{
"NDC": [
{
"NDCCode": "50383-859-21",
"PackageDescription": "4 TRAY in 1 CASE (50383-859-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-859-20) ",
"NDC11Code": "50383-0859-21",
"ProductNDC": "50383-859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203960",
"LabelerName": "Akorn",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170609",
"SamplePackage": "N"
},
{
"NDCCode": "50383-286-21",
"PackageDescription": "4 TRAY in 1 CASE (50383-286-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-286-20) ",
"NDC11Code": "50383-0286-21",
"ProductNDC": "50383-286",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091678",
"LabelerName": "Akorn",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150211",
"SamplePackage": "N"
},
{
"NDCCode": "50383-824-21",
"PackageDescription": "4 TRAY in 1 CASE (50383-824-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-824-20) ",
"NDC11Code": "50383-0824-21",
"ProductNDC": "50383-824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19971229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074650",
"LabelerName": "Akorn Operating Company LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20141224",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against Pneumocystis jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis jiroveci pneumonia. Traveler’s Diarrhea In Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim oral suspension is a synthetic antibacterial combination product available for oral administration, with each teaspoonful (5 mL) containing 200 mg sulfamethoxazole and 40 mg trimethoprim. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor."
},
{
"NDCCode": "50383-859-11",
"PackageDescription": "4 TRAY in 1 CASE (50383-859-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-859-10) ",
"NDC11Code": "50383-0859-11",
"ProductNDC": "50383-859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203960",
"LabelerName": "Akorn",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170609",
"SamplePackage": "N"
},
{
"NDCCode": "50383-859-12",
"PackageDescription": "10 TRAY in 1 CASE (50383-859-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-859-10) ",
"NDC11Code": "50383-0859-12",
"ProductNDC": "50383-859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203960",
"LabelerName": "Akorn",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170609",
"SamplePackage": "N"
},
{
"NDCCode": "50383-859-22",
"PackageDescription": "10 TRAY in 1 CASE (50383-859-22) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-859-20) ",
"NDC11Code": "50383-0859-22",
"ProductNDC": "50383-859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203960",
"LabelerName": "Akorn",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170609",
"SamplePackage": "N"
},
{
"NDCCode": "50383-859-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-859-24) > 240 mL in 1 BOTTLE",
"NDC11Code": "50383-0859-24",
"ProductNDC": "50383-859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203960",
"LabelerName": "Akorn",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170609",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).",
"Description": "Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17α-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 µg per mL, solubility in plasma is 24 µg per mL. Its molecular weight is 384.51. The empirical formula is C24H32O4 and the structural formula is represented as follows. megestrol acetate, USP. Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: citric acid, natural and artificial lemon-lime flavor, polyethylene glycol, polysorbate 80, purified water, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "13537-859-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-859-02) > 30 g in 1 TUBE (13537-859-01)",
"NDC11Code": "13537-0859-02",
"ProductNDC": "13537-859",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Instant Perfection 3 En 1 Face Refining Foundation Spf 25",
"ProprietaryNameSuffix": "Medio 5 - Beige",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".065; .036",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-859-02",
"PackageDescription": "1 BOTTLE in 1 BOX (14783-859-02) > 30 mL in 1 BOTTLE (14783-859-01)",
"NDC11Code": "14783-0859-02",
"ProductNDC": "14783-859",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm",
"ProprietaryNameSuffix": "Claire 4 - Beige",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151123",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".07; .0244",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "68084-859-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-859-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-859-11) ",
"NDC11Code": "68084-0859-01",
"ProductNDC": "68084-859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078993",
"LabelerName": "American Health Packaging",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150204",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red. Meets USP dissolution test 2."
},
{
"NDCCode": "50383-018-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-018-04) > 118 mL in 1 BOTTLE",
"NDC11Code": "50383-0018-04",
"ProductNDC": "50383-018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eye Wash",
"NonProprietaryName": "Eye Wash",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "INTRAOCULAR",
"StartMarketingDate": "19970106",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "980",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19970107",
"SamplePackage": "N"
},
{
"NDCCode": "50383-042-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-042-24) > 240 mL in 1 BOTTLE",
"NDC11Code": "50383-0042-24",
"ProductNDC": "50383-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone",
"NonProprietaryName": "Prednisolone",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20030227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040401",
"LabelerName": "Akorn",
"SubstanceName": "PREDNISOLONE",
"StrengthNumber": "15",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20030227",
"SamplePackage": "N",
"IndicationAndUsage": "PREDNISOLONE Oral Solution is indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). : 1 Congenital adrenal hyperplasia, 2 Nonsuppurative thyroiditis, 3 Hypercalcemia associated with cancer.",
"Description": "Prednisolone Oral Solution contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water, soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol, slightly soluble in chloroform. The chemical name for Prednisolone is Pregna-1,4 -diene -3, 20 - dione, 11, 17, 21- trihydroxy-,(11β). Its molecular weight is 360.45. The molecular formula is C21H28O5 and the structural formula is. Prednisolone Oral Solution contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5%, citric acid, edetate disodium, glycerin, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40."
},
{
"NDCCode": "50383-042-48",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-042-48) > 480 mL in 1 BOTTLE",
"NDC11Code": "50383-0042-48",
"ProductNDC": "50383-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone",
"NonProprietaryName": "Prednisolone",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20030227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040401",
"LabelerName": "Akorn",
"SubstanceName": "PREDNISOLONE",
"StrengthNumber": "15",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20030227",
"SamplePackage": "N",
"IndicationAndUsage": "PREDNISOLONE Oral Solution is indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). : 1 Congenital adrenal hyperplasia, 2 Nonsuppurative thyroiditis, 3 Hypercalcemia associated with cancer.",
"Description": "Prednisolone Oral Solution contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water, soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol, slightly soluble in chloroform. The chemical name for Prednisolone is Pregna-1,4 -diene -3, 20 - dione, 11, 17, 21- trihydroxy-,(11β). Its molecular weight is 360.45. The molecular formula is C21H28O5 and the structural formula is. Prednisolone Oral Solution contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5%, citric acid, edetate disodium, glycerin, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40."
},
{
"NDCCode": "50383-241-16",
"PackageDescription": "473 mL in 1 BOTTLE (50383-241-16) ",
"NDC11Code": "50383-0241-16",
"ProductNDC": "50383-241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20120228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090601",
"LabelerName": "Akorn",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120228",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam Oral Solution is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, ammonium glycyrrhizinate, citric acid anhydrous, glycerin, maltitol solution, methylparaben, propylparaben, purified water, sodium citrate dihydrate and natural and artificial grape flavor."
},
{
"NDCCode": "50383-265-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (50383-265-02) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50383-0265-02",
"ProductNDC": "50383-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loteprednol Etabonate",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190418",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207609",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190418",
"SamplePackage": "N"
},
{
"NDCCode": "50383-266-25",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-266-25) > 25 mL in 1 BOTTLE",
"NDC11Code": "50383-0266-25",
"ProductNDC": "50383-266",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074222",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".4625",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate topical solution 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula:. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.5 mg/g in a base of carbomer 974P, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide."
},
{
"NDCCode": "50383-266-50",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-266-50) > 50 mL in 1 BOTTLE",
"NDC11Code": "50383-0266-50",
"ProductNDC": "50383-266",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074222",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".4625",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate topical solution 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula:. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.5 mg/g in a base of carbomer 974P, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide."
},
{
"NDCCode": "50383-267-15",
"PackageDescription": "1 TUBE in 1 CARTON (50383-267-15) > 15 g in 1 TUBE",
"NDC11Code": "50383-0267-15",
"ProductNDC": "50383-267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074220",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "50383-267-30",
"PackageDescription": "1 TUBE in 1 CARTON (50383-267-30) > 30 g in 1 TUBE",
"NDC11Code": "50383-0267-30",
"ProductNDC": "50383-267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074220",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "50383-267-45",
"PackageDescription": "1 TUBE in 1 CARTON (50383-267-45) > 45 g in 1 TUBE",
"NDC11Code": "50383-0267-45",
"ProductNDC": "50383-267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074220",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "50383-267-60",
"PackageDescription": "1 TUBE in 1 CARTON (50383-267-60) > 60 g in 1 TUBE",
"NDC11Code": "50383-0267-60",
"ProductNDC": "50383-267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074220",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "50383-268-15",
"PackageDescription": "1 TUBE in 1 CARTON (50383-268-15) > 15 g in 1 TUBE",
"NDC11Code": "50383-0268-15",
"ProductNDC": "50383-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074221",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "50383-268-30",
"PackageDescription": "1 TUBE in 1 CARTON (50383-268-30) > 30 g in 1 TUBE",
"NDC11Code": "50383-0268-30",
"ProductNDC": "50383-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074221",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "50383-268-45",
"PackageDescription": "1 TUBE in 1 CARTON (50383-268-45) > 45 g in 1 TUBE",
"NDC11Code": "50383-0268-45",
"ProductNDC": "50383-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074221",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "50383-268-60",
"PackageDescription": "1 TUBE in 1 CARTON (50383-268-60) > 60 g in 1 TUBE",
"NDC11Code": "50383-0268-60",
"ProductNDC": "50383-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074221",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "50383-269-15",
"PackageDescription": "1 TUBE in 1 CARTON (50383-269-15) > 15 g in 1 TUBE",
"NDC11Code": "50383-0269-15",
"ProductNDC": "50383-269",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076141",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate gel 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/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.",
"Description": "Clobetasol Propionate Gel, 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate gel contains clobetasol propionate 0.5 mg/g in a gel base composed of carbomer 974P, propylene glycol, purified water, and sodium hydroxide."
},
{
"NDCCode": "50383-269-30",
"PackageDescription": "1 TUBE in 1 CARTON (50383-269-30) > 30 g in 1 TUBE",
"NDC11Code": "50383-0269-30",
"ProductNDC": "50383-269",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076141",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate gel 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/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.",
"Description": "Clobetasol Propionate Gel, 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate gel contains clobetasol propionate 0.5 mg/g in a gel base composed of carbomer 974P, propylene glycol, purified water, and sodium hydroxide."
},
{
"NDCCode": "50383-269-60",
"PackageDescription": "1 TUBE in 1 CARTON (50383-269-60) > 60 g in 1 TUBE",
"NDC11Code": "50383-0269-60",
"ProductNDC": "50383-269",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076141",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100607",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate gel 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/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.",
"Description": "Clobetasol Propionate Gel, 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate gel contains clobetasol propionate 0.5 mg/g in a gel base composed of carbomer 974P, propylene glycol, purified water, and sodium hydroxide."
},
{
"NDCCode": "50383-772-15",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-772-15) > 15 mL in 1 BOTTLE",
"NDC11Code": "50383-0772-15",
"ProductNDC": "50383-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anestacon",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20011105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080429",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lidocaine hydrochloride jelly USP, 2% (Anestacon®) is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).",
"Description": "Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) is a sterile aqueous product that contains a local anesthetic agent and is administered topically. (See INDICATIONS AND USAGE for specific uses.). Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) contains lidocaine HCl which is chemically designated as acetamide, 2- (diethyl-amino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) also contains hydroxypropyl methylcellulose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use. Composition of Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) 15 mL bottle: Each mL contains 20 mg of lidocaine HCl. The formulation also contains benzalkonium chloride, hydroxypropyl methylcellulose, purified water, sodium chloride, and sodium hydroxide and/or hydrochloric acid to adjust pH to 6.0–7.0."
},
{
"NDCCode": "50383-978-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-978-02) > 59 mL in 1 BOTTLE",
"NDC11Code": "50383-0978-02",
"ProductNDC": "50383-978",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211348",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20181105",
"SamplePackage": "N",
"Description": "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 Clobetasol Propionate Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of carbomer copolymer Type A, hypromellose, mineral oil, PEG-6 isostearate, propylene glycol, purified water, sodium hydroxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50383-859-21</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (50383-859-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-859-20) </PackageDescription>
<NDC11Code>50383-0859-21</NDC11Code>
<ProductNDC>50383-859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203960</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-286-21</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (50383-286-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-286-20) </PackageDescription>
<NDC11Code>50383-0286-21</NDC11Code>
<ProductNDC>50383-286</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091678</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-824-21</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (50383-824-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-824-20) </PackageDescription>
<NDC11Code>50383-0824-21</NDC11Code>
<ProductNDC>50383-824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074650</ApplicationNumber>
<LabelerName>Akorn Operating Company LLC</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>200; 40</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against Pneumocystis jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis jiroveci pneumonia. Traveler’s Diarrhea In Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim oral suspension is a synthetic antibacterial combination product available for oral administration, with each teaspoonful (5 mL) containing 200 mg sulfamethoxazole and 40 mg trimethoprim. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor.</Description>
</NDC>
<NDC>
<NDCCode>50383-859-11</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (50383-859-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-859-10) </PackageDescription>
<NDC11Code>50383-0859-11</NDC11Code>
<ProductNDC>50383-859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203960</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-859-12</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (50383-859-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-859-10) </PackageDescription>
<NDC11Code>50383-0859-12</NDC11Code>
<ProductNDC>50383-859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203960</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-859-22</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (50383-859-22) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-859-20) </PackageDescription>
<NDC11Code>50383-0859-22</NDC11Code>
<ProductNDC>50383-859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203960</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-859-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-859-24) > 240 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0859-24</NDC11Code>
<ProductNDC>50383-859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203960</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).</IndicationAndUsage>
<Description>Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17α-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 µg per mL, solubility in plasma is 24 µg per mL. Its molecular weight is 384.51. The empirical formula is C24H32O4 and the structural formula is represented as follows. megestrol acetate, USP. Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: citric acid, natural and artificial lemon-lime flavor, polyethylene glycol, polysorbate 80, purified water, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>13537-859-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-859-02) > 30 g in 1 TUBE (13537-859-01)</PackageDescription>
<NDC11Code>13537-0859-02</NDC11Code>
<ProductNDC>13537-859</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Instant Perfection 3 En 1 Face Refining Foundation Spf 25</ProprietaryName>
<ProprietaryNameSuffix>Medio 5 - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .036</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-859-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (14783-859-02) > 30 mL in 1 BOTTLE (14783-859-01)</PackageDescription>
<NDC11Code>14783-0859-02</NDC11Code>
<ProductNDC>14783-859</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm</ProprietaryName>
<ProprietaryNameSuffix>Claire 4 - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151123</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.07; .0244</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68084-859-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-859-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-859-11) </PackageDescription>
<NDC11Code>68084-0859-01</NDC11Code>
<ProductNDC>68084-859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078993</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red. Meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>50383-018-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-018-04) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0018-04</NDC11Code>
<ProductNDC>50383-018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eye Wash</ProprietaryName>
<NonProprietaryName>Eye Wash</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>INTRAOCULAR</RouteName>
<StartMarketingDate>19970106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>980</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-042-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-042-24) > 240 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0042-24</NDC11Code>
<ProductNDC>50383-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisolone</ProprietaryName>
<NonProprietaryName>Prednisolone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040401</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>PREDNISOLONE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREDNISOLONE Oral Solution is indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). : 1 Congenital adrenal hyperplasia, 2 Nonsuppurative thyroiditis, 3 Hypercalcemia associated with cancer.</IndicationAndUsage>
<Description>Prednisolone Oral Solution contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water, soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol, slightly soluble in chloroform. The chemical name for Prednisolone is Pregna-1,4 -diene -3, 20 - dione, 11, 17, 21- trihydroxy-,(11β). Its molecular weight is 360.45. The molecular formula is C21H28O5 and the structural formula is. Prednisolone Oral Solution contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5%, citric acid, edetate disodium, glycerin, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40.</Description>
</NDC>
<NDC>
<NDCCode>50383-042-48</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-042-48) > 480 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0042-48</NDC11Code>
<ProductNDC>50383-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisolone</ProprietaryName>
<NonProprietaryName>Prednisolone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040401</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>PREDNISOLONE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREDNISOLONE Oral Solution is indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). : 1 Congenital adrenal hyperplasia, 2 Nonsuppurative thyroiditis, 3 Hypercalcemia associated with cancer.</IndicationAndUsage>
<Description>Prednisolone Oral Solution contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water, soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol, slightly soluble in chloroform. The chemical name for Prednisolone is Pregna-1,4 -diene -3, 20 - dione, 11, 17, 21- trihydroxy-,(11β). Its molecular weight is 360.45. The molecular formula is C21H28O5 and the structural formula is. Prednisolone Oral Solution contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5%, citric acid, edetate disodium, glycerin, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40.</Description>
</NDC>
<NDC>
<NDCCode>50383-241-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (50383-241-16) </PackageDescription>
<NDC11Code>50383-0241-16</NDC11Code>
<ProductNDC>50383-241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090601</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam Oral Solution is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, ammonium glycyrrhizinate, citric acid anhydrous, glycerin, maltitol solution, methylparaben, propylparaben, purified water, sodium citrate dihydrate and natural and artificial grape flavor.</Description>
</NDC>
<NDC>
<NDCCode>50383-265-02</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (50383-265-02) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>50383-0265-02</NDC11Code>
<ProductNDC>50383-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loteprednol Etabonate</ProprietaryName>
<NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190418</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207609</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-266-25</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-266-25) > 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0266-25</NDC11Code>
<ProductNDC>50383-266</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074222</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.4625</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate topical solution 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula:. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.5 mg/g in a base of carbomer 974P, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>50383-266-50</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-266-50) > 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0266-50</NDC11Code>
<ProductNDC>50383-266</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074222</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.4625</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate topical solution 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula:. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.5 mg/g in a base of carbomer 974P, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>50383-267-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-267-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0267-15</NDC11Code>
<ProductNDC>50383-267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074220</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50383-267-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-267-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0267-30</NDC11Code>
<ProductNDC>50383-267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074220</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50383-267-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-267-45) > 45 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0267-45</NDC11Code>
<ProductNDC>50383-267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074220</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50383-267-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-267-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0267-60</NDC11Code>
<ProductNDC>50383-267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074220</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50383-268-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-268-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0268-15</NDC11Code>
<ProductNDC>50383-268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074221</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50383-268-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-268-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0268-30</NDC11Code>
<ProductNDC>50383-268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074221</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50383-268-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-268-45) > 45 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0268-45</NDC11Code>
<ProductNDC>50383-268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074221</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50383-268-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-268-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0268-60</NDC11Code>
<ProductNDC>50383-268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074221</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/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 Cream and Ointment USP, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>50383-269-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-269-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0269-15</NDC11Code>
<ProductNDC>50383-269</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076141</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate gel 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/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.</IndicationAndUsage>
<Description>Clobetasol Propionate Gel, 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate gel contains clobetasol propionate 0.5 mg/g in a gel base composed of carbomer 974P, propylene glycol, purified water, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>50383-269-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-269-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0269-30</NDC11Code>
<ProductNDC>50383-269</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076141</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate gel 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/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.</IndicationAndUsage>
<Description>Clobetasol Propionate Gel, 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate gel contains clobetasol propionate 0.5 mg/g in a gel base composed of carbomer 974P, propylene glycol, purified water, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>50383-269-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-269-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0269-60</NDC11Code>
<ProductNDC>50383-269</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076141</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate gel 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/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.</IndicationAndUsage>
<Description>Clobetasol Propionate Gel, 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate gel contains clobetasol propionate 0.5 mg/g in a gel base composed of carbomer 974P, propylene glycol, purified water, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>50383-772-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-772-15) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0772-15</NDC11Code>
<ProductNDC>50383-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anestacon</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20011105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080429</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lidocaine hydrochloride jelly USP, 2% (Anestacon®) is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) is a sterile aqueous product that contains a local anesthetic agent and is administered topically. (See INDICATIONS AND USAGE for specific uses.). Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) contains lidocaine HCl which is chemically designated as acetamide, 2- (diethyl-amino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) also contains hydroxypropyl methylcellulose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use. Composition of Lidocaine Hydrochloride Jelly USP, 2% (Anestacon®) 15 mL bottle: Each mL contains 20 mg of lidocaine HCl. The formulation also contains benzalkonium chloride, hydroxypropyl methylcellulose, purified water, sodium chloride, and sodium hydroxide and/or hydrochloric acid to adjust pH to 6.0–7.0.</Description>
</NDC>
<NDC>
<NDCCode>50383-978-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-978-02) > 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0978-02</NDC11Code>
<ProductNDC>50383-978</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211348</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>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 Clobetasol Propionate Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of carbomer copolymer Type A, hypromellose, mineral oil, PEG-6 isostearate, propylene glycol, purified water, sodium hydroxide.</Description>
</NDC>
</NDCList>