{
"NDC": [
{
"NDCCode": "50383-741-20",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (50383-741-20) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "50383-0741-20",
"ProductNDC": "50383-741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074543",
"LabelerName": "Akorn",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.",
"Description": "Albuterol Sulfate Inhalation Solution, 0.5% is a sterile solution that contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGYsection below). Albuterol sulfate has the chemical name α1-[(tert-Butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula. Albuterol sulfate has a molecular weight of 576.71 and the molecular formula (C13H21NO3)2H2SO4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization's recommended name for albuterol base is salbutamol. Albuterol Sulfate Inhalation Solution, 0.5% is in concentrated form. Dilute the appropriate volume of the solution (see DOSAGE AND ADMINISTRATION) with sterile normal saline solution to a total volume of 3 mL and administer by nebulization. Each mL Contains: ACTIVE: Albuterol sulfate equivalent to 5 mg of albuterol in an aqueous solution. Sulfuric Acid may be added to adjust pH (3.5-4.2). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. Albuterol sulfate inhalation solution contains no sulfiting agents. It is supplied in 20 mL bottles. Albuterol Sulfate Inhalation Solution is a clear, colorless sterile solution."
},
{
"NDCCode": "33261-741-20",
"PackageDescription": "20 TABLET, EXTENDED RELEASE in 1 BOTTLE (33261-741-20)",
"NDC11Code": "33261-0741-20",
"ProductNDC": "33261-741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078387",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Alprazolam extended-release tablets are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam extended-release tablets conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The longer-term efficacy of alprazolam extended-release tablets has not been systematically evaluated. Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Alprazolam extended-release tablets contain alprazolam which is a tri-azolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-a] [1,4] benzodiazepine. The molecular formula is C17H13CIN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet for oral administration contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam. The inactive ingredients are lactose monohydrate, hypromellose, calcium silicate and magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Blue #2 and D&C Yellow #10. The 1 mg tablet contains D&C Yellow #10. The 2 mg tablet contains FD&C Blue #2."
},
{
"NDCCode": "42385-741-20",
"PackageDescription": "20 kg in 1 DRUM (42385-741-20) ",
"NDC11Code": "42385-0741-20",
"ProductNDC": "42385-741",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tenofovir Disoproxil Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20171019",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "LAURUS LABS LIMITED",
"SubstanceName": "TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-25",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19-OCT-17"
},
{
"NDCCode": "55513-741-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-20) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01) ",
"NDC11Code": "55513-0741-20",
"ProductNDC": "55513-741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Parsabiv",
"NonProprietaryName": "Etelcalcetide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208325",
"LabelerName": "Amgen, Inc",
"SubstanceName": "ETELCALCETIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.",
"Description": "PARSABIV (etelcalcetide) is a synthetic peptide calcium-sensing receptor agonist. Etelcalcetide is a white to off-white powder with a molecular formula of C38H73N21O10S2∙xHCl (4 ≤ x ≤ 5) and a molecular weight of 1047.5 g/mol (monoisotopic; free base). It is soluble in water. The hydrochloride salt of etelcalcetide is described chemically as N-acetyl-D-cysteinyl-S-(L-cysteine disulfide)-D-alanyl-D-arginyl-D-arginyl-D-arginyl-D-alanyl-D-argininamide hydrochloride. PARSABIV (etelcalcetide) injection is supplied in a single-dose vial containing 5 mg/mL of etelcalcetide as a sterile, preservative-free, ready-to-use clear and colorless solution for intravenous injection. Each PARSABIV single-dose vial contains 2.5 mg etelcalcetide (equivalent to 2.88 mg etelcalcetide as hydrochloride salt) or 5 mg etelcalcetide (equivalent to 5.77 mg etelcalcetide as hydrochloride salt) or 10 mg etelcalcetide (equivalent to 11.54 mg etelcalcetide as hydrochloride salt). PARSABIV single-dose vial is formulated with 0.85% (w/v) sodium chloride, 10 mM succinic acid, and adjusted to pH 3.3 with sodium hydroxide and/or hydrochloric acid."
},
{
"NDCCode": "55910-741-20",
"PackageDescription": "1 BOTTLE in 1 BOX (55910-741-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "55910-0741-20",
"ProductNDC": "55910-741",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206568",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180131",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "71205-741-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (71205-741-20) ",
"NDC11Code": "71205-0741-20",
"ProductNDC": "71205-741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208412",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230106",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets USP are indicated in the following conditions.",
"Description": "Each tablet for oral administration contains. Prednisone, USP.................................................. 20 mg. Inactive Ingredients. The tablets contain lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate and magnesium stearate. Prednisone tablets USP contain prednisone USP, which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "50383-001-20",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-001-20) > 60 mL in 1 BOTTLE",
"NDC11Code": "50383-0001-20",
"ProductNDC": "50383-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074731",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19961224",
"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": "50383-859-21",
"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": "50383-859-22",
"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": "69665-828-01",
"PackageDescription": "1 KIT in 1 CARTON (69665-828-01) * 20 in 1 PACKAGE * 30 g in 1 TUBE (50383-667-30) ",
"NDC11Code": "69665-0828-01",
"ProductNDC": "69665-828",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medolor Pak",
"ProprietaryNameSuffix": "Lidocaine And Prilocaine Cream Kit",
"NonProprietaryName": "Lidocaine And Prilocaine",
"DosageFormName": "KIT",
"StartMarketingDate": "20160809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076290",
"LabelerName": "MedArbor LLC",
"Status": "Deprecated",
"LastUpdate": "2019-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"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": "50383-172-90",
"PackageDescription": "9 BLISTER PACK in 1 CARTON (50383-172-90) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "50383-0172-90",
"ProductNDC": "50383-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocarnitine",
"NonProprietaryName": "Levocarnitine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018948",
"LabelerName": "Akorn",
"SubstanceName": "LEVOCARNITINE",
"StrengthNumber": "330",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carnitine Analog [EPC], Carnitine [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20051101",
"SamplePackage": "N",
"IndicationAndUsage": "Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY). In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient. Levocarnitine is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.",
"Description": "Levocarnitine is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. The chemical name of levocarnitine is 3-carboxy-2(R)-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt. Levocarnitine is a white crystalline, hygroscopic powder. It is readily soluble in water, hot alcohol, and insoluble in acetone. The specific rotation of levocarnitine is between -29° and -32°. Its chemical structure is. Empirical Formula: C7H15NO3. Molecular Weight: 161.20. Each Levocarnitine Tablet USP contains 330 mg of levocarnitine and the inactive ingredients magnesium stearate, microcrystalline cellulose and povidone."
},
{
"NDCCode": "50383-232-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-232-05) > 5 mL in 1 BOTTLE",
"NDC11Code": "50383-0232-05",
"ProductNDC": "50383-232",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride",
"NonProprietaryName": "Dorzolamide Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20081028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077846",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20081028",
"SamplePackage": "N"
},
{
"NDCCode": "50383-232-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-232-10) > 10 mL in 1 BOTTLE",
"NDC11Code": "50383-0232-10",
"ProductNDC": "50383-232",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride",
"NonProprietaryName": "Dorzolamide Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20081028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077846",
"LabelerName": "Akorn",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20081028",
"SamplePackage": "N",
"IndicationAndUsage": "Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Dorzolamide Hydrochloride Ophthalmic Solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. The pH of the solution is approximately 5.6, and the osmolarity is 260-330 mOsM. Each mL of Dorzolamide Hydrochloride Ophthalmic Solution 2% contains 20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dehydrate, sodium hydroxide (to adjust pH) and purified water. Benzalkonium chloride 0.0075% is added as a preservative."
},
{
"NDCCode": "50383-233-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (50383-233-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50383-0233-05",
"ProductNDC": "50383-233",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"NonProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20081028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077847",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"StrengthNumber": "20; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20091028",
"SamplePackage": "N"
},
{
"NDCCode": "50383-233-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (50383-233-10) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50383-0233-10",
"ProductNDC": "50383-233",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"NonProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20081028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077847",
"LabelerName": "Akorn",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"StrengthNumber": "20; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20091028",
"SamplePackage": "N",
"IndicationAndUsage": "Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to betablockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].",
"Description": "Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2- sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride has a molecular weight of 360.91. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate is described chemically as: (-)-1-(tert-butylamino)-3-[(4- morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242-323 mOsM. Each mL of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and purified water. Benzalkonium chloride 0.0075% is added as a preservative."
},
{
"NDCCode": "50383-261-61",
"PackageDescription": "4 POUCH in 1 CARTON (50383-261-61) > 15 VIAL, SINGLE-USE in 1 POUCH > .2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50383-0261-61",
"ProductNDC": "50383-261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"NonProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202667",
"LabelerName": "Akorn",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"StrengthNumber": "20; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190201",
"SamplePackage": "N",
"IndicationAndUsage": "Dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride-timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14.1)].",
"Description": "Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride is described chemically as: (4S-trans)-4- (ethylamino)-5,6-dihydro-6-methyl-4H-thieno [2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride has a molecular weight of 360.91. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate is described chemically as: (-)-1-(tert-butylamino)-3- [(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242-323 mOsM. Each mL of Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) does not contain a preservative."
},
{
"NDCCode": "50383-261-91",
"PackageDescription": "12 POUCH in 1 CARTON (50383-261-91) > 15 VIAL, SINGLE-USE in 1 POUCH > .2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50383-0261-91",
"ProductNDC": "50383-261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"NonProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202667",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"StrengthNumber": "20; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190201",
"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."
},
{
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"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
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"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
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"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",
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"ProductNDC": "50383-267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20100607",
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"ApplicationNumber": "ANDA074220",
"LabelerName": "Akorn",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
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"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
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"ProductNdcExcludeFlag": "N",
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"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]",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20100607",
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"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]",
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"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"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."
}
]
}
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<NDCList>
<NDC>
<NDCCode>50383-741-20</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (50383-741-20) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>50383-0741-20</NDC11Code>
<ProductNDC>50383-741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074543</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.</IndicationAndUsage>
<Description>Albuterol Sulfate Inhalation Solution, 0.5% is a sterile solution that contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGYsection below). Albuterol sulfate has the chemical name α1-[(tert-Butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula. Albuterol sulfate has a molecular weight of 576.71 and the molecular formula (C13H21NO3)2H2SO4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization's recommended name for albuterol base is salbutamol. Albuterol Sulfate Inhalation Solution, 0.5% is in concentrated form. Dilute the appropriate volume of the solution (see DOSAGE AND ADMINISTRATION) with sterile normal saline solution to a total volume of 3 mL and administer by nebulization. Each mL Contains: ACTIVE: Albuterol sulfate equivalent to 5 mg of albuterol in an aqueous solution. Sulfuric Acid may be added to adjust pH (3.5-4.2). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. Albuterol sulfate inhalation solution contains no sulfiting agents. It is supplied in 20 mL bottles. Albuterol Sulfate Inhalation Solution is a clear, colorless sterile solution.</Description>
</NDC>
<NDC>
<NDCCode>33261-741-20</NDCCode>
<PackageDescription>20 TABLET, EXTENDED RELEASE in 1 BOTTLE (33261-741-20)</PackageDescription>
<NDC11Code>33261-0741-20</NDC11Code>
<ProductNDC>33261-741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078387</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Alprazolam extended-release tablets are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam extended-release tablets conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The longer-term efficacy of alprazolam extended-release tablets has not been systematically evaluated. Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Alprazolam extended-release tablets contain alprazolam which is a tri-azolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-a] [1,4] benzodiazepine. The molecular formula is C17H13CIN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet for oral administration contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam. The inactive ingredients are lactose monohydrate, hypromellose, calcium silicate and magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Blue #2 and D&C Yellow #10. The 1 mg tablet contains D&C Yellow #10. The 2 mg tablet contains FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>42385-741-20</NDCCode>
<PackageDescription>20 kg in 1 DRUM (42385-741-20) </PackageDescription>
<NDC11Code>42385-0741-20</NDC11Code>
<ProductNDC>42385-741</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20171019</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>LAURUS LABS LIMITED</LabelerName>
<SubstanceName>TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-25</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19-OCT-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>55513-741-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-20) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01) </PackageDescription>
<NDC11Code>55513-0741-20</NDC11Code>
<ProductNDC>55513-741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Parsabiv</ProprietaryName>
<NonProprietaryName>Etelcalcetide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208325</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>ETELCALCETIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.</IndicationAndUsage>
<Description>PARSABIV (etelcalcetide) is a synthetic peptide calcium-sensing receptor agonist. Etelcalcetide is a white to off-white powder with a molecular formula of C38H73N21O10S2∙xHCl (4 ≤ x ≤ 5) and a molecular weight of 1047.5 g/mol (monoisotopic; free base). It is soluble in water. The hydrochloride salt of etelcalcetide is described chemically as N-acetyl-D-cysteinyl-S-(L-cysteine disulfide)-D-alanyl-D-arginyl-D-arginyl-D-arginyl-D-alanyl-D-argininamide hydrochloride. PARSABIV (etelcalcetide) injection is supplied in a single-dose vial containing 5 mg/mL of etelcalcetide as a sterile, preservative-free, ready-to-use clear and colorless solution for intravenous injection. Each PARSABIV single-dose vial contains 2.5 mg etelcalcetide (equivalent to 2.88 mg etelcalcetide as hydrochloride salt) or 5 mg etelcalcetide (equivalent to 5.77 mg etelcalcetide as hydrochloride salt) or 10 mg etelcalcetide (equivalent to 11.54 mg etelcalcetide as hydrochloride salt). PARSABIV single-dose vial is formulated with 0.85% (w/v) sodium chloride, 10 mM succinic acid, and adjusted to pH 3.3 with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>55910-741-20</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (55910-741-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>55910-0741-20</NDC11Code>
<ProductNDC>55910-741</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206568</ApplicationNumber>
<LabelerName>Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-741-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (71205-741-20) </PackageDescription>
<NDC11Code>71205-0741-20</NDC11Code>
<ProductNDC>71205-741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208412</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets USP are indicated in the following conditions.</IndicationAndUsage>
<Description>Each tablet for oral administration contains. Prednisone, USP.................................................. 20 mg. Inactive Ingredients. The tablets contain lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate and magnesium stearate. Prednisone tablets USP contain prednisone USP, which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>50383-001-20</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-001-20) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0001-20</NDC11Code>
<ProductNDC>50383-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074731</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961224</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>50383-859-21</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>50383-859-22</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>69665-828-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69665-828-01) * 20 in 1 PACKAGE * 30 g in 1 TUBE (50383-667-30) </PackageDescription>
<NDC11Code>69665-0828-01</NDC11Code>
<ProductNDC>69665-828</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medolor Pak</ProprietaryName>
<ProprietaryNameSuffix>Lidocaine And Prilocaine Cream Kit</ProprietaryNameSuffix>
<NonProprietaryName>Lidocaine And Prilocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076290</ApplicationNumber>
<LabelerName>MedArbor LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</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>50383-172-90</NDCCode>
<PackageDescription>9 BLISTER PACK in 1 CARTON (50383-172-90) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50383-0172-90</NDC11Code>
<ProductNDC>50383-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levocarnitine</ProprietaryName>
<NonProprietaryName>Levocarnitine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018948</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LEVOCARNITINE</SubstanceName>
<StrengthNumber>330</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carnitine Analog [EPC], Carnitine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY). In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient. Levocarnitine is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.</IndicationAndUsage>
<Description>Levocarnitine is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. The chemical name of levocarnitine is 3-carboxy-2(R)-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt. Levocarnitine is a white crystalline, hygroscopic powder. It is readily soluble in water, hot alcohol, and insoluble in acetone. The specific rotation of levocarnitine is between -29° and -32°. Its chemical structure is. Empirical Formula: C7H15NO3. Molecular Weight: 161.20. Each Levocarnitine Tablet USP contains 330 mg of levocarnitine and the inactive ingredients magnesium stearate, microcrystalline cellulose and povidone.</Description>
</NDC>
<NDC>
<NDCCode>50383-232-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-232-05) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0232-05</NDC11Code>
<ProductNDC>50383-232</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20081028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077846</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-232-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-232-10) > 10 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0232-10</NDC11Code>
<ProductNDC>50383-232</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20081028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077846</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Dorzolamide Hydrochloride Ophthalmic Solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. The pH of the solution is approximately 5.6, and the osmolarity is 260-330 mOsM. Each mL of Dorzolamide Hydrochloride Ophthalmic Solution 2% contains 20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dehydrate, sodium hydroxide (to adjust pH) and purified water. Benzalkonium chloride 0.0075% is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>50383-233-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (50383-233-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>50383-0233-05</NDC11Code>
<ProductNDC>50383-233</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20081028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077847</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>20; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-233-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (50383-233-10) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>50383-0233-10</NDC11Code>
<ProductNDC>50383-233</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20081028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077847</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>20; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to betablockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2- sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride has a molecular weight of 360.91. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate is described chemically as: (-)-1-(tert-butylamino)-3-[(4- morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242-323 mOsM. Each mL of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and purified water. Benzalkonium chloride 0.0075% is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>50383-261-61</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (50383-261-61) > 15 VIAL, SINGLE-USE in 1 POUCH > .2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50383-0261-61</NDC11Code>
<ProductNDC>50383-261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202667</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>20; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride-timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride is described chemically as: (4S-trans)-4- (ethylamino)-5,6-dihydro-6-methyl-4H-thieno [2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride has a molecular weight of 360.91. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate is described chemically as: (-)-1-(tert-butylamino)-3- [(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242-323 mOsM. Each mL of Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) does not contain a preservative.</Description>
</NDC>
<NDC>
<NDCCode>50383-261-91</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (50383-261-91) > 15 VIAL, SINGLE-USE in 1 POUCH > .2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50383-0261-91</NDC11Code>
<ProductNDC>50383-261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202667</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>20; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190201</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>
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<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>
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<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>
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<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>
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<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>
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