{
"NDC": [
{
"NDCCode": "53808-0621-2",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (53808-0621-2)",
"NDC11Code": "53808-0621-02",
"ProductNDC": "53808-0621",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077127",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Nifedipine Extended-release Tablet is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine Extended-release Tablet may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers.",
"Description": "Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3, 5-pyridinedicarboxylic acid, 1, 4-dihydro-2, 6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.33. Nifedipine Extended-release Tablet is formulated as a once-a-day extended-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: black iron oxide; cellulose acetate; colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polyethylene oxide; polysorbate; povidone; propylene glycol; red ferric oxide; sodium chloride; titanium dioxide; triacetin."
},
{
"NDCCode": "15631-0621-2",
"PackageDescription": "50 TABLET in 1 CONTAINER (15631-0621-2)",
"NDC11Code": "15631-0621-02",
"ProductNDC": "15631-0621",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lactuca Virosa",
"NonProprietaryName": "Lactuca Virosa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151224",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "LACTUCA VIROSA",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "37662-0621-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0621-2) ",
"NDC11Code": "37662-0621-02",
"ProductNDC": "37662-0621",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cuprum Nitricum",
"NonProprietaryName": "Cuprum Nitricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220617",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CUPRIC NITRATE HEXAHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220617",
"SamplePackage": "N"
},
{
"NDCCode": "49288-0621-1",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0621-1)",
"NDC11Code": "49288-0621-01",
"ProductNDC": "49288-0621",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aspergillus Repens",
"NonProprietaryName": "Aspergillus Repens",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ASPERGILLUS REPENS",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0621-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0621-2)",
"NDC11Code": "49288-0621-02",
"ProductNDC": "49288-0621",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aspergillus Repens",
"NonProprietaryName": "Aspergillus Repens",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ASPERGILLUS REPENS",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49580-0621-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (49580-0621-2) / 59 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "49580-0621-02",
"ProductNDC": "49580-0621",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infants Pain And Fever",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"EndMarketingDate": "20250617",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "P & L Development, LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180131",
"EndMarketingDatePackage": "20250617",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily reduces fever. temporarily relieves minor aches and pains due to the common coldfluheadachesore throattoothache."
},
{
"NDCCode": "51524-0621-1",
"PackageDescription": "1 BAG in 1 DRUM (51524-0621-1) > 25 kg in 1 BAG (51524-0621-2)",
"NDC11Code": "51524-0621-01",
"ProductNDC": "51524-0621",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sulfacetamide Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120618",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Yangzhou Tianhe Pharmaceutical Co., Ltd.",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "53002-0621-2",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (53002-0621-2) ",
"NDC11Code": "53002-0621-02",
"ProductNDC": "53002-0621",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063083",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride and other antibacterial drugs, clindamycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride, USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin Hydrochloride Capsules, USP contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: anhydrous lactose, magnesium stearate, starch (corn) and talc. The capsule shells contain: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 150 mg capsule shell also contains black iron oxide and yellow iron oxide. The edible imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. The structural formula is represented below. C18H33CIN2O5SHCl M.W. 461.44. The chemical name for clindamycin hydrochloride, USP is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "67995-0621-1",
"PackageDescription": "1 BAG in 1 BOX (67995-0621-1) > 25000 g in 1 BAG (67995-0621-2)",
"NDC11Code": "67995-0621-01",
"ProductNDC": "67995-0621",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sulfacetamide Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120705",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Yicheng Chemical Corp.",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "69968-0621-2",
"PackageDescription": "1 BOTTLE in 1 BLISTER PACK (69968-0621-2) > 40 mL in 1 BOTTLE",
"NDC11Code": "69968-0621-02",
"ProductNDC": "69968-0621",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Ultra Sheer Face Sunscreen Broad Spectrum Spf 70",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191004",
"EndMarketingDate": "20221101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 75; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191004",
"EndMarketingDatePackage": "20221101",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0621-2",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71335-0621-2) ",
"NDC11Code": "71335-0621-02",
"ProductNDC": "71335-0621",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Acetate",
"NonProprietaryName": "Calcium Acetate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201658",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CALCIUM ACETATE",
"StrengthNumber": "667",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20141008",
"SamplePackage": "N"
},
{
"NDCCode": "53808-0616-2",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (53808-0616-2)",
"NDC11Code": "53808-0616-02",
"ProductNDC": "53808-0616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090540",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Clopidogrel tablets, USP are a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome.",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows: Clopidogrel bisulfate USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration are provided as pink colored, round, biconvex, beveled edge, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each film-coated tablet contains crospovidone, hydrogenated castor oil, hydroxypropyl cellulose low substituted, hypromellose 15cP, iron oxide red, lactose monohydrate, mannitol, microcrystalline cellulose, polyethylene glycol 6000, titanium dioxide, and triacetin as inactive ingredients."
},
{
"NDCCode": "53808-0625-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0625-2)",
"NDC11Code": "53808-0625-02",
"ProductNDC": "53808-0625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074550",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid."
},
{
"NDCCode": "53808-0626-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0626-2)",
"NDC11Code": "53808-0626-02",
"ProductNDC": "53808-0626",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate",
"NonProprietaryName": "Isosorbide Dinitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089367",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "ISOSORBIDE DINITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is. The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate is available as 5 mg, 10 mg, and 20 mg tablets for oral administration. Inactive ingredients: lactose (monohydrate), magnesium stearate, microcrystalline cellulose. The 5 mg also contains FD & C Red #40 Aluminum Lake. The 20 mg also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, and FD & C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "53808-0628-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0628-2)",
"NDC11Code": "53808-0628-02",
"ProductNDC": "53808-0628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075382",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
},
{
"NDCCode": "53808-0689-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0689-2)",
"NDC11Code": "53808-0689-02",
"ProductNDC": "53808-0689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078955",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.",
"Description": "hydrochloride(Propranolol is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are. C16H21NO2.HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow No.6 Aluminium Lake and Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C Red No. 30 Lake."
},
{
"NDCCode": "53808-0691-2",
"PackageDescription": "60 CAPSULE in 1 BLISTER PACK (53808-0691-2)",
"NDC11Code": "53808-0691-02",
"ProductNDC": "53808-0691",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078225",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Tamsulosin hydrochloride capsules are an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1) . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).",
"Description": "Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride, USP is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C20H28N2O5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is:. Each tamsulosin hydrochloride capsule intended for oral administration contains tamsulosin hydrochloride 0.4 mg. In addition, each capsule contains the following inactive ingredients: black iron oxide, D&C yellow # 10, FD&C blue # 1, FD&C red # 40, FD&C yellow # 6, gelatin, methacrylic acid copolymer dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, triacetin and yellow iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as a coloring agent."
},
{
"NDCCode": "53808-0692-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0692-2)",
"NDC11Code": "53808-0692-02",
"ProductNDC": "53808-0692",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076063",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Lisinopril Tablets are indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N 2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril Tablets are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive ingredients are as follows. 2.5 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, and Sodium Starch Glycolate. 5 mg, 10 mg, 20 mg and 30 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, Red Iron Oxide, and Sodium Starch Glycolate. 40 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, Sodium Starch Glycolate, and Yellow Iron Oxide."
},
{
"NDCCode": "53808-0693-2",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (53808-0693-2)",
"NDC11Code": "53808-0693-02",
"ProductNDC": "53808-0693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077127",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Nifedipine Extended-release Tablet is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine Extended-release Tablet may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers.",
"Description": "Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3, 5-pyridinedicarboxylic acid, 1, 4-dihydro-2, 6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.33. Nifedipine Extended-release Tablet is formulated as a once-a-day extended-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: black iron oxide; cellulose acetate; colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polyethylene oxide; polysorbate; povidone; propylene glycol; red ferric oxide; sodium chloride; titanium dioxide; triacetin."
},
{
"NDCCode": "53808-0695-2",
"PackageDescription": "60 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK (53808-0695-2)",
"NDC11Code": "53808-0695-02",
"ProductNDC": "53808-0695",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride, USP is formulated as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride. Each diltiazem extended-release capsule, for oral administration, contains the following inactive ingredients. 120 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 180 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C blue #1, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 240 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 300 mg— ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "53808-0699-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0699-2)",
"NDC11Code": "53808-0699-02",
"ProductNDC": "53808-0699",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078556",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC],Cardiac Glycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin converting enzyme inhibitor, but an optimal order for starting these 3 drugs cannot be specified.",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term \"digitalis\" is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence \"glycosides\"). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125-mcg (0.125-mg) or 250-mcg (0.25-mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, corn starch. The 125-mcg (0.125-mg) strength contains FD&C Yellow #5 (tartrazine)."
},
{
"NDCCode": "53808-0806-2",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (53808-0806-2)",
"NDC11Code": "53808-0806-02",
"ProductNDC": "53808-0806",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090494",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Clopidogrel tablets are P2Y12 platelet inhibitors indicated for: 1 Acute coronary syndromeFor patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)] including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel tablets have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1)For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary PCI is unknown. (1.1), 2 Recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. (1.2).",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9.The structural formula is as follows:Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as pink, round, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose, polyethylene glycol and hydrogenated castor oil as inactive ingredients. The pink film coating contains hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide."
},
{
"NDCCode": "53808-0867-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0867-2)",
"NDC11Code": "53808-0867-02",
"ProductNDC": "53808-0867",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075743",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration."
},
{
"NDCCode": "53808-0868-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0868-2)",
"NDC11Code": "53808-0868-02",
"ProductNDC": "53808-0868",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076059",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hypertension: Lisinopril tablets are indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Lisinopril tablets may be administered alone or with other antihypertensive agents. Heart Failure: Lisinopril tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Acute Myocardial Infarction: Lisinopril tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers. In using lisinopril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS). In considering the use of lisinopril, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (See WARNINGS, Anaphylactoid and Possibly Related Reactions).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Each tablet for oral administration contains 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of lisinopril USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (10 mg only), FD&C Yellow #5 Aluminum Lake (20 mg, 30 mg, and 40 mg, only), magnesium stearate, mannitol, pregelatinized starch."
},
{
"NDCCode": "53808-0870-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0870-2)",
"NDC11Code": "53808-0870-02",
"ProductNDC": "53808-0870",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075743",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration."
},
{
"NDCCode": "53808-0871-2",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (53808-0871-2)",
"NDC11Code": "53808-0871-02",
"ProductNDC": "53808-0871",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021282",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "53808-0872-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0872-2)",
"NDC11Code": "53808-0872-02",
"ProductNDC": "53808-0872",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078432",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. Naproxen as naproxen sodium tablets are indicated. For the relief of the signs and symptoms of rheumatoid arthritis. For the relief of the signs and symptoms of osteoarthritis. For the relief of the signs and symptoms of ankylosing spondylitis. For the relief of the signs and symptoms of juvenile arthritis. For relief of the signs and symptoms of tendonitis. For relief of the signs and symptoms of bursitis. For relief of the signs and symptoms of acute gout. For the management of pain. For the management of primary dysmenorrhea.",
"Description": "Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-〈-methyl-2-naphthalene acetic acid, sodium salt. Naproxen sodium has the following structure. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen Sodium Tablets, USP are available as blue tablets containing 275 mg of naproxen sodium and as blue tablets containing 550 mg of naproxen sodium. The inactive ingredients are. croscarmellose sodium, macrogol, magnesium stearate, polyvinly alcohol, povidone, talc, titanium dioxide and FD&C Blue #2."
},
{
"NDCCode": "53808-0873-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0873-2)",
"NDC11Code": "53808-0873-02",
"ProductNDC": "53808-0873",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074625",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Oxybutynin chloride is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).",
"Description": "Each scored Oxybutynin Chloride Tablet contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3∙HCl. The structural formula appears below:. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets also contain anhydrous lactose, calcium stearate, and microcrystalline cellulose. Oxybutynin Chloride Tablets are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic."
},
{
"NDCCode": "53808-0874-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0874-2)",
"NDC11Code": "53808-0874-02",
"ProductNDC": "53808-0874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077751",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Pravastatin sodium tablet is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1) , 2 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2) , 3 Reduce elevated serum TG levels in patients with hypertriglyceridemia. (1.2) , 4 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 5 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).",
"Description": "Pravastatin sodium is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to yellowish white powder or crystalline powder, hygroscopic in nature. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is freely soluble in water and in methanol. Soluble in ethanol. Each pravastatin sodium tablet intended for oral administration contains 10 mg or 20 mg or 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyoxyl 35 castor oil and sodium carbonate anhydrous."
},
{
"NDCCode": "53808-0875-2",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (53808-0875-2)",
"NDC11Code": "53808-0875-02",
"ProductNDC": "53808-0875",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077751",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Pravastatin sodium tablet is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1) , 2 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2) , 3 Reduce elevated serum TG levels in patients with hypertriglyceridemia. (1.2) , 4 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 5 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).",
"Description": "Pravastatin sodium is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to yellowish white powder or crystalline powder, hygroscopic in nature. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is freely soluble in water and in methanol. Soluble in ethanol. Each pravastatin sodium tablet intended for oral administration contains 10 mg or 20 mg or 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyoxyl 35 castor oil and sodium carbonate anhydrous."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>53808-0621-2</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (53808-0621-2)</PackageDescription>
<NDC11Code>53808-0621-02</NDC11Code>
<ProductNDC>53808-0621</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077127</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nifedipine Extended-release Tablet is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine Extended-release Tablet may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers.</IndicationAndUsage>
<Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3, 5-pyridinedicarboxylic acid, 1, 4-dihydro-2, 6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.33. Nifedipine Extended-release Tablet is formulated as a once-a-day extended-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: black iron oxide; cellulose acetate; colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polyethylene oxide; polysorbate; povidone; propylene glycol; red ferric oxide; sodium chloride; titanium dioxide; triacetin.</Description>
</NDC>
<NDC>
<NDCCode>15631-0621-2</NDCCode>
<PackageDescription>50 TABLET in 1 CONTAINER (15631-0621-2)</PackageDescription>
<NDC11Code>15631-0621-02</NDC11Code>
<ProductNDC>15631-0621</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lactuca Virosa</ProprietaryName>
<NonProprietaryName>Lactuca Virosa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>LACTUCA VIROSA</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0621-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-0621-2) </PackageDescription>
<NDC11Code>37662-0621-02</NDC11Code>
<ProductNDC>37662-0621</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cuprum Nitricum</ProprietaryName>
<NonProprietaryName>Cuprum Nitricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220617</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CUPRIC NITRATE HEXAHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49288-0621-1</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0621-1)</PackageDescription>
<NDC11Code>49288-0621-01</NDC11Code>
<ProductNDC>49288-0621</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspergillus Repens</ProprietaryName>
<NonProprietaryName>Aspergillus Repens</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ASPERGILLUS REPENS</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0621-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0621-2)</PackageDescription>
<NDC11Code>49288-0621-02</NDC11Code>
<ProductNDC>49288-0621</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspergillus Repens</ProprietaryName>
<NonProprietaryName>Aspergillus Repens</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ASPERGILLUS REPENS</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49580-0621-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (49580-0621-2) / 59 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>49580-0621-02</NDC11Code>
<ProductNDC>49580-0621</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Infants Pain And Fever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180131</StartMarketingDate>
<EndMarketingDate>20250617</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>P & L Development, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180131</StartMarketingDatePackage>
<EndMarketingDatePackage>20250617</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily reduces fever. temporarily relieves minor aches and pains due to the common coldfluheadachesore throattoothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51524-0621-1</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (51524-0621-1) > 25 kg in 1 BAG (51524-0621-2)</PackageDescription>
<NDC11Code>51524-0621-01</NDC11Code>
<ProductNDC>51524-0621</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120618</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Yangzhou Tianhe Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53002-0621-2</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE (53002-0621-2) </PackageDescription>
<NDC11Code>53002-0621-02</NDC11Code>
<ProductNDC>53002-0621</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063083</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride and other antibacterial drugs, clindamycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride, USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin Hydrochloride Capsules, USP contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: anhydrous lactose, magnesium stearate, starch (corn) and talc. The capsule shells contain: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 150 mg capsule shell also contains black iron oxide and yellow iron oxide. The edible imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. The structural formula is represented below. C18H33CIN2O5SHCl M.W. 461.44. The chemical name for clindamycin hydrochloride, USP is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>67995-0621-1</NDCCode>
<PackageDescription>1 BAG in 1 BOX (67995-0621-1) > 25000 g in 1 BAG (67995-0621-2)</PackageDescription>
<NDC11Code>67995-0621-01</NDC11Code>
<ProductNDC>67995-0621</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120705</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Yicheng Chemical Corp.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69968-0621-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 BLISTER PACK (69968-0621-2) > 40 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69968-0621-02</NDC11Code>
<ProductNDC>69968-0621</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Ultra Sheer Face Sunscreen Broad Spectrum Spf 70</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191004</StartMarketingDate>
<EndMarketingDate>20221101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 75; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191004</StartMarketingDatePackage>
<EndMarketingDatePackage>20221101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-0621-2</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71335-0621-2) </PackageDescription>
<NDC11Code>71335-0621-02</NDC11Code>
<ProductNDC>71335-0621</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Acetate</ProprietaryName>
<NonProprietaryName>Calcium Acetate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201658</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CALCIUM ACETATE</SubstanceName>
<StrengthNumber>667</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53808-0616-2</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BLISTER PACK (53808-0616-2)</PackageDescription>
<NDC11Code>53808-0616-02</NDC11Code>
<ProductNDC>53808-0616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090540</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clopidogrel tablets, USP are a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome.</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows: Clopidogrel bisulfate USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration are provided as pink colored, round, biconvex, beveled edge, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each film-coated tablet contains crospovidone, hydrogenated castor oil, hydroxypropyl cellulose low substituted, hypromellose 15cP, iron oxide red, lactose monohydrate, mannitol, microcrystalline cellulose, polyethylene glycol 6000, titanium dioxide, and triacetin as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>53808-0625-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0625-2)</PackageDescription>
<NDC11Code>53808-0625-02</NDC11Code>
<ProductNDC>53808-0625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074550</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>53808-0626-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0626-2)</PackageDescription>
<NDC11Code>53808-0626-02</NDC11Code>
<ProductNDC>53808-0626</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089367</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is. The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate is available as 5 mg, 10 mg, and 20 mg tablets for oral administration. Inactive ingredients: lactose (monohydrate), magnesium stearate, microcrystalline cellulose. The 5 mg also contains FD & C Red #40 Aluminum Lake. The 20 mg also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, and FD & C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>53808-0628-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0628-2)</PackageDescription>
<NDC11Code>53808-0628-02</NDC11Code>
<ProductNDC>53808-0628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075382</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>53808-0689-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0689-2)</PackageDescription>
<NDC11Code>53808-0689-02</NDC11Code>
<ProductNDC>53808-0689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078955</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>hydrochloride(Propranolol is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are. C16H21NO2.HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow No.6 Aluminium Lake and Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C Red No. 30 Lake.</Description>
</NDC>
<NDC>
<NDCCode>53808-0691-2</NDCCode>
<PackageDescription>60 CAPSULE in 1 BLISTER PACK (53808-0691-2)</PackageDescription>
<NDC11Code>53808-0691-02</NDC11Code>
<ProductNDC>53808-0691</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078225</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tamsulosin hydrochloride capsules are an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1) . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).</IndicationAndUsage>
<Description>Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride, USP is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C20H28N2O5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is:. Each tamsulosin hydrochloride capsule intended for oral administration contains tamsulosin hydrochloride 0.4 mg. In addition, each capsule contains the following inactive ingredients: black iron oxide, D&C yellow # 10, FD&C blue # 1, FD&C red # 40, FD&C yellow # 6, gelatin, methacrylic acid copolymer dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, triacetin and yellow iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as a coloring agent.</Description>
</NDC>
<NDC>
<NDCCode>53808-0692-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0692-2)</PackageDescription>
<NDC11Code>53808-0692-02</NDC11Code>
<ProductNDC>53808-0692</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076063</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lisinopril Tablets are indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N 2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril Tablets are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive ingredients are as follows. 2.5 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, and Sodium Starch Glycolate. 5 mg, 10 mg, 20 mg and 30 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, Red Iron Oxide, and Sodium Starch Glycolate. 40 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, Sodium Starch Glycolate, and Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>53808-0693-2</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (53808-0693-2)</PackageDescription>
<NDC11Code>53808-0693-02</NDC11Code>
<ProductNDC>53808-0693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077127</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nifedipine Extended-release Tablet is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine Extended-release Tablet may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers.</IndicationAndUsage>
<Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3, 5-pyridinedicarboxylic acid, 1, 4-dihydro-2, 6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.33. Nifedipine Extended-release Tablet is formulated as a once-a-day extended-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: black iron oxide; cellulose acetate; colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polyethylene oxide; polysorbate; povidone; propylene glycol; red ferric oxide; sodium chloride; titanium dioxide; triacetin.</Description>
</NDC>
<NDC>
<NDCCode>53808-0695-2</NDCCode>
<PackageDescription>60 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK (53808-0695-2)</PackageDescription>
<NDC11Code>53808-0695-02</NDC11Code>
<ProductNDC>53808-0695</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride, USP is formulated as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride. Each diltiazem extended-release capsule, for oral administration, contains the following inactive ingredients. 120 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 180 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C blue #1, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 240 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 300 mg— ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>53808-0699-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0699-2)</PackageDescription>
<NDC11Code>53808-0699-02</NDC11Code>
<ProductNDC>53808-0699</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078556</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC],Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin converting enzyme inhibitor, but an optimal order for starting these 3 drugs cannot be specified.</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term "digitalis" is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence "glycosides"). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125-mcg (0.125-mg) or 250-mcg (0.25-mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, corn starch. The 125-mcg (0.125-mg) strength contains FD&C Yellow #5 (tartrazine).</Description>
</NDC>
<NDC>
<NDCCode>53808-0806-2</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BLISTER PACK (53808-0806-2)</PackageDescription>
<NDC11Code>53808-0806-02</NDC11Code>
<ProductNDC>53808-0806</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090494</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clopidogrel tablets are P2Y12 platelet inhibitors indicated for: 1 Acute coronary syndromeFor patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)] including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel tablets have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1)For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary PCI is unknown. (1.1), 2 Recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. (1.2).</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9.The structural formula is as follows:Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as pink, round, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose, polyethylene glycol and hydrogenated castor oil as inactive ingredients. The pink film coating contains hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>53808-0867-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0867-2)</PackageDescription>
<NDC11Code>53808-0867-02</NDC11Code>
<ProductNDC>53808-0867</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075743</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>53808-0868-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0868-2)</PackageDescription>
<NDC11Code>53808-0868-02</NDC11Code>
<ProductNDC>53808-0868</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076059</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hypertension: Lisinopril tablets are indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Lisinopril tablets may be administered alone or with other antihypertensive agents. Heart Failure: Lisinopril tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Acute Myocardial Infarction: Lisinopril tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers. In using lisinopril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS). In considering the use of lisinopril, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (See WARNINGS, Anaphylactoid and Possibly Related Reactions).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Each tablet for oral administration contains 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of lisinopril USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (10 mg only), FD&C Yellow #5 Aluminum Lake (20 mg, 30 mg, and 40 mg, only), magnesium stearate, mannitol, pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>53808-0870-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0870-2)</PackageDescription>
<NDC11Code>53808-0870-02</NDC11Code>
<ProductNDC>53808-0870</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075743</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>53808-0871-2</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (53808-0871-2)</PackageDescription>
<NDC11Code>53808-0871-02</NDC11Code>
<ProductNDC>53808-0871</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021282</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53808-0872-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0872-2)</PackageDescription>
<NDC11Code>53808-0872-02</NDC11Code>
<ProductNDC>53808-0872</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078432</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. Naproxen as naproxen sodium tablets are indicated. For the relief of the signs and symptoms of rheumatoid arthritis. For the relief of the signs and symptoms of osteoarthritis. For the relief of the signs and symptoms of ankylosing spondylitis. For the relief of the signs and symptoms of juvenile arthritis. For relief of the signs and symptoms of tendonitis. For relief of the signs and symptoms of bursitis. For relief of the signs and symptoms of acute gout. For the management of pain. For the management of primary dysmenorrhea.</IndicationAndUsage>
<Description>Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-〈-methyl-2-naphthalene acetic acid, sodium salt. Naproxen sodium has the following structure. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen Sodium Tablets, USP are available as blue tablets containing 275 mg of naproxen sodium and as blue tablets containing 550 mg of naproxen sodium. The inactive ingredients are. croscarmellose sodium, macrogol, magnesium stearate, polyvinly alcohol, povidone, talc, titanium dioxide and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>53808-0873-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0873-2)</PackageDescription>
<NDC11Code>53808-0873-02</NDC11Code>
<ProductNDC>53808-0873</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074625</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxybutynin chloride is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).</IndicationAndUsage>
<Description>Each scored Oxybutynin Chloride Tablet contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3∙HCl. The structural formula appears below:. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets also contain anhydrous lactose, calcium stearate, and microcrystalline cellulose. Oxybutynin Chloride Tablets are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic.</Description>
</NDC>
<NDC>
<NDCCode>53808-0874-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0874-2)</PackageDescription>
<NDC11Code>53808-0874-02</NDC11Code>
<ProductNDC>53808-0874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077751</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pravastatin sodium tablet is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1) , 2 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2) , 3 Reduce elevated serum TG levels in patients with hypertriglyceridemia. (1.2) , 4 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 5 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).</IndicationAndUsage>
<Description>Pravastatin sodium is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to yellowish white powder or crystalline powder, hygroscopic in nature. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is freely soluble in water and in methanol. Soluble in ethanol. Each pravastatin sodium tablet intended for oral administration contains 10 mg or 20 mg or 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyoxyl 35 castor oil and sodium carbonate anhydrous.</Description>
</NDC>
<NDC>
<NDCCode>53808-0875-2</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (53808-0875-2)</PackageDescription>
<NDC11Code>53808-0875-02</NDC11Code>
<ProductNDC>53808-0875</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077751</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pravastatin sodium tablet is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1) , 2 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2) , 3 Reduce elevated serum TG levels in patients with hypertriglyceridemia. (1.2) , 4 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 5 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).</IndicationAndUsage>
<Description>Pravastatin sodium is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to yellowish white powder or crystalline powder, hygroscopic in nature. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is freely soluble in water and in methanol. Soluble in ethanol. Each pravastatin sodium tablet intended for oral administration contains 10 mg or 20 mg or 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyoxyl 35 castor oil and sodium carbonate anhydrous.</Description>
</NDC>
</NDCList>