{
"NDC": [
{
"NDCCode": "0173-0817-28",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0817-28) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00173-0817-28",
"ProductNDC": "0173-0817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamictal",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "KIT",
"StartMarketingDate": "20030929",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020241",
"LabelerName": "GlaxoSmithKline LLC",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030929",
"SamplePackage": "N",
"IndicationAndUsage": "LAMICTAL is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "LAMICTAL (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. LAMICTAL tablets are supplied for oral administration as 25-mg (white), 100-mg (peach), 150-mg (cream), and 200-mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycolate; FD&C Yellow No. 6 Lake (100-mg tablet only); ferric oxide, yellow (150-mg tablet only); and FD&C Blue No. 2 Lake (200-mg tablet only). LAMICTAL tablets for oral suspension are supplied for oral administration. The tablets contain 2 mg (white), 5 mg (white), or 25 mg (white) of lamotrigine and the following inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate. The tablets for oral suspension meet Organic Impurities Procedure 2 as published in the current USP monograph for Lamotrigine Tablets for Oral Suspension. LAMICTAL ODT orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine and the following inactive ingredients: artificial cherry flavor, crospovidone, ethylcellulose, magnesium stearate, mannitol, polyethylene, and sucralose. LAMICTAL ODT orally disintegrating tablets are formulated using technologies (Microcaps and AdvaTab) designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile. Tablet characteristics including flavor, mouth-feel, after-taste, and ease of use were rated as favorable in a study in 108 healthy volunteers."
},
{
"NDCCode": "56062-817-28",
"PackageDescription": "1 TUBE in 1 CARTON (56062-817-28) / 28 g in 1 TUBE",
"NDC11Code": "56062-0817-28",
"ProductNDC": "56062-817",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Publix Athletic Foot",
"NonProprietaryName": "Clotrimazole 1%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240810",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "PUBLIX SUPER MARKETS, INC.",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240810",
"SamplePackage": "N",
"IndicationAndUsage": "Cures most athlete's foot, jock itch and ringworm. Relieves the itching, burning, scaling, chafing and discomfort associated with these conditions."
},
{
"NDCCode": "71335-0817-3",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (71335-0817-3) ",
"NDC11Code": "71335-0817-03",
"ProductNDC": "71335-0817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207662",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220209",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. 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 one 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. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1 hydroxy-1-methylethyl)-2-propyl-1-[ p-( o- 1H-tetrazol-5-ylphenyl)benzyl]imidazole-5 carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, purified talc, titanium dioxide, and (5 mg only) iron oxide yellow."
},
{
"NDCCode": "0173-0520-00",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0520-00) > 28 POWDER, METERED in 1 INHALER",
"NDC11Code": "00173-0520-00",
"ProductNDC": "0173-0520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Serevent",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Salmeterol Xinafoate",
"DosageFormName": "POWDER, METERED",
"RouteName": "ORAL; RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971201",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020692",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "SALMETEROL XINAFOATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971201",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "0173-0600-01",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0600-01) > 28 POWDER, METERED in 1 INHALER",
"NDC11Code": "00173-0600-01",
"ProductNDC": "0173-0600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flovent",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20070508",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020833",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-01-01"
},
{
"NDCCode": "0173-0601-00",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0601-00) > 28 POWDER, METERED in 1 INHALER",
"NDC11Code": "00173-0601-00",
"ProductNDC": "0173-0601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flovent",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20081013",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020833",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20081013",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "0173-0601-01",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0601-01) > 28 POWDER, METERED in 1 INHALER",
"NDC11Code": "00173-0601-01",
"ProductNDC": "0173-0601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flovent",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20081013",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020833",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0173-0602-00",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0602-00) > 28 POWDER, METERED in 1 INHALER",
"NDC11Code": "00173-0602-00",
"ProductNDC": "0173-0602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flovent",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20081013",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020833",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20081013",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "0173-0602-01",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0602-01) > 28 POWDER, METERED in 1 INHALER",
"NDC11Code": "00173-0602-01",
"ProductNDC": "0173-0602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flovent",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20081013",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020833",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "0173-0847-61",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0173-0847-61)",
"NDC11Code": "00173-0847-61",
"ProductNDC": "0173-0847",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tafinlar",
"NonProprietaryName": "Dabrafenib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202806",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "DABRAFENIB MESYLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporter 1 Inhibitors [MoA],Organic Anion Transporter 3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "50090-0173-2",
"PackageDescription": "28 TABLET in 1 BOTTLE (50090-0173-2) ",
"NDC11Code": "50090-0173-02",
"ProductNDC": "50090-0173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040489",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "67046-173-28",
"PackageDescription": "28 TABLET, FILM COATED in 1 BLISTER PACK (67046-173-28)",
"NDC11Code": "67046-0173-28",
"ProductNDC": "67046-173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram Oxalate",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170925",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021323",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-02-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "71335-0173-3",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (71335-0173-3) ",
"NDC11Code": "71335-0173-03",
"ProductNDC": "71335-0173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141226",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202446",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150921",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum."
},
{
"NDCCode": "51079-817-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-817-20) / 1 CAPSULE in 1 BLISTER PACK (51079-817-01) ",
"NDC11Code": "51079-0817-20",
"ProductNDC": "51079-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090596",
"LabelerName": "MylanInstitutional Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101115",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogenic liver transplants in combination with other immunosuppressants. ( 1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black 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. Meets USP Dissolution Test 5."
},
{
"NDCCode": "52817-817-01",
"PackageDescription": "1 TUBE in 1 CARTON (52817-817-01) / 28.4 g in 1 TUBE",
"NDC11Code": "52817-0817-01",
"ProductNDC": "52817-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate Pramoxine Hcl",
"NonProprietaryName": "Hydrocortisone Acetate, Pramoxine Hcl",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201119",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TRUPHARMA, LLC",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "2.5; 1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201119",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Creamis a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing cetosteryl alcohol, glycerin, isopropyl myristate, poloxamer 407, polyoxyl 40 stearate, potassium sorbate, propylene glycol, purified water, sorbic acid, stearic acid and white petrolatum. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredients are presented below."
},
{
"NDCCode": "53808-0817-1",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (53808-0817-1)",
"NDC11Code": "53808-0817-01",
"ProductNDC": "53808-0817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiothixene",
"NonProprietaryName": "Thiothixene",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071093",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "THIOTHIXENE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.",
"Description": "Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4-methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide. It may be represented by the following structural formula. The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide functional group is bonded to the thioxanthene nucleus. Each capsule contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch and sodium lauryl sulfate. Each of the empty gelatin capsules contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin and titanium dioxide. In addition, the 1 mg empty gelatin capsules contain D&C Red No. 28 and the 2 mg empty gelatin capsules contain D&C Yellow No. 10. The imprinting ink contains the following: 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."
},
{
"NDCCode": "59088-817-01",
"PackageDescription": "1 TUBE in 1 KIT (59088-817-01) / 100 g in 1 TUBE (59088-817-07) ",
"NDC11Code": "59088-0817-01",
"ProductNDC": "59088-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"ProprietaryNameSuffix": "With Aloe",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "GEL",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "28; 5.5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%."
},
{
"NDCCode": "59088-817-07",
"PackageDescription": "100 g in 1 TUBE (59088-817-07) ",
"NDC11Code": "59088-0817-07",
"ProductNDC": "59088-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"ProprietaryNameSuffix": "With Aloe",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "GEL",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "28; 5.5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%."
},
{
"NDCCode": "71205-817-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (71205-817-14) ",
"NDC11Code": "71205-0817-14",
"ProductNDC": "71205-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2023-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230627",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "71205-817-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (71205-817-20) ",
"NDC11Code": "71205-0817-20",
"ProductNDC": "71205-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2023-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230627",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "71205-817-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (71205-817-21) ",
"NDC11Code": "71205-0817-21",
"ProductNDC": "71205-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2023-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230627",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "71205-817-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (71205-817-30) ",
"NDC11Code": "71205-0817-30",
"ProductNDC": "71205-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2023-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230627",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "71205-817-40",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (71205-817-40) ",
"NDC11Code": "71205-0817-40",
"ProductNDC": "71205-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2023-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230627",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "71205-817-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-817-60) ",
"NDC11Code": "71205-0817-60",
"ProductNDC": "71205-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2023-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230627",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "71205-817-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71205-817-90) ",
"NDC11Code": "71205-0817-90",
"ProductNDC": "71205-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2023-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230627",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0173-0377-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (0173-0377-10) > 17 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00173-0377-10",
"ProductNDC": "0173-0377",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fortaz",
"NonProprietaryName": "Ceftazidime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20041129",
"EndMarketingDate": "20140427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050578",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CEFTAZIDIME SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-04-28"
},
{
"NDCCode": "0173-0378-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (0173-0378-10) > 26 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00173-0378-10",
"ProductNDC": "0173-0378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fortaz",
"NonProprietaryName": "Ceftazidime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20041213",
"EndMarketingDate": "20140420",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050578",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CEFTAZIDIME SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-04-28"
},
{
"NDCCode": "0173-0425-00",
"PackageDescription": "24 CONTAINER in 1 CARTON (0173-0425-00) > 50 mL in 1 CONTAINER",
"NDC11Code": "00173-0425-00",
"ProductNDC": "0173-0425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zinacef",
"NonProprietaryName": "Cefuroxime",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19890501",
"EndMarketingDate": "20140521",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050643",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CEFUROXIME SODIUM",
"StrengthNumber": "1.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-05-28"
},
{
"NDCCode": "0173-0602-02",
"PackageDescription": "1 INHALER in 1 CARTON (0173-0602-02) / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "00173-0602-02",
"ProductNDC": "0173-0602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flovent",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20081013",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020833",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20081013",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "FLOVENT DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Important Limitation of Use. FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm.",
"Description": "FLOVENT DISKUS inhalation powder is a dry powder inhaler for oral inhalation. The active component of FLOVENT DISKUS 50 mcg, FLOVENT DISKUS 100 mcg, and FLOVENT DISKUS 250 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. FLOVENT DISKUS is an orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (50, 100, or 250 mcg) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, FLOVENT DISKUS delivers 46, 94, and 229 mcg of fluticasone propionate from FLOVENT DISKUS 50 mcg, FLOVENT DISKUS 100 mcg, and FLOVENT DISKUS 250 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). In children with asthma aged 4 and 8 years, mean PIF through FLOVENT DISKUS was 70 and 104 L/min, respectively (range: 48 to 123 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0179-0173-80",
"PackageDescription": "10 mL in 1 CUP, UNIT-DOSE (0179-0173-80)",
"NDC11Code": "00179-0173-80",
"ProductNDC": "0179-0173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040169",
"LabelerName": "KAISER FOUNDATION HOSPITALS",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0173-0817-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0817-28) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00173-0817-28</NDC11Code>
<ProductNDC>0173-0817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamictal</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20030929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020241</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LAMICTAL is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>LAMICTAL (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. LAMICTAL tablets are supplied for oral administration as 25-mg (white), 100-mg (peach), 150-mg (cream), and 200-mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycolate; FD&C Yellow No. 6 Lake (100-mg tablet only); ferric oxide, yellow (150-mg tablet only); and FD&C Blue No. 2 Lake (200-mg tablet only). LAMICTAL tablets for oral suspension are supplied for oral administration. The tablets contain 2 mg (white), 5 mg (white), or 25 mg (white) of lamotrigine and the following inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate. The tablets for oral suspension meet Organic Impurities Procedure 2 as published in the current USP monograph for Lamotrigine Tablets for Oral Suspension. LAMICTAL ODT orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine and the following inactive ingredients: artificial cherry flavor, crospovidone, ethylcellulose, magnesium stearate, mannitol, polyethylene, and sucralose. LAMICTAL ODT orally disintegrating tablets are formulated using technologies (Microcaps and AdvaTab) designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile. Tablet characteristics including flavor, mouth-feel, after-taste, and ease of use were rated as favorable in a study in 108 healthy volunteers.</Description>
</NDC>
<NDC>
<NDCCode>56062-817-28</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (56062-817-28) / 28 g in 1 TUBE</PackageDescription>
<NDC11Code>56062-0817-28</NDC11Code>
<ProductNDC>56062-817</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Publix Athletic Foot</ProprietaryName>
<NonProprietaryName>Clotrimazole 1%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>PUBLIX SUPER MARKETS, INC.</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cures most athlete's foot, jock itch and ringworm. Relieves the itching, burning, scaling, chafing and discomfort associated with these conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-0817-3</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (71335-0817-3) </PackageDescription>
<NDC11Code>71335-0817-03</NDC11Code>
<ProductNDC>71335-0817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207662</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. 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 one 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. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1 hydroxy-1-methylethyl)-2-propyl-1-[ p-( o- 1H-tetrazol-5-ylphenyl)benzyl]imidazole-5 carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, purified talc, titanium dioxide, and (5 mg only) iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>0173-0520-00</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0520-00) > 28 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00173-0520-00</NDC11Code>
<ProductNDC>0173-0520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Serevent</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Salmeterol Xinafoate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971201</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020692</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971201</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0173-0600-01</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0600-01) > 28 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00173-0600-01</NDC11Code>
<ProductNDC>0173-0600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flovent</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20070508</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020833</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>0173-0601-00</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0601-00) > 28 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00173-0601-00</NDC11Code>
<ProductNDC>0173-0601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flovent</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20081013</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020833</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081013</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0173-0601-01</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0601-01) > 28 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00173-0601-01</NDC11Code>
<ProductNDC>0173-0601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flovent</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20081013</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020833</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0173-0602-00</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0602-00) > 28 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00173-0602-00</NDC11Code>
<ProductNDC>0173-0602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flovent</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20081013</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020833</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081013</StartMarketingDatePackage>
<EndMarketingDatePackage>20211130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0173-0602-01</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0602-01) > 28 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00173-0602-01</NDC11Code>
<ProductNDC>0173-0602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flovent</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20081013</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020833</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>0173-0847-61</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0173-0847-61)</PackageDescription>
<NDC11Code>00173-0847-61</NDC11Code>
<ProductNDC>0173-0847</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tafinlar</ProprietaryName>
<NonProprietaryName>Dabrafenib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202806</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>DABRAFENIB MESYLATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporter 1 Inhibitors [MoA],Organic Anion Transporter 3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>50090-0173-2</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (50090-0173-2) </PackageDescription>
<NDC11Code>50090-0173-02</NDC11Code>
<ProductNDC>50090-0173</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040489</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67046-173-28</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BLISTER PACK (67046-173-28)</PackageDescription>
<NDC11Code>67046-0173-28</NDC11Code>
<ProductNDC>67046-173</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram Oxalate</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170925</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021323</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-02-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71335-0173-3</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (71335-0173-3) </PackageDescription>
<NDC11Code>71335-0173-03</NDC11Code>
<ProductNDC>71335-0173</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141226</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202446</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150921</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>51079-817-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-817-20) / 1 CAPSULE in 1 BLISTER PACK (51079-817-01) </PackageDescription>
<NDC11Code>51079-0817-20</NDC11Code>
<ProductNDC>51079-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090596</ApplicationNumber>
<LabelerName>MylanInstitutional Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogenic liver transplants in combination with other immunosuppressants. ( 1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black 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. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>52817-817-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52817-817-01) / 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>52817-0817-01</NDC11Code>
<ProductNDC>52817-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Acetate Pramoxine Hcl</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate, Pramoxine Hcl</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201119</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TRUPHARMA, LLC</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Creamis a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing cetosteryl alcohol, glycerin, isopropyl myristate, poloxamer 407, polyoxyl 40 stearate, potassium sorbate, propylene glycol, purified water, sorbic acid, stearic acid and white petrolatum. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredients are presented below.</Description>
</NDC>
<NDC>
<NDCCode>53808-0817-1</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (53808-0817-1)</PackageDescription>
<NDC11Code>53808-0817-01</NDC11Code>
<ProductNDC>53808-0817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiothixene</ProprietaryName>
<NonProprietaryName>Thiothixene</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071093</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>THIOTHIXENE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4-methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide. It may be represented by the following structural formula. The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide functional group is bonded to the thioxanthene nucleus. Each capsule contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch and sodium lauryl sulfate. Each of the empty gelatin capsules contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin and titanium dioxide. In addition, the 1 mg empty gelatin capsules contain D&C Red No. 28 and the 2 mg empty gelatin capsules contain D&C Yellow No. 10. The imprinting ink contains the following: 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.</Description>
</NDC>
<NDC>
<NDCCode>59088-817-01</NDCCode>
<PackageDescription>1 TUBE in 1 KIT (59088-817-01) / 100 g in 1 TUBE (59088-817-07) </PackageDescription>
<NDC11Code>59088-0817-01</NDC11Code>
<ProductNDC>59088-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<ProprietaryNameSuffix>With Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>28; 5.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%.</Description>
</NDC>
<NDC>
<NDCCode>59088-817-07</NDCCode>
<PackageDescription>100 g in 1 TUBE (59088-817-07) </PackageDescription>
<NDC11Code>59088-0817-07</NDC11Code>
<ProductNDC>59088-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<ProprietaryNameSuffix>With Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>28; 5.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%.</Description>
</NDC>
<NDC>
<NDCCode>71205-817-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (71205-817-14) </PackageDescription>
<NDC11Code>71205-0817-14</NDC11Code>
<ProductNDC>71205-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71205-817-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (71205-817-20) </PackageDescription>
<NDC11Code>71205-0817-20</NDC11Code>
<ProductNDC>71205-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71205-817-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (71205-817-21) </PackageDescription>
<NDC11Code>71205-0817-21</NDC11Code>
<ProductNDC>71205-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71205-817-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (71205-817-30) </PackageDescription>
<NDC11Code>71205-0817-30</NDC11Code>
<ProductNDC>71205-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71205-817-40</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (71205-817-40) </PackageDescription>
<NDC11Code>71205-0817-40</NDC11Code>
<ProductNDC>71205-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71205-817-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-817-60) </PackageDescription>
<NDC11Code>71205-0817-60</NDC11Code>
<ProductNDC>71205-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71205-817-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71205-817-90) </PackageDescription>
<NDC11Code>71205-0817-90</NDC11Code>
<ProductNDC>71205-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0173-0377-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (0173-0377-10) > 17 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00173-0377-10</NDC11Code>
<ProductNDC>0173-0377</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fortaz</ProprietaryName>
<NonProprietaryName>Ceftazidime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20041129</StartMarketingDate>
<EndMarketingDate>20140427</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050578</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CEFTAZIDIME SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>0173-0378-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (0173-0378-10) > 26 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00173-0378-10</NDC11Code>
<ProductNDC>0173-0378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fortaz</ProprietaryName>
<NonProprietaryName>Ceftazidime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20041213</StartMarketingDate>
<EndMarketingDate>20140420</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050578</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CEFTAZIDIME SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>0173-0425-00</NDCCode>
<PackageDescription>24 CONTAINER in 1 CARTON (0173-0425-00) > 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00173-0425-00</NDC11Code>
<ProductNDC>0173-0425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zinacef</ProprietaryName>
<NonProprietaryName>Cefuroxime</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19890501</StartMarketingDate>
<EndMarketingDate>20140521</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050643</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CEFUROXIME SODIUM</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-05-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>0173-0602-02</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0173-0602-02) / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>00173-0602-02</NDC11Code>
<ProductNDC>0173-0602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flovent</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20081013</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020833</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20081013</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FLOVENT DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Important Limitation of Use. FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>FLOVENT DISKUS inhalation powder is a dry powder inhaler for oral inhalation. The active component of FLOVENT DISKUS 50 mcg, FLOVENT DISKUS 100 mcg, and FLOVENT DISKUS 250 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. FLOVENT DISKUS is an orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (50, 100, or 250 mcg) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, FLOVENT DISKUS delivers 46, 94, and 229 mcg of fluticasone propionate from FLOVENT DISKUS 50 mcg, FLOVENT DISKUS 100 mcg, and FLOVENT DISKUS 250 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). In children with asthma aged 4 and 8 years, mean PIF through FLOVENT DISKUS was 70 and 104 L/min, respectively (range: 48 to 123 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0179-0173-80</NDCCode>
<PackageDescription>10 mL in 1 CUP, UNIT-DOSE (0179-0173-80)</PackageDescription>
<NDC11Code>00179-0173-80</NDC11Code>
<ProductNDC>0179-0173</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040169</ApplicationNumber>
<LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>