin, free base, is as follows:. Figure 2: Tobramycin Structure."
},
{
"NDCCode": "79310-303-21",
"PackageDescription": "5000 mL in 1 BOTTLE, PUMP (79310-303-21) ",
"NDC11Code": "79310-0303-21",
"ProductNDC": "79310-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sterizar",
"ProprietaryNameSuffix": "Advanced Barrier Control Bactericidal Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Unicorn Media Partners LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "16",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201101",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer Gel. For Hand Sanitizing to Decrease Bacteria On Skin. Safe for Repeated Use. For use when soap and water not available."
},
{
"NDCCode": "45802-580-01",
"PackageDescription": "1 PATCH, EXTENDED RELEASE in 1 POUCH (45802-580-01) ",
"NDC11Code": "45802-0580-01",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170613",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "45802-580-46",
"PackageDescription": "10 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH",
"NDC11Code": "45802-0580-46",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170613",
"EndMarketingDate": "20280630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170613",
"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "45802-580-62",
"PackageDescription": "24 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH",
"NDC11Code": "45802-0580-62",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170613",
"EndMarketingDate": "20280630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170613",
"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "45802-580-84",
"PackageDescription": "4 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH",
"NDC11Code": "45802-0580-84",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170613",
"EndMarketingDate": "20280630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170613",
"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "45802-004-02",
"PackageDescription": "1 TUBE in 1 CARTON (45802-004-02) / 20 g in 1 TUBE",
"NDC11Code": "45802-0004-02",
"ProductNDC": "45802-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085025",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070131",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.",
"Description": "Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C21H3O05) and is represented by the following structural formula. Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents."
},
{
"NDCCode": "45802-004-03",
"PackageDescription": "1 TUBE in 1 CARTON (45802-004-03) / 28 g in 1 TUBE",
"NDC11Code": "45802-0004-03",
"ProductNDC": "45802-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085025",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060331",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.",
"Description": "Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C21H3O05) and is represented by the following structural formula. Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents."
},
{
"NDCCode": "45802-009-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE",
"NDC11Code": "45802-0009-10",
"ProductNDC": "45802-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202849",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171004",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide oil ear drops is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older.",
"Description": "Fluocinolone Acetonide Oil, 0.01% Ear Drops contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16, 17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide oil ear drops contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone acetonide oil ear drops is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide oil ear drops is heated just below 232°C (450°F) for at least 15 minutes."
},
{
"NDCCode": "45802-014-02",
"PackageDescription": "1 TUBE in 1 CARTON (45802-014-02) / 20 g in 1 TUBE",
"NDC11Code": "45802-0014-02",
"ProductNDC": "45802-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085027",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060613",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.",
"Description": "Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C21H3O05) and is represented by the following structural formula. Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents."
},
{
"NDCCode": "45802-014-05",
"PackageDescription": "454 g in 1 JAR (45802-014-05) ",
"NDC11Code": "45802-0014-05",
"ProductNDC": "45802-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085027",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061219",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.",
"Description": "Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C21H3O05) and is represented by the following structural formula. Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents."
},
{
"NDCCode": "45802-018-14",
"PackageDescription": "1 TUBE in 1 CARTON (45802-018-14) / 15 g in 1 TUBE",
"NDC11Code": "45802-0018-14",
"ProductNDC": "45802-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mupirocin",
"NonProprietaryName": "Mupirocin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220906",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212465",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "MUPIROCIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220906",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).",
"Description": "Mupirocin Cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (αE,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-metylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium is (C26H43O9)2Ca2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium, is. Each gram of mupirocin cream USP contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium. The inactive ingredients are benzyl alcohol, mono and di-glycerides, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water and xanthan gum."
},
{
"NDCCode": "45802-018-94",
"PackageDescription": "1 TUBE in 1 CARTON (45802-018-94) / 30 g in 1 TUBE",
"NDC11Code": "45802-0018-94",
"ProductNDC": "45802-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mupirocin",
"NonProprietaryName": "Mupirocin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220906",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212465",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "MUPIROCIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220906",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).",
"Description": "Mupirocin Cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (αE,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-metylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium is (C26H43O9)2Ca2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium, is. Each gram of mupirocin cream USP contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium. The inactive ingredients are benzyl alcohol, mono and di-glycerides, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water and xanthan gum."
},
{
"NDCCode": "45802-021-46",
"PackageDescription": "56.2 g in 1 BOTTLE, PLASTIC (45802-021-46) ",
"NDC11Code": "45802-0021-46",
"ProductNDC": "45802-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072538",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060630",
"SamplePackage": "N",
"IndicationAndUsage": "Betamethasone Dipropionate Lotion USP, 0.05% is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.",
"Description": "Betamethasone Dipropionate Lotion USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Lotion USP, 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a lotion base of carbomer homopolymer type B, isopropyl alcohol, and purified water. Sodium hydroxide is used to adjust pH."
},
{
"NDCCode": "45802-045-01",
"PackageDescription": "63 g in 1 CAN (45802-045-01) ",
"NDC11Code": "45802-0045-01",
"ProductNDC": "45802-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205782",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".147",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150417",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The structural formula is. A two-second application, which covers an area approximately the size of the hand, delivers an amount of triamcinolone acetonide not exceeding 0.2 mg. After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant."
},
{
"NDCCode": "45802-045-02",
"PackageDescription": "100 g in 1 CAN (45802-045-02) ",
"NDC11Code": "45802-0045-02",
"ProductNDC": "45802-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205782",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".147",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150420",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The structural formula is. A two-second application, which covers an area approximately the size of the hand, delivers an amount of triamcinolone acetonide not exceeding 0.2 mg. After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant."
},
{
"NDCCode": "45802-049-35",
"PackageDescription": "1 TUBE in 1 CARTON (45802-049-35) / 15 g in 1 TUBE",
"NDC11Code": "45802-0049-35",
"ProductNDC": "45802-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20061110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087385",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061110",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11β,16α)-. C24H31FO6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum."
},
{
"NDCCode": "45802-053-01",
"PackageDescription": "1 CAN in 1 CARTON (45802-053-01) / 50 g in 1 CAN",
"NDC11Code": "45802-0053-01",
"ProductNDC": "45802-053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Valerate",
"NonProprietaryName": "Betamethasone Valerate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078337",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE VALERATE",
"StrengthNumber": "1.2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130115",
"SamplePackage": "N",
"IndicationAndUsage": "Betamethasone Valerate Foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.",
"Description": "Betamethasone Valerate Foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents. Betamethasone valerate is 9-fluoro11ß,17, 21-trihydroxy-16ß-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C27H37FO6, a molecular weight of 476.58. The following is the chemical structure. Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether. Betamethasone Valerate Foam, 0.12% contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant."
},
{
"NDCCode": "45802-053-02",
"PackageDescription": "1 CAN in 1 CARTON (45802-053-02) / 100 g in 1 CAN",
"NDC11Code": "45802-0053-02",
"ProductNDC": "45802-053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Valerate",
"NonProprietaryName": "Betamethasone Valerate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078337",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE VALERATE",
"StrengthNumber": "1.2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130115",
"SamplePackage": "N",
"IndicationAndUsage": "Betamethasone Valerate Foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.",
"Description": "Betamethasone Valerate Foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents. Betamethasone valerate is 9-fluoro11ß,17, 21-trihydroxy-16ß-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C27H37FO6, a molecular weight of 476.58. The following is the chemical structure. Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether. Betamethasone Valerate Foam, 0.12% contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>45802-303-21</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (45802-303-21) > 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>45802-0303-21</NDC11Code>
<ProductNDC>45802-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088832</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-303-67</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (45802-303-67) > 24 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>45802-0303-67</NDC11Code>
<ProductNDC>45802-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088832</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-433-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-433-21) / 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0433-21</NDC11Code>
<ProductNDC>45802-433</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dextromethorphan Polistirex Extended Release</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-733-21</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (45802-733-21) > 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>45802-0733-21</NDC11Code>
<ProductNDC>45802-733</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080292</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>24236-303-21</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 CANISTER (24236-303-21)</PackageDescription>
<NDC11Code>24236-0303-21</NDC11Code>
<ProductNDC>24236-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Truvada</ProprietaryName>
<NonProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021752</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>EMTRICITABINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49035-303-21</NDCCode>
<PackageDescription>88 mL in 1 BOTTLE, PLASTIC (49035-303-21) </PackageDescription>
<NDC11Code>49035-0303-21</NDC11Code>
<ProductNDC>49035-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ethyl Alcohol</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180705</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>620</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52301-303-21</NDCCode>
<PackageDescription>12 TABLET in 1 BAG (52301-303-21) </PackageDescription>
<NDC11Code>52301-0303-21</NDC11Code>
<ProductNDC>52301-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Formula 303</ProprietaryName>
<NonProprietaryName>Valerian Root, Passiflora, Magnesium Carbonate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900919</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Dee Cee Laboratories</LabelerName>
<SubstanceName>PASSIFLORA INCARNATA FLOWER; MAGNESIUM CARBONATE; VALERIAN</SubstanceName>
<StrengthNumber>3; 1; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170623</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MUSCLE SPASM: As a muscle relaxant, two tablets every three hours until relief is obtained. Then two tablets with each meal and two and bedtime. TENSION AND STRESS: As a relaxant, two tablets with each meal and two at bedtime.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52959-303-21</NDCCode>
<PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (52959-303-21)</PackageDescription>
<NDC11Code>52959-0303-21</NDC11Code>
<ProductNDC>52959-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077135</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Valacyclovir hydrochloride tablets are a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir hydrochloride tablets are blue, film-coated tablets for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue #2, hydrogenated castor oil, hypromellose, polyethylene glycol, polysorbate 80, starch (corn), and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4HCland a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>54295-303-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (54295-303-21) / 454 g in 1 BOTTLE</PackageDescription>
<NDC11Code>54295-0303-21</NDC11Code>
<ProductNDC>54295-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121210</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Trinity Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For Dermatologic Use: Salicylic Acid 6% is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles). For Podiatric Use: Salicylic Acid 6% is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.</IndicationAndUsage>
<Description>Salicylic Acid 6% Cream contains 6% salicylic acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of trolamine, purified water, methyl paraben, propyl paraben, phenoxyethanol, PEG 100 stearate, mineral oil, glyceryl stearate SE, dimethicone 350, ammonium lactate, disodium EDTA, glycerin, cetearyl alcohol (and) PEG-3, distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol and cetearyl alcohol. Salicylic Acid 6% Lotion contains 6% w/w salicylic acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of trolamine, purified water, methyl paraben, propyl paraben, PEG 100 stearate, cetyl alcohol, mineral oil, glyceryl stearate SE, dimethicone 350, ammonium lactate, disodium EDTA, glycerine, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60.</Description>
</NDC>
<NDC>
<NDCCode>57716-001-21</NDCCode>
<PackageDescription>303 L in 1 CYLINDER (57716-001-21) </PackageDescription>
<NDC11Code>57716-0001-21</NDC11Code>
<ProductNDC>57716-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20040401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206023</ApplicationNumber>
<LabelerName>Sky Oxygen</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61727-303-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-303-21) </PackageDescription>
<NDC11Code>61727-0303-21</NDC11Code>
<ProductNDC>61727-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Onion, Arnica Montana, Atropa Belladonna, Solanum Dulcamara Top, Eupatorium Cannabinum, Gelsemium Sempervirens Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120705</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; EUPATORIUM CANNABINUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ONION; SOLANUM DULCAMARA TOP</SubstanceName>
<StrengthNumber>14; 8; 8; 8; 18; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63323-303-55</NDCCode>
<PackageDescription>6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-55) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-21) </PackageDescription>
<NDC11Code>63323-0303-55</NDC11Code>
<ProductNDC>63323-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20051123</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050789</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>TOBRAMYCIN SULFATE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin for Injection, is an aminoglycoside antibacterial indicated for the treatment of serious bacterial infections caused by susceptible isolates of the designated bacteria in the diseases listed below (1.1): : 1 Septicemia in the pediatric patient and adults caused by P. aeruginosa, E. coli, and Klebsiella species (spp). , 2 Lower respiratory tract infections caused by P. aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, E. coli, and S. aureus, 3 Serious central nervous system infections (meningitis) caused by susceptible organisms. , 4 Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella spp., and Enterobacter spp. , 5 Skin, bone, and skin structure infections caused by P. aeruginosa, Proteus spp, E. coli, Klebsiella spp., Enterobacter spp., and S. aureus. Complicated urinary tract infections caused by P. aeruginosa, Proteus spp., (indole-positive and indole-negative), E. coli, Klebsiella spp., .</IndicationAndUsage>
<Description>Tobramycin sulfate, a water-soluble aminoglycoside antibacterial, drug derived from the actinomycete Streptomyces tenebrarius. Tobramycin for Injection, USP is supplied as a sterile powder in a pharmacy bulk package vial for intravenous use. It is intended for reconstitution with 30 mL of Sterile Water for Injection, USP. Each vial contains tobramycin sulfate equivalent to 1.2 g of tobramycin. After reconstitution, the solution will contain 40 mg of tobramycin per mL. The product contains no preservative or sodium bisulfite. Tobramycin sulfate is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine, sulfate (2:5)(salt) and has the molecular formula (C18H37N5O9)25H2SO4. The molecular weight is 1425.42 g/mol. The molecular weight of the free base is 467.51 g/mol. The structural formula of tobramycin, free base, is as follows:. Figure 2: Tobramycin Structure.</Description>
</NDC>
<NDC>
<NDCCode>79310-303-21</NDCCode>
<PackageDescription>5000 mL in 1 BOTTLE, PUMP (79310-303-21) </PackageDescription>
<NDC11Code>79310-0303-21</NDC11Code>
<ProductNDC>79310-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sterizar</ProprietaryName>
<ProprietaryNameSuffix>Advanced Barrier Control Bactericidal Hand Sanitizer</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Unicorn Media Partners LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer Gel. For Hand Sanitizing to Decrease Bacteria On Skin. Safe for Repeated Use. For use when soap and water not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-580-01</NDCCode>
<PackageDescription>1 PATCH, EXTENDED RELEASE in 1 POUCH (45802-580-01) </PackageDescription>
<NDC11Code>45802-0580-01</NDC11Code>
<ProductNDC>45802-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scopolamine Transdermal System</ProprietaryName>
<NonProprietaryName>Scopolamine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078830</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>45802-580-46</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH</PackageDescription>
<NDC11Code>45802-0580-46</NDC11Code>
<ProductNDC>45802-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scopolamine Transdermal System</ProprietaryName>
<NonProprietaryName>Scopolamine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170613</StartMarketingDate>
<EndMarketingDate>20280630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078830</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170613</StartMarketingDatePackage>
<EndMarketingDatePackage>20280630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>45802-580-62</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH</PackageDescription>
<NDC11Code>45802-0580-62</NDC11Code>
<ProductNDC>45802-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scopolamine Transdermal System</ProprietaryName>
<NonProprietaryName>Scopolamine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170613</StartMarketingDate>
<EndMarketingDate>20280630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078830</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170613</StartMarketingDatePackage>
<EndMarketingDatePackage>20280630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>45802-580-84</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH</PackageDescription>
<NDC11Code>45802-0580-84</NDC11Code>
<ProductNDC>45802-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scopolamine Transdermal System</ProprietaryName>
<NonProprietaryName>Scopolamine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170613</StartMarketingDate>
<EndMarketingDate>20280630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078830</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170613</StartMarketingDatePackage>
<EndMarketingDatePackage>20280630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>45802-004-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-004-02) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0004-02</NDC11Code>
<ProductNDC>45802-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085025</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.</IndicationAndUsage>
<Description>Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C21H3O05) and is represented by the following structural formula. Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.</Description>
</NDC>
<NDC>
<NDCCode>45802-004-03</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-004-03) / 28 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0004-03</NDC11Code>
<ProductNDC>45802-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085025</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.</IndicationAndUsage>
<Description>Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C21H3O05) and is represented by the following structural formula. Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.</Description>
</NDC>
<NDC>
<NDCCode>45802-009-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0009-10</NDC11Code>
<ProductNDC>45802-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202849</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide oil ear drops is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Oil, 0.01% Ear Drops contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16, 17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide oil ear drops contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone acetonide oil ear drops is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide oil ear drops is heated just below 232°C (450°F) for at least 15 minutes.</Description>
</NDC>
<NDC>
<NDCCode>45802-014-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-014-02) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0014-02</NDC11Code>
<ProductNDC>45802-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085027</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.</IndicationAndUsage>
<Description>Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C21H3O05) and is represented by the following structural formula. Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.</Description>
</NDC>
<NDC>
<NDCCode>45802-014-05</NDCCode>
<PackageDescription>454 g in 1 JAR (45802-014-05) </PackageDescription>
<NDC11Code>45802-0014-05</NDC11Code>
<ProductNDC>45802-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085027</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.</IndicationAndUsage>
<Description>Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C21H3O05) and is represented by the following structural formula. Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.</Description>
</NDC>
<NDC>
<NDCCode>45802-018-14</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-018-14) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0018-14</NDC11Code>
<ProductNDC>45802-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mupirocin</ProprietaryName>
<NonProprietaryName>Mupirocin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220906</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212465</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>MUPIROCIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220906</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).</IndicationAndUsage>
<Description>Mupirocin Cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (αE,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-metylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium is (C26H43O9)2Ca2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium, is. Each gram of mupirocin cream USP contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium. The inactive ingredients are benzyl alcohol, mono and di-glycerides, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>45802-018-94</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-018-94) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0018-94</NDC11Code>
<ProductNDC>45802-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mupirocin</ProprietaryName>
<NonProprietaryName>Mupirocin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220906</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212465</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>MUPIROCIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220906</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).</IndicationAndUsage>
<Description>Mupirocin Cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (αE,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-metylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium is (C26H43O9)2Ca2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium, is. Each gram of mupirocin cream USP contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium. The inactive ingredients are benzyl alcohol, mono and di-glycerides, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>45802-021-46</NDCCode>
<PackageDescription>56.2 g in 1 BOTTLE, PLASTIC (45802-021-46) </PackageDescription>
<NDC11Code>45802-0021-46</NDC11Code>
<ProductNDC>45802-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072538</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betamethasone Dipropionate Lotion USP, 0.05% is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.</IndicationAndUsage>
<Description>Betamethasone Dipropionate Lotion USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Lotion USP, 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a lotion base of carbomer homopolymer type B, isopropyl alcohol, and purified water. Sodium hydroxide is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>45802-045-01</NDCCode>
<PackageDescription>63 g in 1 CAN (45802-045-01) </PackageDescription>
<NDC11Code>45802-0045-01</NDC11Code>
<ProductNDC>45802-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205782</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.147</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The structural formula is. A two-second application, which covers an area approximately the size of the hand, delivers an amount of triamcinolone acetonide not exceeding 0.2 mg. After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant.</Description>
</NDC>
<NDC>
<NDCCode>45802-045-02</NDCCode>
<PackageDescription>100 g in 1 CAN (45802-045-02) </PackageDescription>
<NDC11Code>45802-0045-02</NDC11Code>
<ProductNDC>45802-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205782</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.147</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The structural formula is. A two-second application, which covers an area approximately the size of the hand, delivers an amount of triamcinolone acetonide not exceeding 0.2 mg. After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant.</Description>
</NDC>
<NDC>
<NDCCode>45802-049-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-049-35) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0049-35</NDC11Code>
<ProductNDC>45802-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20061110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087385</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11β,16α)-. C24H31FO6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>45802-053-01</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (45802-053-01) / 50 g in 1 CAN</PackageDescription>
<NDC11Code>45802-0053-01</NDC11Code>
<ProductNDC>45802-053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Valerate</ProprietaryName>
<NonProprietaryName>Betamethasone Valerate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078337</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE VALERATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betamethasone Valerate Foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.</IndicationAndUsage>
<Description>Betamethasone Valerate Foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents. Betamethasone valerate is 9-fluoro11ß,17, 21-trihydroxy-16ß-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C27H37FO6, a molecular weight of 476.58. The following is the chemical structure. Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether. Betamethasone Valerate Foam, 0.12% contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.</Description>
</NDC>
<NDC>
<NDCCode>45802-053-02</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (45802-053-02) / 100 g in 1 CAN</PackageDescription>
<NDC11Code>45802-0053-02</NDC11Code>
<ProductNDC>45802-053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Valerate</ProprietaryName>
<NonProprietaryName>Betamethasone Valerate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078337</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE VALERATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betamethasone Valerate Foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.</IndicationAndUsage>
<Description>Betamethasone Valerate Foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents. Betamethasone valerate is 9-fluoro11ß,17, 21-trihydroxy-16ß-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C27H37FO6, a molecular weight of 476.58. The following is the chemical structure. Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether. Betamethasone Valerate Foam, 0.12% contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.</Description>
</NDC>
</NDCList>