{
"NDC": [
{
"NDCCode": "71205-348-05",
"PackageDescription": "5 PATCH in 1 BOX (71205-348-05) / 1 g in 1 PATCH",
"NDC11Code": "71205-0348-05",
"ProductNDC": "71205-348",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidozen",
"NonProprietaryName": "Lidocaine, Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190916",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LIDOCAINE; MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "40; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210824",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of pain."
},
{
"NDCCode": "71205-348-15",
"PackageDescription": "15 PATCH in 1 BOX (71205-348-15) / 1 g in 1 PATCH",
"NDC11Code": "71205-0348-15",
"ProductNDC": "71205-348",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidozen",
"NonProprietaryName": "Lidocaine, Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190916",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LIDOCAINE; MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "40; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210824",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of pain."
},
{
"NDCCode": "71205-348-30",
"PackageDescription": "30 PATCH in 1 BOX (71205-348-30) / 1 g in 1 PATCH",
"NDC11Code": "71205-0348-30",
"ProductNDC": "71205-348",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidozen",
"NonProprietaryName": "Lidocaine, Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190916",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LIDOCAINE; MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "40; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191101",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of pain."
},
{
"NDCCode": "41520-348-05",
"PackageDescription": "170 g in 1 CAN (41520-348-05) ",
"NDC11Code": "41520-0348-05",
"ProductNDC": "41520-348",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Burn Relief",
"NonProprietaryName": "Lidocaine 0.5%",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170315",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Care One",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": ".5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170315",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves pain and itching due to. sunburn minor burns minor cuts scrapes. insect bites minor skin irritation."
},
{
"NDCCode": "42571-348-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-05) ",
"NDC11Code": "42571-0348-05",
"ProductNDC": "42571-348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibric Acid",
"NonProprietaryName": "Fenofibric Acid",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213450",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "FENOFIBRIC ACID",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibricacid delayed-release capsules are indicated as adjunctive therapy to diet: 1 toreduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL)., 2 toreduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy isnot possible.",
"Description": "Fenofibric acid delayed-release capsules (fenofibric acid) are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5and the molecular weight is 421.91. Choline fenofibrate is freely soluble in methanol, sparingly soluble in ethanol and water, slightly soluble in DMSO and practically insoluble in dichloromethane. The melting point is approximately 210°C. Choline fenofibrate is a white to off white crystalline powder, which is stable under ordinary conditions. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: hypromellose, hydroxypropyl cellulose, methacrylic acid - ethyl acrylate copolymer (1:1) type A , microcrystalline cellulose, povidone K30, silicon dioxide, sodium stearyl fumarate, talc, triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: ferrosoferric oxide, ferric oxide red, gelatin and titanium dioxide. The capsule shell of the 135 mg capsule contains the following inactive ingredients: FD&C blue no.1, FD&C red no.3, FD&C red no. 40, gelatin and titanium dioxide."
},
{
"NDCCode": "42806-348-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-348-05) ",
"NDC11Code": "42806-0348-05",
"ProductNDC": "42806-348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207224",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180529",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1).",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 150 mg and 300 mg white, round, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: colloidal silicon dioxide, copovidone, ethyl cellulose, hydroxypropyl cellulose, glyceryl behenate, methacrylic acid copolymer and silicon dioxide. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test is pending."
},
{
"NDCCode": "49643-348-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-348-05) ",
"NDC11Code": "49643-0348-05",
"ProductNDC": "49643-348",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Winterfat Pollen",
"NonProprietaryName": "Eurotia Lanata",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "KRASCHENINNIKOVIA LANATA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "50419-348-05",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (50419-348-05) / 50 mL in 1 VIAL, GLASS",
"NDC11Code": "50419-0348-05",
"ProductNDC": "50419-348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultravist",
"NonProprietaryName": "Iopromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
"StartMarketingDate": "20220608",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020220",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "IOPROMIDE",
"StrengthNumber": "370",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220608",
"SamplePackage": "N",
"IndicationAndUsage": "ULTRAVIST® Injection is an iodinated contrast agent indicated for.",
"Description": "ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water)."
},
{
"NDCCode": "51991-348-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (51991-348-05) ",
"NDC11Code": "51991-0348-05",
"ProductNDC": "51991-348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204921",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220318",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide tablets are indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1).",
"Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "52959-348-05",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (52959-348-05)",
"NDC11Code": "52959-0348-05",
"ProductNDC": "52959-348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19771121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085966",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"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-5H-dibenzo[a,d] cycloheptene-Δ5, 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 silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn) and titanium dioxide. The 10 mg also includes D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake; 25 mg – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake; 50 mg – FD&C Blue #2 Aluminum Lake and FD&C Red #40 Aluminum Lake; 75 mg – D&C Red #7 Calcium Lake and FD&C Blue #2 Aluminum Lake; 100 mg – D&C Red #30 Aluminum Lake and D&C Yellow #10 Aluminum Lake; 150 mg – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake."
},
{
"NDCCode": "68428-348-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-348-05) ",
"NDC11Code": "68428-0348-05",
"ProductNDC": "68428-348",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cuprum Arsenicosum",
"NonProprietaryName": "Cupric Arsenite",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CUPRIC ARSENITE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "71948-101-05",
"PackageDescription": "5 PATCH in 1 PACKAGE (71948-101-05) > .348 g in 1 PATCH",
"NDC11Code": "71948-0101-05",
"ProductNDC": "71948-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The Black Patch",
"NonProprietaryName": "Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Carbon Innovation, Inc.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "4",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20171230",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains."
},
{
"NDCCode": "84756-348-05",
"PackageDescription": "100 g in 1 BOX (84756-348-05) ",
"NDC11Code": "84756-0348-05",
"ProductNDC": "84756-348",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Intensive Moisturizes Cream",
"NonProprietaryName": "Intensive Moisturizes Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241118",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "71205-002-05",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (71205-002-05) ",
"NDC11Code": "71205-0002-05",
"ProductNDC": "71205-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202801",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180402",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section.",
"Description": "Levofloxacin, USP is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate.Figure 1: The Chemical Structure of Levofloxacin, USPThe molecular formula is C18H20FN3O4 1/2 H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9.Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage FormLevofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg: croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 500 mg: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 750 mg: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.Levofloxacin tablets, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "71205-051-05",
"PackageDescription": "5 POUCH in 1 CARTON (71205-051-05) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "71205-0051-05",
"ProductNDC": "71205-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076749",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
"StrengthNumber": ".5; 3",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240110",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
"Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-Butylamino) methyl]-4-hydroxy- m-xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3 H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see Error! Hyperlink reference not valid.)."
},
{
"NDCCode": "71205-089-05",
"PackageDescription": "5 TABLET in 1 BOTTLE (71205-089-05) ",
"NDC11Code": "71205-0089-05",
"ProductNDC": "71205-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040611",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2019-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180801",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 1. Endocrine Disorders:. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler's syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21H26O5. Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structural formula:. Molecular weight: 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. Each tablet, for oral administration, contains 1 mg of prednisone. Inactive Ingredients: Lactose, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate."
},
{
"NDCCode": "71205-101-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (71205-101-05) > 5 mL in 1 BOTTLE",
"NDC11Code": "71205-0101-05",
"ProductNDC": "71205-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20170705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207444",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180904",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children.",
"Description": "Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin ophthalmic solution USP, 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: Benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is. Molecular Weight = 467.52. Molecular Formula: C18H37N5O9. Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine."
},
{
"NDCCode": "71205-115-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (71205-115-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "71205-0115-05",
"ProductNDC": "71205-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ketotifen Fumarate",
"NonProprietaryName": "Ketotifen Fumarate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077958",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "KETOTIFEN FUMARATE",
"StrengthNumber": ".35",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2019-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180904",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander."
},
{
"NDCCode": "71205-200-05",
"PackageDescription": "5 TABLET in 1 BOTTLE (71205-200-05) ",
"NDC11Code": "71205-0200-05",
"ProductNDC": "71205-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070108",
"EndMarketingDate": "20210930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071141",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190101",
"EndMarketingDatePackage": "20190930",
"SamplePackage": "N"
},
{
"NDCCode": "71205-234-05",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (71205-234-05) ",
"NDC11Code": "71205-0234-05",
"ProductNDC": "71205-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200839",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) Plague in adult and pediatric patients (1.8) Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) Acute Pyelonephritis (1.11) Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) Acute Bacterial Sinusitis (1.14). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).",
"Description": "Levofloxacin USP is a synthetic antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (--(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate.Figure 1: The Chemical Structure of Levofloxacin USP. The molecular formula is C18H20FN3O4½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Levofloxacin USP are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide. , 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides. , 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80."
},
{
"NDCCode": "71205-235-05",
"PackageDescription": "5 TABLET in 1 BOTTLE (71205-235-05) ",
"NDC11Code": "71205-0235-05",
"ProductNDC": "71205-235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078203",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2022-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210226",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose anhydrous, microcrystalline cellulose, polacrilin potassium and magnesium stearate."
},
{
"NDCCode": "71205-239-05",
"PackageDescription": "5 TABLET in 1 BOTTLE (71205-239-05) ",
"NDC11Code": "71205-0239-05",
"ProductNDC": "71205-239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085161",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets, USP are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C21H26O5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone, USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone tablets, USP 20 mg also contain FD&C Yellow No. 6."
},
{
"NDCCode": "71205-296-05",
"PackageDescription": "5 mL in 1 BOTTLE (71205-296-05) ",
"NDC11Code": "71205-0296-05",
"ProductNDC": "71205-296",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20091105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076583",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": "Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.",
"Description": "Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution contains a racemic mixture of R-( + ) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of Ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of Ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH."
},
{
"NDCCode": "71205-300-05",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (71205-300-05) > 5 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "71205-0300-05",
"ProductNDC": "71205-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077568",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2022-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Corneal Ulcers:. Pseudomonas aeruginosa. Serratia marcescens *. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. Streptococcus (Viridans Group) *. Conjunctivitis:. Haemophilus influenzae. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Ciprofloxacin Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin Ophthalmic Solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactives: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm."
},
{
"NDCCode": "71205-302-05",
"PackageDescription": "5 PATCH in 1 POUCH (71205-302-05) > 1 g in 1 PATCH",
"NDC11Code": "71205-0302-05",
"ProductNDC": "71205-302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidozen",
"NonProprietaryName": "Lidocaine Hydrochloride, Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "40; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N"
},
{
"NDCCode": "71205-333-05",
"PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (71205-333-05) ",
"NDC11Code": "71205-0333-05",
"ProductNDC": "71205-333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentamicin Sulfate",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19960405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062196",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "GENTAMICIN SULFATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Gentamicin Sulfate Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.",
"Description": "DESCRIPTION: Gentamicin Sulfate is a water-soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to approximately pH 7 for ophthalmic use. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as white powder and is soluble in water and insoluble in alcohol. The structure is as follows. Established name: Gentamicin Sulfate. Chemical name: 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine. Ingredients: Each mL contains: Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin). Preservative: Benzalkonium Chloride 0.1 mg (0.01%). Inactives: Sodium Chloride, Dried Sodium Phosphate, Tyloxapol, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Purified Water."
},
{
"NDCCode": "71205-334-05",
"PackageDescription": "5 PATCH in 1 POUCH (71205-334-05) / 1 g in 1 PATCH",
"NDC11Code": "71205-0334-05",
"ProductNDC": "71205-334",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menthozen Hydrogel",
"NonProprietaryName": "Menthol, Capsaicin",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM; CAPSAICIN",
"StrengthNumber": "40; .3",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201120",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains."
},
{
"NDCCode": "71205-345-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (71205-345-05) > 5 mL in 1 BOTTLE",
"NDC11Code": "71205-0345-05",
"ProductNDC": "71205-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olopatadine Hydrochloride",
"NonProprietaryName": "Olopatadine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206306",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
"StrengthNumber": "1.11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Olopatadine hydrochloride ophthalmic solution USP, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.",
"Description": "Olopatadine hydrochloride ophthalmic solution USP, 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1 -receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 373.88. The chemical structure is presented below. Chemical Name: 11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e] oxepin-2-acetic acid hydrochloride. Each mL of Olopatadine hydrochloride ophthalmic solution, USP contains:. Active: 1.11 mg olopatadine hydrochloride, USP equivalent to 1 mg olopatadine. Preservative: benzalkonium chloride 0.01%. Inactives: dibasic sodium phosphate; sodium chloride; hydrochloric acid/sodium hydroxide (adjust pH); and water for injection. It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg."
},
{
"NDCCode": "71205-362-05",
"PackageDescription": "5 TABLET in 1 BOTTLE (71205-362-05) ",
"NDC11Code": "71205-0362-05",
"ProductNDC": "71205-362",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085162",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201221",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets, USP are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C21H26O5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 10 mg of prednisone, USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone tablets, USP 20 mg also contain FD&C Yellow No. 6."
},
{
"NDCCode": "71205-403-05",
"PackageDescription": "5 TABLET in 1 BOTTLE, PLASTIC (71205-403-05) ",
"NDC11Code": "71205-0403-05",
"ProductNDC": "71205-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210525",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200319",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>71205-348-05</NDCCode>
<PackageDescription>5 PATCH in 1 BOX (71205-348-05) / 1 g in 1 PATCH</PackageDescription>
<NDC11Code>71205-0348-05</NDC11Code>
<ProductNDC>71205-348</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidozen</ProprietaryName>
<NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190916</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>40; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-348-15</NDCCode>
<PackageDescription>15 PATCH in 1 BOX (71205-348-15) / 1 g in 1 PATCH</PackageDescription>
<NDC11Code>71205-0348-15</NDC11Code>
<ProductNDC>71205-348</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidozen</ProprietaryName>
<NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190916</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>40; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-348-30</NDCCode>
<PackageDescription>30 PATCH in 1 BOX (71205-348-30) / 1 g in 1 PATCH</PackageDescription>
<NDC11Code>71205-0348-30</NDC11Code>
<ProductNDC>71205-348</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidozen</ProprietaryName>
<NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190916</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>40; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41520-348-05</NDCCode>
<PackageDescription>170 g in 1 CAN (41520-348-05) </PackageDescription>
<NDC11Code>41520-0348-05</NDC11Code>
<ProductNDC>41520-348</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Burn Relief</ProprietaryName>
<NonProprietaryName>Lidocaine 0.5%</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Care One</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves pain and itching due to. sunburn minor burns minor cuts scrapes. insect bites minor skin irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42571-348-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-348-05) </PackageDescription>
<NDC11Code>42571-0348-05</NDC11Code>
<ProductNDC>42571-348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibric Acid</ProprietaryName>
<NonProprietaryName>Fenofibric Acid</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213450</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>FENOFIBRIC ACID</SubstanceName>
<StrengthNumber>135</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibricacid delayed-release capsules are indicated as adjunctive therapy to diet: 1 toreduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL)., 2 toreduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy isnot possible.</IndicationAndUsage>
<Description>Fenofibric acid delayed-release capsules (fenofibric acid) are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5and the molecular weight is 421.91. Choline fenofibrate is freely soluble in methanol, sparingly soluble in ethanol and water, slightly soluble in DMSO and practically insoluble in dichloromethane. The melting point is approximately 210°C. Choline fenofibrate is a white to off white crystalline powder, which is stable under ordinary conditions. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: hypromellose, hydroxypropyl cellulose, methacrylic acid - ethyl acrylate copolymer (1:1) type A , microcrystalline cellulose, povidone K30, silicon dioxide, sodium stearyl fumarate, talc, triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: ferrosoferric oxide, ferric oxide red, gelatin and titanium dioxide. The capsule shell of the 135 mg capsule contains the following inactive ingredients: FD&C blue no.1, FD&C red no.3, FD&C red no. 40, gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42806-348-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-348-05) </PackageDescription>
<NDC11Code>42806-0348-05</NDC11Code>
<ProductNDC>42806-348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207224</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1).</IndicationAndUsage>
<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 150 mg and 300 mg white, round, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: colloidal silicon dioxide, copovidone, ethyl cellulose, hydroxypropyl cellulose, glyceryl behenate, methacrylic acid copolymer and silicon dioxide. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>49643-348-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-348-05) </PackageDescription>
<NDC11Code>49643-0348-05</NDC11Code>
<ProductNDC>49643-348</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Winterfat Pollen</ProprietaryName>
<NonProprietaryName>Eurotia Lanata</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>KRASCHENINNIKOVIA LANATA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>50419-348-05</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (50419-348-05) / 50 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50419-0348-05</NDC11Code>
<ProductNDC>50419-348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultravist</ProprietaryName>
<NonProprietaryName>Iopromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20220608</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020220</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IOPROMIDE</SubstanceName>
<StrengthNumber>370</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTRAVIST® Injection is an iodinated contrast agent indicated for.</IndicationAndUsage>
<Description>ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water).</Description>
</NDC>
<NDC>
<NDCCode>51991-348-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (51991-348-05) </PackageDescription>
<NDC11Code>51991-0348-05</NDC11Code>
<ProductNDC>51991-348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204921</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide tablets are indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1).</IndicationAndUsage>
<Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>52959-348-05</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 BOTTLE (52959-348-05)</PackageDescription>
<NDC11Code>52959-0348-05</NDC11Code>
<ProductNDC>52959-348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19771121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085966</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<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-5H-dibenzo[a,d] cycloheptene-Δ5, 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 silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn) and titanium dioxide. The 10 mg also includes D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake; 25 mg – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake; 50 mg – FD&C Blue #2 Aluminum Lake and FD&C Red #40 Aluminum Lake; 75 mg – D&C Red #7 Calcium Lake and FD&C Blue #2 Aluminum Lake; 100 mg – D&C Red #30 Aluminum Lake and D&C Yellow #10 Aluminum Lake; 150 mg – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>68428-348-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-348-05) </PackageDescription>
<NDC11Code>68428-0348-05</NDC11Code>
<ProductNDC>68428-348</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cuprum Arsenicosum</ProprietaryName>
<NonProprietaryName>Cupric Arsenite</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CUPRIC ARSENITE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71948-101-05</NDCCode>
<PackageDescription>5 PATCH in 1 PACKAGE (71948-101-05) > .348 g in 1 PATCH</PackageDescription>
<NDC11Code>71948-0101-05</NDC11Code>
<ProductNDC>71948-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The Black Patch</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171230</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Carbon Innovation, Inc.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-348-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84756-348-05) </PackageDescription>
<NDC11Code>84756-0348-05</NDC11Code>
<ProductNDC>84756-348</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Intensive Moisturizes Cream</ProprietaryName>
<NonProprietaryName>Intensive Moisturizes Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-002-05</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 BOTTLE (71205-002-05) </PackageDescription>
<NDC11Code>71205-0002-05</NDC11Code>
<ProductNDC>71205-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202801</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section.</IndicationAndUsage>
<Description>Levofloxacin, USP is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate.Figure 1: The Chemical Structure of Levofloxacin, USPThe molecular formula is C18H20FN3O4 1/2 H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9.Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage FormLevofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg: croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 500 mg: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 750 mg: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.Levofloxacin tablets, USP meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71205-051-05</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (71205-051-05) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>71205-0051-05</NDC11Code>
<ProductNDC>71205-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076749</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE; ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>.5; 3</StrengthNumber>
<StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.</IndicationAndUsage>
<Description>The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-Butylamino) methyl]-4-hydroxy- m-xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3 H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see Error! Hyperlink reference not valid.).</Description>
</NDC>
<NDC>
<NDCCode>71205-089-05</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (71205-089-05) </PackageDescription>
<NDC11Code>71205-0089-05</NDC11Code>
<ProductNDC>71205-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040611</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-10-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 1. Endocrine Disorders:. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler's syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21H26O5. Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structural formula:. Molecular weight: 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. Each tablet, for oral administration, contains 1 mg of prednisone. Inactive Ingredients: Lactose, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate.</Description>
</NDC>
<NDC>
<NDCCode>71205-101-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71205-101-05) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71205-0101-05</NDC11Code>
<ProductNDC>71205-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20170705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207444</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children.</IndicationAndUsage>
<Description>Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin ophthalmic solution USP, 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: Benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is. Molecular Weight = 467.52. Molecular Formula: C18H37N5O9. Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine.</Description>
</NDC>
<NDC>
<NDCCode>71205-115-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (71205-115-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>71205-0115-05</NDC11Code>
<ProductNDC>71205-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ketotifen Fumarate</ProprietaryName>
<NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077958</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
<StrengthNumber>.35</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-200-05</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (71205-200-05) </PackageDescription>
<NDC11Code>71205-0200-05</NDC11Code>
<ProductNDC>71205-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070108</StartMarketingDate>
<EndMarketingDate>20210930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071141</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<EndMarketingDatePackage>20190930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-234-05</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 BOTTLE (71205-234-05) </PackageDescription>
<NDC11Code>71205-0234-05</NDC11Code>
<ProductNDC>71205-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200839</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) Plague in adult and pediatric patients (1.8) Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) Acute Pyelonephritis (1.11) Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) Acute Bacterial Sinusitis (1.14). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).</IndicationAndUsage>
<Description>Levofloxacin USP is a synthetic antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (--(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate.Figure 1: The Chemical Structure of Levofloxacin USP. The molecular formula is C18H20FN3O4½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Levofloxacin USP are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide. , 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides. , 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>71205-235-05</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (71205-235-05) </PackageDescription>
<NDC11Code>71205-0235-05</NDC11Code>
<ProductNDC>71205-235</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078203</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose anhydrous, microcrystalline cellulose, polacrilin potassium and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>71205-239-05</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (71205-239-05) </PackageDescription>
<NDC11Code>71205-0239-05</NDC11Code>
<ProductNDC>71205-239</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085161</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets, USP are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C21H26O5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone, USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone tablets, USP 20 mg also contain FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>71205-296-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (71205-296-05) </PackageDescription>
<NDC11Code>71205-0296-05</NDC11Code>
<ProductNDC>71205-296</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20091105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076583</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.</IndicationAndUsage>
<Description>Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution contains a racemic mixture of R-( + ) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of Ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of Ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>71205-300-05</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (71205-300-05) > 5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>71205-0300-05</NDC11Code>
<ProductNDC>71205-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077568</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Corneal Ulcers:. Pseudomonas aeruginosa. Serratia marcescens *. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. Streptococcus (Viridans Group) *. Conjunctivitis:. Haemophilus influenzae. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Ciprofloxacin Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin Ophthalmic Solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactives: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.</Description>
</NDC>
<NDC>
<NDCCode>71205-302-05</NDCCode>
<PackageDescription>5 PATCH in 1 POUCH (71205-302-05) > 1 g in 1 PATCH</PackageDescription>
<NDC11Code>71205-0302-05</NDC11Code>
<ProductNDC>71205-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidozen</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride, Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>40; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-333-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, PLASTIC (71205-333-05) </PackageDescription>
<NDC11Code>71205-0333-05</NDC11Code>
<ProductNDC>71205-333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentamicin Sulfate</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19960405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062196</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>GENTAMICIN SULFATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Gentamicin Sulfate Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.</IndicationAndUsage>
<Description>DESCRIPTION: Gentamicin Sulfate is a water-soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to approximately pH 7 for ophthalmic use. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as white powder and is soluble in water and insoluble in alcohol. The structure is as follows. Established name: Gentamicin Sulfate. Chemical name: 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine. Ingredients: Each mL contains: Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin). Preservative: Benzalkonium Chloride 0.1 mg (0.01%). Inactives: Sodium Chloride, Dried Sodium Phosphate, Tyloxapol, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>71205-334-05</NDCCode>
<PackageDescription>5 PATCH in 1 POUCH (71205-334-05) / 1 g in 1 PATCH</PackageDescription>
<NDC11Code>71205-0334-05</NDC11Code>
<ProductNDC>71205-334</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menthozen Hydrogel</ProprietaryName>
<NonProprietaryName>Menthol, Capsaicin</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM; CAPSAICIN</SubstanceName>
<StrengthNumber>40; .3</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-345-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71205-345-05) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71205-0345-05</NDC11Code>
<ProductNDC>71205-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olopatadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206306</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olopatadine hydrochloride ophthalmic solution USP, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.</IndicationAndUsage>
<Description>Olopatadine hydrochloride ophthalmic solution USP, 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1 -receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 373.88. The chemical structure is presented below. Chemical Name: 11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e] oxepin-2-acetic acid hydrochloride. Each mL of Olopatadine hydrochloride ophthalmic solution, USP contains:. Active: 1.11 mg olopatadine hydrochloride, USP equivalent to 1 mg olopatadine. Preservative: benzalkonium chloride 0.01%. Inactives: dibasic sodium phosphate; sodium chloride; hydrochloric acid/sodium hydroxide (adjust pH); and water for injection. It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>71205-362-05</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (71205-362-05) </PackageDescription>
<NDC11Code>71205-0362-05</NDC11Code>
<ProductNDC>71205-362</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085162</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets, USP are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C21H26O5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 10 mg of prednisone, USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone tablets, USP 20 mg also contain FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>71205-403-05</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE, PLASTIC (71205-403-05) </PackageDescription>
<NDC11Code>71205-0403-05</NDC11Code>
<ProductNDC>71205-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210525</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200319</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>