{
"NDC": [
{
"NDCCode": "14049-466-34",
"PackageDescription": "1 TUBE in 1 CARTON (14049-466-34) > 3.5 g in 1 TUBE",
"NDC11Code": "14049-0466-34",
"ProductNDC": "14049-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin And Polymyxin B Sulfates And Dexamethasone",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate, And Dexamethasone",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19940725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064063",
"LabelerName": "RXV",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE",
"StrengthNumber": "3.5; 10000; 1",
"StrengthUnit": "mg/g; [USP'U]/g; mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "14049-464-34",
"PackageDescription": "1 TUBE in 1 CARTON (14049-464-34) > 3.5 g in 1 TUBE",
"NDC11Code": "14049-0464-34",
"ProductNDC": "14049-464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin And Polymyxin B Sulfates And Bacitracin Zinc",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19951030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064064",
"LabelerName": "RXV",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC",
"StrengthNumber": "3.5; 10000; 400",
"StrengthUnit": "mg/g; [USP'U]/g; [USP'U]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "14049-467-34",
"PackageDescription": "1 TUBE in 1 CARTON (14049-467-34) > 3.5 g in 1 TUBE",
"NDC11Code": "14049-0467-34",
"ProductNDC": "14049-467",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone",
"NonProprietaryName": "Neomycin Sulfate And Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19951030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064068",
"LabelerName": "RXV",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE",
"StrengthNumber": "3.5; 10000; 400; 10",
"StrengthUnit": "mg/g; [USP'U]/g; [USP'U]/g; mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49738-466-34",
"PackageDescription": "1 BOTTLE in 1 CARTON (49738-466-34) > 236 mL in 1 BOTTLE",
"NDC11Code": "49738-0466-34",
"ProductNDC": "49738-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Sense Childrens Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140221",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kmart Corporation",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "52685-466-10",
"PackageDescription": "1 CONTAINER in 1 CARTON (52685-466-10) > 34.48 g in 1 CONTAINER",
"NDC11Code": "52685-0466-10",
"ProductNDC": "52685-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Refining Fluid Foundation",
"ProprietaryNameSuffix": "O60",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO CO., LTD.",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "1690",
"StrengthUnit": "mg/34.48g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68001-466-64",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (68001-466-64) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68001-466-63) ",
"NDC11Code": "68001-0466-64",
"ProductNDC": "68001-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204107",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201130",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomem-branous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection, USP is a lyophilized powder for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3 R*,6 S*( S*),7 S*,22 S*,23 R*,26 R*,36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, mono-hydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:."
},
{
"NDCCode": "14049-830-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (14049-830-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "14049-0830-05",
"ProductNDC": "14049-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin Polymyxin B Sulfates And Dexamethasone",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19950913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064135",
"LabelerName": "RXV",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE",
"StrengthNumber": "3.5; 10000; 1",
"StrengthUnit": "mg/mL; [USP'U]/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0168-0269-50",
"PackageDescription": "50 mL in 1 BOTTLE, PLASTIC (0168-0269-50) ",
"NDC11Code": "00168-0269-50",
"ProductNDC": "0168-0269",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075391",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990208",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate topical solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.",
"Description": "Clobetasol propionate topical solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:. Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution USP, 0.05% contains: 0.5 mg/g clobetasol propionate in a base composed of purified water, isopropyl alcohol (39.3%), carbomer 934P and sodium hydroxide (for pH adjustment)."
},
{
"NDCCode": "0299-3847-00",
"PackageDescription": "1 BOTTLE in 1 BLISTER PACK (0299-3847-00) / 15 mL in 1 BOTTLE (0299-3847-05) ",
"NDC11Code": "00299-3847-00",
"ProductNDC": "0299-3847",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040301",
"EndMarketingDate": "20270101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021644",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040301",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"Description": "CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25H 32CIFO 5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate."
},
{
"NDCCode": "0299-3847-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3847-04) / 118 mL in 1 BOTTLE",
"NDC11Code": "00299-3847-04",
"ProductNDC": "0299-3847",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040301",
"EndMarketingDate": "20270101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021644",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040301",
"EndMarketingDatePackage": "20270101",
"SamplePackage": "N",
"Description": "CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25H 32CIFO 5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate."
},
{
"NDCCode": "0299-3848-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3848-02) / 59 mL in 1 BOTTLE",
"NDC11Code": "00299-3848-02",
"ProductNDC": "0299-3848",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021535",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030801",
"SamplePackage": "N",
"IndicationAndUsage": "CLOBEX (clobetasol propionate) Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water."
},
{
"NDCCode": "0299-3848-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3848-04) / 118 mL in 1 BOTTLE",
"NDC11Code": "00299-3848-04",
"ProductNDC": "0299-3848",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021535",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030801",
"SamplePackage": "N",
"IndicationAndUsage": "CLOBEX (clobetasol propionate) Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water."
},
{
"NDCCode": "0299-3849-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3849-01) / 10 mL in 1 BOTTLE",
"NDC11Code": "00299-3849-01",
"ProductNDC": "0299-3849",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20051027",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021835",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051027",
"SamplePackage": "Y",
"Description": "CLOBEX ®(clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "0299-3849-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3849-02) / 59 mL in 1 BOTTLE",
"NDC11Code": "00299-3849-02",
"ProductNDC": "0299-3849",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20051027",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021835",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051027",
"SamplePackage": "N",
"Description": "CLOBEX ®(clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "0299-3849-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3849-04) / 125 mL in 1 BOTTLE",
"NDC11Code": "00299-3849-04",
"ProductNDC": "0299-3849",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20051027",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021835",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051027",
"SamplePackage": "N",
"Description": "CLOBEX ®(clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "0472-0403-94",
"PackageDescription": "1 BOTTLE in 1 CARTON (0472-0403-94) / 118 mL in 1 BOTTLE",
"NDC11Code": "00472-0403-94",
"ProductNDC": "0472-0403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078854",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120103",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older. (1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Avoid any contact with the eyes and lips. (1.2) .",
"Description": "Clobetasol propionate shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate, USP is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate, USP has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32CIFO5. Clobetasol propionate, USP is a white to practically white crystalline, odorless powder insoluble in water. Each gram of clobetasol propionate shampoo, 0.05%, contains 0.5 mg of clobetasol propionate, USP in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol (12.38%), citric acid monohydrate, coco-betaine, polyquaternium 10, purified water, sodium citrate and sodium laureth sulfate."
},
{
"NDCCode": "0472-0404-92",
"PackageDescription": "1 BOTTLE in 1 CARTON (0472-0404-92) > 59 mL in 1 BOTTLE",
"NDC11Code": "00472-0404-92",
"ProductNDC": "0472-0404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078223",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2020-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120102",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol Propionate Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2) , 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2) .",
"Description": "Clobetasol Propionate Lotion, 0.05% contains clobetasol propionate, USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Lotion, 0.05% contains 0.5 mg of clobetasol propionate, USP, in a white liquid composed of carbomer 940, hypromellose, mineral oil, polyoxyethylene glycol 300 isostearate, polysorbate 80, propylene glycol, purified water, and sodium hydroxide."
},
{
"NDCCode": "0472-0404-94",
"PackageDescription": "1 BOTTLE in 1 CARTON (0472-0404-94) > 118 mL in 1 BOTTLE",
"NDC11Code": "00472-0404-94",
"ProductNDC": "0472-0404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078223",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2020-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120102",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol Propionate Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2) , 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2) .",
"Description": "Clobetasol Propionate Lotion, 0.05% contains clobetasol propionate, USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Lotion, 0.05% contains 0.5 mg of clobetasol propionate, USP, in a white liquid composed of carbomer 940, hypromellose, mineral oil, polyoxyethylene glycol 300 isostearate, polysorbate 80, propylene glycol, purified water, and sodium hydroxide."
},
{
"NDCCode": "0574-4135-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0574-4135-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00574-4135-05",
"ProductNDC": "0574-4135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loteprednol Etabonate",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215204",
"LabelerName": "Padagis US LLC",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260112",
"SamplePackage": "N",
"IndicationAndUsage": "Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate ophthalmic suspension is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate ophthalmic suspension experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate ophthalmic suspension and 6% with prednisolone acetate 1%. Loteprednol etabonate ophthalmic suspension should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate ophthalmic suspension is also indicated for the treatment of post-operative inflammation following ocular surgery.",
"Description": "Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Tyloxapol, and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "0574-4135-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0574-4135-10) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00574-4135-10",
"ProductNDC": "0574-4135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loteprednol Etabonate",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215204",
"LabelerName": "Padagis US LLC",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260112",
"SamplePackage": "N",
"IndicationAndUsage": "Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate ophthalmic suspension is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate ophthalmic suspension experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate ophthalmic suspension and 6% with prednisolone acetate 1%. Loteprednol etabonate ophthalmic suspension should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate ophthalmic suspension is also indicated for the treatment of post-operative inflammation following ocular surgery.",
"Description": "Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Tyloxapol, and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "0574-4135-15",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0574-4135-15) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00574-4135-15",
"ProductNDC": "0574-4135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loteprednol Etabonate",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215204",
"LabelerName": "Padagis US LLC",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260112",
"SamplePackage": "N",
"IndicationAndUsage": "Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate ophthalmic suspension is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate ophthalmic suspension experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate ophthalmic suspension and 6% with prednisolone acetate 1%. Loteprednol etabonate ophthalmic suspension should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate ophthalmic suspension is also indicated for the treatment of post-operative inflammation following ocular surgery.",
"Description": "Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Tyloxapol, and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "0591-4039-46",
"PackageDescription": "1 BOTTLE in 1 CARTON (0591-4039-46) / 59 mL in 1 BOTTLE",
"NDC11Code": "00591-4039-46",
"ProductNDC": "0591-4039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150828",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021835",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150828",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"Description": "Clobetasol Propionate Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "0591-4039-74",
"PackageDescription": "1 BOTTLE in 1 CARTON (0591-4039-74) / 125 mL in 1 BOTTLE",
"NDC11Code": "00591-4039-74",
"ProductNDC": "0591-4039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150828",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021835",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150828",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"Description": "Clobetasol Propionate Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "0713-0656-15",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0656-15) / 15 g in 1 TUBE",
"NDC11Code": "00713-0656-15",
"ProductNDC": "0713-0656",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074089",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160414",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol Propionate Ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol Propionate Ointment, USP 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 466.98. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "0713-0656-31",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0656-31) / 30 g in 1 TUBE",
"NDC11Code": "00713-0656-31",
"ProductNDC": "0713-0656",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074089",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160414",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol Propionate Ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol Propionate Ointment, USP 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 466.98. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "0713-0656-37",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0656-37) / 45 g in 1 TUBE",
"NDC11Code": "00713-0656-37",
"ProductNDC": "0713-0656",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074089",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160414",
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"IndicationAndUsage": "Clobetasol Propionate Ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol Propionate Ointment, USP 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 466.98. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "0713-0656-60",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0656-60) / 60 g in 1 TUBE",
"NDC11Code": "00713-0656-60",
"ProductNDC": "0713-0656",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20160104",
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"ApplicationNumber": "ANDA074089",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
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"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160414",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol Propionate Ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol Propionate Ointment, USP 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 466.98. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "10135-803-51",
"PackageDescription": "1 SYRINGE in 1 CARTON (10135-803-51) / 5 mL in 1 SYRINGE",
"NDC11Code": "10135-0803-51",
"ProductNDC": "10135-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Regadenoson",
"NonProprietaryName": "Regadenoson",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218054",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "REGADENOSON",
"StrengthNumber": ".08",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240822",
"SamplePackage": "N",
"IndicationAndUsage": "Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.",
"Description": "Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator [ see ClinicalPharmacology ( 12.1) ]. Regadenoson is chemically described as adenosine, 2-{4-[(methylamino) carbonyl] - 1h-pyrazol-1-yl} adenosine propane-1,2-diol. Its structural formula is. The molecular formula for regadenoson is C15H18N8O5.C3H8O2 and its molecular weight is 466.45. Regadenoson injection is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL pre-filled syringe contains equivalent of 0.08 mg regadenoson as regadenoson propylene glycol solvate, 10.9 mg dibasic sodium phosphate dihydrate, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate, and Water for Injection, with pH between 6.3 and 7.7."
},
{
"NDCCode": "10237-466-25",
"PackageDescription": "25 BAR, CHEWABLE in 1 BOTTLE (10237-466-25) ",
"NDC11Code": "10237-0466-25",
"ProductNDC": "10237-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zicam Cold Remedy Medicated Fruit Drops - Manuka Honey",
"NonProprietaryName": "Zinc Acetate Anhydrous And Zinc Gluconate",
"DosageFormName": "BAR, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20211012",
"EndMarketingDate": "20260201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ZINC ACETATE ANHYDROUS; ZINC GLUCONATE",
"StrengthNumber": "2; 2",
"StrengthUnit": "[hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211012",
"EndMarketingDatePackage": "20260201",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces duration of the common cold and helps relieve nasal congestion. Zicam ®Cold Remedy was not formulated to be effective for flu or allergies."
},
{
"NDCCode": "11344-466-03",
"PackageDescription": "1479 mL in 1 BOTTLE, PLASTIC (11344-466-03) ",
"NDC11Code": "11344-0466-03",
"ProductNDC": "11344-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160217",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160217",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
}
]
}
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<NDCList>
<NDC>
<NDCCode>14049-466-34</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (14049-466-34) > 3.5 g in 1 TUBE</PackageDescription>
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<ProductNDC>14049-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin And Polymyxin B Sulfates And Dexamethasone</ProprietaryName>
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<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19940725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064063</ApplicationNumber>
<LabelerName>RXV</LabelerName>
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<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>14049-464-34</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (14049-464-34) > 3.5 g in 1 TUBE</PackageDescription>
<NDC11Code>14049-0464-34</NDC11Code>
<ProductNDC>14049-464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin And Polymyxin B Sulfates And Bacitracin Zinc</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc</NonProprietaryName>
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<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19951030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064064</ApplicationNumber>
<LabelerName>RXV</LabelerName>
<SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC</SubstanceName>
<StrengthNumber>3.5; 10000; 400</StrengthNumber>
<StrengthUnit>mg/g; [USP'U]/g; [USP'U]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis &amp; Repair [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>14049-467-34</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (14049-467-34) > 3.5 g in 1 TUBE</PackageDescription>
<NDC11Code>14049-0467-34</NDC11Code>
<ProductNDC>14049-467</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate And Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone</NonProprietaryName>
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<StartMarketingDate>19951030</StartMarketingDate>
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<ApplicationNumber>ANDA064068</ApplicationNumber>
<LabelerName>RXV</LabelerName>
<SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE</SubstanceName>
<StrengthNumber>3.5; 10000; 400; 10</StrengthNumber>
<StrengthUnit>mg/g; [USP'U]/g; [USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis &amp; Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49738-466-34</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49738-466-34) > 236 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49738-0466-34</NDC11Code>
<ProductNDC>49738-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Sense Childrens Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140221</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kmart Corporation</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52685-466-10</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (52685-466-10) > 34.48 g in 1 CONTAINER</PackageDescription>
<NDC11Code>52685-0466-10</NDC11Code>
<ProductNDC>52685-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Refining Fluid Foundation</ProprietaryName>
<ProprietaryNameSuffix>O60</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
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<StartMarketingDate>20130201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO CO., LTD.</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>1690</StrengthNumber>
<StrengthUnit>mg/34.48g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68001-466-64</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (68001-466-64) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68001-466-63) </PackageDescription>
<NDC11Code>68001-0466-64</NDC11Code>
<ProductNDC>68001-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204107</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomem-branous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP is a lyophilized powder for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3 R*,6 S*( S*),7 S*,22 S*,23 R*,26 R*,36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, mono-hydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>14049-830-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (14049-830-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>14049-0830-05</NDC11Code>
<ProductNDC>14049-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin Polymyxin B Sulfates And Dexamethasone</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19950913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064135</ApplicationNumber>
<LabelerName>RXV</LabelerName>
<SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE</SubstanceName>
<StrengthNumber>3.5; 10000; 1</StrengthNumber>
<StrengthUnit>mg/mL; [USP'U]/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0168-0269-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, PLASTIC (0168-0269-50) </PackageDescription>
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<IndicationAndUsage>Clobetasol propionate topical solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.</IndicationAndUsage>
<Description>Clobetasol propionate topical solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:. Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution USP, 0.05% contains: 0.5 mg/g clobetasol propionate in a base composed of purified water, isopropyl alcohol (39.3%), carbomer 934P and sodium hydroxide (for pH adjustment).</Description>
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<Description>CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25H 32CIFO 5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.</Description>
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<Description>CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25H 32CIFO 5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.</Description>
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<LabelerName>Galderma Laboratories, L.P.</LabelerName>
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<IndicationAndUsage>CLOBEX (clobetasol propionate) Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.</Description>
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<IndicationAndUsage>CLOBEX (clobetasol propionate) Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.</Description>
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<SamplePackage>Y</SamplePackage>
<Description>CLOBEX ®(clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
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<Description>CLOBEX ®(clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
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<Description>CLOBEX ®(clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
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<IndicationAndUsage>Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older. (1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Avoid any contact with the eyes and lips. (1.2) .</IndicationAndUsage>
<Description>Clobetasol propionate shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate, USP is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate, USP has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32CIFO5. Clobetasol propionate, USP is a white to practically white crystalline, odorless powder insoluble in water. Each gram of clobetasol propionate shampoo, 0.05%, contains 0.5 mg of clobetasol propionate, USP in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol (12.38%), citric acid monohydrate, coco-betaine, polyquaternium 10, purified water, sodium citrate and sodium laureth sulfate.</Description>
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<IndicationAndUsage>Clobetasol Propionate Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2) , 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2) .</IndicationAndUsage>
<Description>Clobetasol Propionate Lotion, 0.05% contains clobetasol propionate, USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Lotion, 0.05% contains 0.5 mg of clobetasol propionate, USP, in a white liquid composed of carbomer 940, hypromellose, mineral oil, polyoxyethylene glycol 300 isostearate, polysorbate 80, propylene glycol, purified water, and sodium hydroxide.</Description>
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<IndicationAndUsage>Clobetasol Propionate Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2) , 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2) .</IndicationAndUsage>
<Description>Clobetasol Propionate Lotion, 0.05% contains clobetasol propionate, USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Lotion, 0.05% contains 0.5 mg of clobetasol propionate, USP, in a white liquid composed of carbomer 940, hypromellose, mineral oil, polyoxyethylene glycol 300 isostearate, polysorbate 80, propylene glycol, purified water, and sodium hydroxide.</Description>
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<Description>Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Tyloxapol, and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.</Description>
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<Description>Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Tyloxapol, and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.</Description>
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<IndicationAndUsage>Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate ophthalmic suspension is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate ophthalmic suspension experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate ophthalmic suspension and 6% with prednisolone acetate 1%. Loteprednol etabonate ophthalmic suspension should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate ophthalmic suspension is also indicated for the treatment of post-operative inflammation following ocular surgery.</IndicationAndUsage>
<Description>Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Tyloxapol, and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.</Description>
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<Description>Clobetasol Propionate Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
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<IndicationAndUsage>Clobetasol Propionate Ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Ointment, USP 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 466.98. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
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<Description>Clobetasol Propionate Ointment, USP 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 466.98. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
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<Description>Clobetasol Propionate Ointment, USP 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 466.98. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol Propionate Ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Ointment, USP 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 466.98. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>10135-803-51</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (10135-803-51) / 5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>10135-0803-51</NDC11Code>
<ProductNDC>10135-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Regadenoson</ProprietaryName>
<NonProprietaryName>Regadenoson</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218054</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>REGADENOSON</SubstanceName>
<StrengthNumber>.08</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.</IndicationAndUsage>
<Description>Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator [ see ClinicalPharmacology ( 12.1) ]. Regadenoson is chemically described as adenosine, 2-{4-[(methylamino) carbonyl] - 1h-pyrazol-1-yl} adenosine propane-1,2-diol. Its structural formula is. The molecular formula for regadenoson is C15H18N8O5.C3H8O2 and its molecular weight is 466.45. Regadenoson injection is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL pre-filled syringe contains equivalent of 0.08 mg regadenoson as regadenoson propylene glycol solvate, 10.9 mg dibasic sodium phosphate dihydrate, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate, and Water for Injection, with pH between 6.3 and 7.7.</Description>
</NDC>
<NDC>
<NDCCode>10237-466-25</NDCCode>
<PackageDescription>25 BAR, CHEWABLE in 1 BOTTLE (10237-466-25) </PackageDescription>
<NDC11Code>10237-0466-25</NDC11Code>
<ProductNDC>10237-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zicam Cold Remedy Medicated Fruit Drops - Manuka Honey</ProprietaryName>
<NonProprietaryName>Zinc Acetate Anhydrous And Zinc Gluconate</NonProprietaryName>
<DosageFormName>BAR, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211012</StartMarketingDate>
<EndMarketingDate>20260201</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>ZINC ACETATE ANHYDROUS; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>2; 2</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211012</StartMarketingDatePackage>
<EndMarketingDatePackage>20260201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduces duration of the common cold and helps relieve nasal congestion. Zicam ®Cold Remedy was not formulated to be effective for flu or allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11344-466-03</NDCCode>
<PackageDescription>1479 mL in 1 BOTTLE, PLASTIC (11344-466-03) </PackageDescription>
<NDC11Code>11344-0466-03</NDC11Code>
<ProductNDC>11344-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
</NDCList>