{
"NDC": [
{
"NDCCode": "33261-152-09",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (33261-152-09) > 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (33261-152-30)",
"NDC11Code": "33261-0152-09",
"ProductNDC": "33261-152",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adult Low Dose Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product."
},
{
"NDCCode": "33261-152-00",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (33261-152-00)",
"NDC11Code": "33261-0152-00",
"ProductNDC": "33261-152",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adult Low Dose Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product."
},
{
"NDCCode": "33261-152-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (33261-152-60)",
"NDC11Code": "33261-0152-60",
"ProductNDC": "33261-152",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adult Low Dose Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product."
},
{
"NDCCode": "33261-152-90",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (33261-152-90)",
"NDC11Code": "33261-0152-90",
"ProductNDC": "33261-152",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adult Low Dose Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product."
},
{
"NDCCode": "33261-062-09",
"PackageDescription": "9 TABLET in 1 BOTTLE (33261-062-09)",
"NDC11Code": "33261-0062-09",
"ProductNDC": "33261-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "33261-105-09",
"PackageDescription": "9 TABLET, COATED in 1 BOTTLE (33261-105-09)",
"NDC11Code": "33261-0105-09",
"ProductNDC": "33261-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076003",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults.",
"Description": "Tramadol hydrochloride tablets, USP are a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H25NO2HCl and its molecular weight is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet, USP intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "33261-147-09",
"PackageDescription": "9 CAPSULE in 1 BOTTLE, PLASTIC (33261-147-09)",
"NDC11Code": "33261-0147-09",
"ProductNDC": "33261-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040627",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Benzonatate is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow # 10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide."
},
{
"NDCCode": "33261-150-09",
"PackageDescription": "9 TABLET in 1 BOTTLE, PLASTIC (33261-150-09)",
"NDC11Code": "33261-0150-09",
"ProductNDC": "33261-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hydrochloride",
"NonProprietaryName": "Phenazopyridine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.).",
"Description": "Phenazopyridine Hydrochloride is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch."
},
{
"NDCCode": "33261-417-09",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-417-09)",
"NDC11Code": "33261-0417-09",
"ProductNDC": "33261-417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078539",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. . Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. . Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline.Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch, magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red.Meets USP dissolution test 6."
},
{
"NDCCode": "30142-152-09",
"PackageDescription": "9 mL in 1 BOTTLE, WITH APPLICATOR (30142-152-09) ",
"NDC11Code": "30142-0152-09",
"ProductNDC": "30142-152",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Wart Remover Liquid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171206",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M028",
"LabelerName": "Kroger Co.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".17",
"StrengthUnit": "mg/9mL",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171206",
"SamplePackage": "N",
"IndicationAndUsage": "for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. The plantar wart exists only on the bottom of the foot and interrupts footprint pattern."
},
{
"NDCCode": "64220-152-09",
"PackageDescription": "50 kg in 1 DRUM (64220-152-09)",
"NDC11Code": "64220-0152-09",
"ProductNDC": "64220-152",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110209",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2019-02-23",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "68180-152-09",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-152-09) ",
"NDC11Code": "68180-0152-09",
"ProductNDC": "68180-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirabegron",
"NonProprietaryName": "Mirabegron",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209485",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "MIRABEGRON",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: 1 Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1.1).",
"Description": "Mirabegron extended-release tablet for oral use is a beta-3 adrenergic agonist. The chemical name of mirabegron is 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{([(2R)-2-hydroxy-2-phenylethyl] amino}ethyl)phenyl] acetamide having an empirical formula of C21H24N4O2S and a molecular weight of 396.51. The structural formula of mirabegron is. Mirabegron is an off-white to light yellow colored powder. It is practically insoluble in water. It is soluble in methanol and dimethyl sulfoxide. Each mirabegron extended-release tablet for oral use contains either 25 mg or 50 mg of mirabegron and the following inactive ingredients: butylated hydroxytoluene, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6, hydroxy propyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, titanium dioxide, triacetin."
},
{
"NDCCode": "71919-152-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-152-09) ",
"NDC11Code": "71919-0152-09",
"ProductNDC": "71919-152",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Silicata",
"NonProprietaryName": "Calcium Silicate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120713",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM SILICATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120713",
"SamplePackage": "N"
},
{
"NDCCode": "82804-152-09",
"PackageDescription": "9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-152-09) ",
"NDC11Code": "82804-0152-09",
"ProductNDC": "82804-152",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simethicone 125 Mg",
"NonProprietaryName": "Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180425",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240925",
"SamplePackage": "N",
"IndicationAndUsage": "relieves bloating, pressure and fullness commonly referred to as gas."
},
{
"NDCCode": "83589-152-09",
"PackageDescription": "100 g in 1 BAG (83589-152-09) ",
"NDC11Code": "83589-0152-09",
"ProductNDC": "83589-152",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ghrp-6 Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260225",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
"SubstanceName": "HEXAPEPTIDE-2",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "25-FEB-26"
},
{
"NDCCode": "33261-873-01",
"PackageDescription": "60 POWDER in 1 INHALER (33261-873-01)",
"NDC11Code": "33261-0873-01",
"ProductNDC": "33261-873",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Advair",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20010228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021077",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
"StrengthNumber": "50; 100",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "ADVAIR DISKUS is a combination product containing a corticosteroid and a LABA indicated for: 1 Treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The chemical name of salmeterol xinafoate is 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate, and it has the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are specially designed plastic devices containing a double-foil blister strip of a powder formulation of fluticasone propionate and salmeterol xinafoate intended for oral inhalation only. Each blister on the double-foil strip within the device contains 100, 250, or 500 mcg of microfine fluticasone propionate and 72.5 mcg of microfine salmeterol xinafoate salt, equivalent to 50 mcg of salmeterol base, in 12.5 mg of formulation containing lactose (which contains milk proteins). Each blister contains 1 complete dose of both medications. After a blister containing medication is opened by activating the device, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, 250/50, and 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS® inhalation device was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) patients with asthma inhaling maximally through the DISKUS device show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric patients with asthma inhaling maximally through the DISKUS device show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old patient set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old patient set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "33261-874-01",
"PackageDescription": "60 POWDER in 1 INHALER (33261-874-01)",
"NDC11Code": "33261-0874-01",
"ProductNDC": "33261-874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Advair",
"ProprietaryNameSuffix": "Diskus",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20010205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021077",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
"StrengthNumber": "50; 250",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "ADVAIR DISKUS is a combination product containing a corticosteroid and a LABA indicated for: 1 Treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The chemical name of salmeterol xinafoate is 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate, and it has the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are specially designed plastic devices containing a double-foil blister strip of a powder formulation of fluticasone propionate and salmeterol xinafoate intended for oral inhalation only. Each blister on the double-foil strip within the device contains 100, 250, or 500 mcg of microfine fluticasone propionate and 72.5 mcg of microfine salmeterol xinafoate salt, equivalent to 50 mcg of salmeterol base, in 12.5 mg of formulation containing lactose (which contains milk proteins). Each blister contains 1 complete dose of both medications. After a blister containing medication is opened by activating the device, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, 250/50, and 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS® inhalation device was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) patients with asthma inhaling maximally through the DISKUS device show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric patients with asthma inhaling maximally through the DISKUS device show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old patient set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old patient set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0093-7516-31",
"PackageDescription": "1 POUCH in 1 CARTON (0093-7516-31) > 1 INHALER in 1 POUCH > 60 POWDER in 1 INHALER",
"NDC11Code": "00093-7516-31",
"ProductNDC": "0093-7516",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate And Salmeterol",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213948",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "500; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220323",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder, USP is fluticasone propionate USP, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate, USP is a white powder with a molecular weight of 500.57, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder, USP is salmeterol xinafoate USP, a beta2-adrenergic bronchodilator. Salmeterol xinafoate, USP is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate, USP is a white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder, USP is supplied in a green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate, USP (100, 250, or 500 mcg) and micronized salmeterol xinafoate, USP salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder inhaler delivers 93, 233, and 465 mcg of fluticasone propionate, USP and 45 mcg of salmeterol base, per blister from fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0093-7517-31",
"PackageDescription": "1 POUCH in 1 CARTON (0093-7517-31) > 1 INHALER in 1 POUCH > 60 POWDER in 1 INHALER",
"NDC11Code": "00093-7517-31",
"ProductNDC": "0093-7517",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate And Salmeterol",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213948",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "100; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220323",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder, USP is fluticasone propionate USP, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate, USP is a white powder with a molecular weight of 500.57, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder, USP is salmeterol xinafoate USP, a beta2-adrenergic bronchodilator. Salmeterol xinafoate, USP is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate, USP is a white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder, USP is supplied in a green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate, USP (100, 250, or 500 mcg) and micronized salmeterol xinafoate, USP salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder inhaler delivers 93, 233, and 465 mcg of fluticasone propionate, USP and 45 mcg of salmeterol base, per blister from fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0093-7518-31",
"PackageDescription": "1 POUCH in 1 CARTON (0093-7518-31) > 1 INHALER in 1 POUCH > 60 POWDER in 1 INHALER",
"NDC11Code": "00093-7518-31",
"ProductNDC": "0093-7518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate And Salmeterol",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213948",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "250; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220323",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder, USP is fluticasone propionate USP, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate, USP is a white powder with a molecular weight of 500.57, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder, USP is salmeterol xinafoate USP, a beta2-adrenergic bronchodilator. Salmeterol xinafoate, USP is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate, USP is a white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder, USP is supplied in a green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate, USP (100, 250, or 500 mcg) and micronized salmeterol xinafoate, USP salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder inhaler delivers 93, 233, and 465 mcg of fluticasone propionate, USP and 45 mcg of salmeterol base, per blister from fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0378-9320-32",
"PackageDescription": "1 INHALER in 1 CARTON (0378-9320-32) > 60 POWDER in 1 INHALER",
"NDC11Code": "00378-9320-32",
"ProductNDC": "0378-9320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wixela Inhub",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20190211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208891",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "100; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190211",
"SamplePackage": "N",
"IndicationAndUsage": "Wixela Inhub® is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: : 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1) , 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub® is fluticasone propionate, a corticosteroid having the chemical name S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub® is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-m-xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure. Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2."
},
{
"NDCCode": "0378-9321-32",
"PackageDescription": "1 INHALER in 1 CARTON (0378-9321-32) > 60 POWDER in 1 INHALER",
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"ProductNDC": "0378-9321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wixela Inhub",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20190211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208891",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "250; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190211",
"SamplePackage": "N",
"IndicationAndUsage": "Wixela Inhub® is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: : 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1) , 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub® is fluticasone propionate, a corticosteroid having the chemical name S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub® is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-m-xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure. Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2."
},
{
"NDCCode": "0378-9322-32",
"PackageDescription": "1 INHALER in 1 CARTON (0378-9322-32) > 60 POWDER in 1 INHALER",
"NDC11Code": "00378-9322-32",
"ProductNDC": "0378-9322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wixela Inhub",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20190211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208891",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "500; 50",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190211",
"SamplePackage": "N",
"IndicationAndUsage": "Wixela Inhub® is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: : 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1) , 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
"Description": "Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub® is fluticasone propionate, a corticosteroid having the chemical name S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub® is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-m-xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure. Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2."
},
{
"NDCCode": "10191-1002-2",
"PackageDescription": "152 PELLET in 1 VIAL, GLASS (10191-1002-2)",
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"ProductNDC": "10191-1002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphinum",
"NonProprietaryName": "Morphine",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20150723",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Remedy Makers",
"SubstanceName": "ABT-925 ANHYDROUS FREE BASE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10191-1589-2",
"PackageDescription": "152 PELLET in 1 VIAL, GLASS (10191-1589-2)",
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"ProductNDC": "10191-1589",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sulphur",
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"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
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"LabelerName": "Remedy Makers",
"SubstanceName": "SULFUR",
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"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
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"IndicationAndUsage": "Free from yeast, wheat, corn, and soy.DIRECTIONS: Dissolve 3 or 4 pelletsin mouth or under tongue 3 times a day or as directed by a physician.Children 2 years and older take 1/2adult dose.INDICATIONS: To be used accordingto standard homeopathic indicationsfor self limiting conditions such asthose indicated on the front panel or as directed by a physician.Warnings: *Use only if cap andseal are unbroken. * Keep this and all medications out of reach of children.* If symptoms persist for more then 3days, consult your physician. *As with any drug, if your are pregnant or nursing a baby, seek the advice of ahealth professional before using this product.*Store tightly closed in a cool, dark place.Made according to The Homeopathic Pharmacopoeia of the United States by: Remedy Makers, Pomona, CA 91768."
},
{
"NDCCode": "10191-1603-2",
"PackageDescription": "152 PELLET in 1 VIAL, GLASS (10191-1603-2)",
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"ProductNDC": "10191-1603",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Symphytum Officinale",
"NonProprietaryName": "Comfrey Plant",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20040204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "REMEDY MAKERS",
"SubstanceName": "COMFREY LEAF",
"StrengthNumber": "12",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11025-118-14",
"PackageDescription": "250 g in 1 JAR (11025-118-14) ",
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"ProductNDC": "11025-118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermocrem",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060530",
"EndMarketingDate": "20230312",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "INTERNATIONAL ETHICAL LABS, INC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "152.5",
"StrengthUnit": "mg/g",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N"
},
{
"NDCCode": "11086-152-55",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Keralyt",
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"RouteName": "TOPICAL",
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"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Summers Laboratories Inc",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11523-7325-2",
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"ProductTypeName": "HUMAN OTC DRUG",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
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"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
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"PackageNdcExcludeFlag": "N",
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},
{
"NDCCode": "11523-7467-1",
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"ProductTypeName": "HUMAN OTC DRUG",
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"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
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"PackageNdcExcludeFlag": "N",
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<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33261-062-09</NDCCode>
<PackageDescription>9 TABLET in 1 BOTTLE (33261-062-09)</PackageDescription>
<NDC11Code>33261-0062-09</NDC11Code>
<ProductNDC>33261-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>33261-105-09</NDCCode>
<PackageDescription>9 TABLET, COATED in 1 BOTTLE (33261-105-09)</PackageDescription>
<NDC11Code>33261-0105-09</NDC11Code>
<ProductNDC>33261-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076003</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP are a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H25NO2HCl and its molecular weight is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet, USP intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>33261-147-09</NDCCode>
<PackageDescription>9 CAPSULE in 1 BOTTLE, PLASTIC (33261-147-09)</PackageDescription>
<NDC11Code>33261-0147-09</NDC11Code>
<ProductNDC>33261-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040627</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Benzonatate is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow # 10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>33261-150-09</NDCCode>
<PackageDescription>9 TABLET in 1 BOTTLE, PLASTIC (33261-150-09)</PackageDescription>
<NDC11Code>33261-0150-09</NDC11Code>
<ProductNDC>33261-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenazopyridine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.).</IndicationAndUsage>
<Description>Phenazopyridine Hydrochloride is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>33261-417-09</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-417-09)</PackageDescription>
<NDC11Code>33261-0417-09</NDC11Code>
<ProductNDC>33261-417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078539</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. . Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. . Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline.Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch, magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red.Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>30142-152-09</NDCCode>
<PackageDescription>9 mL in 1 BOTTLE, WITH APPLICATOR (30142-152-09) </PackageDescription>
<NDC11Code>30142-0152-09</NDC11Code>
<ProductNDC>30142-152</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Wart Remover Liquid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M028</ApplicationNumber>
<LabelerName>Kroger Co.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.17</StrengthNumber>
<StrengthUnit>mg/9mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. The plantar wart exists only on the bottom of the foot and interrupts footprint pattern.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64220-152-09</NDCCode>
<PackageDescription>50 kg in 1 DRUM (64220-152-09)</PackageDescription>
<NDC11Code>64220-0152-09</NDC11Code>
<ProductNDC>64220-152</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110209</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2019-02-23</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68180-152-09</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-152-09) </PackageDescription>
<NDC11Code>68180-0152-09</NDC11Code>
<ProductNDC>68180-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirabegron</ProprietaryName>
<NonProprietaryName>Mirabegron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209485</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MIRABEGRON</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: 1 Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1.1).</IndicationAndUsage>
<Description>Mirabegron extended-release tablet for oral use is a beta-3 adrenergic agonist. The chemical name of mirabegron is 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{([(2R)-2-hydroxy-2-phenylethyl] amino}ethyl)phenyl] acetamide having an empirical formula of C21H24N4O2S and a molecular weight of 396.51. The structural formula of mirabegron is. Mirabegron is an off-white to light yellow colored powder. It is practically insoluble in water. It is soluble in methanol and dimethyl sulfoxide. Each mirabegron extended-release tablet for oral use contains either 25 mg or 50 mg of mirabegron and the following inactive ingredients: butylated hydroxytoluene, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6, hydroxy propyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71919-152-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-152-09) </PackageDescription>
<NDC11Code>71919-0152-09</NDC11Code>
<ProductNDC>71919-152</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Silicata</ProprietaryName>
<NonProprietaryName>Calcium Silicate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120713</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALCIUM SILICATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>82804-152-09</NDCCode>
<PackageDescription>9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-152-09) </PackageDescription>
<NDC11Code>82804-0152-09</NDC11Code>
<ProductNDC>82804-152</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simethicone 125 Mg</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180425</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves bloating, pressure and fullness commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83589-152-09</NDCCode>
<PackageDescription>100 g in 1 BAG (83589-152-09) </PackageDescription>
<NDC11Code>83589-0152-09</NDC11Code>
<ProductNDC>83589-152</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ghrp-6 Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260225</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>HEXAPEPTIDE-2</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-FEB-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>33261-873-01</NDCCode>
<PackageDescription>60 POWDER in 1 INHALER (33261-873-01)</PackageDescription>
<NDC11Code>33261-0873-01</NDC11Code>
<ProductNDC>33261-873</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Advair</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20010228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021077</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50; 100</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ADVAIR DISKUS is a combination product containing a corticosteroid and a LABA indicated for: 1 Treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The chemical name of salmeterol xinafoate is 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate, and it has the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are specially designed plastic devices containing a double-foil blister strip of a powder formulation of fluticasone propionate and salmeterol xinafoate intended for oral inhalation only. Each blister on the double-foil strip within the device contains 100, 250, or 500 mcg of microfine fluticasone propionate and 72.5 mcg of microfine salmeterol xinafoate salt, equivalent to 50 mcg of salmeterol base, in 12.5 mg of formulation containing lactose (which contains milk proteins). Each blister contains 1 complete dose of both medications. After a blister containing medication is opened by activating the device, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, 250/50, and 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS® inhalation device was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) patients with asthma inhaling maximally through the DISKUS device show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric patients with asthma inhaling maximally through the DISKUS device show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old patient set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old patient set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>33261-874-01</NDCCode>
<PackageDescription>60 POWDER in 1 INHALER (33261-874-01)</PackageDescription>
<NDC11Code>33261-0874-01</NDC11Code>
<ProductNDC>33261-874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Advair</ProprietaryName>
<ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20010205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021077</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50; 250</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ADVAIR DISKUS is a combination product containing a corticosteroid and a LABA indicated for: 1 Treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The chemical name of salmeterol xinafoate is 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate, and it has the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are specially designed plastic devices containing a double-foil blister strip of a powder formulation of fluticasone propionate and salmeterol xinafoate intended for oral inhalation only. Each blister on the double-foil strip within the device contains 100, 250, or 500 mcg of microfine fluticasone propionate and 72.5 mcg of microfine salmeterol xinafoate salt, equivalent to 50 mcg of salmeterol base, in 12.5 mg of formulation containing lactose (which contains milk proteins). Each blister contains 1 complete dose of both medications. After a blister containing medication is opened by activating the device, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, 250/50, and 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS® inhalation device was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) patients with asthma inhaling maximally through the DISKUS device show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric patients with asthma inhaling maximally through the DISKUS device show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old patient set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old patient set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0093-7516-31</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0093-7516-31) > 1 INHALER in 1 POUCH > 60 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00093-7516-31</NDC11Code>
<ProductNDC>0093-7516</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213948</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>500; 50</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder, USP is fluticasone propionate USP, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate, USP is a white powder with a molecular weight of 500.57, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder, USP is salmeterol xinafoate USP, a beta2-adrenergic bronchodilator. Salmeterol xinafoate, USP is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate, USP is a white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder, USP is supplied in a green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate, USP (100, 250, or 500 mcg) and micronized salmeterol xinafoate, USP salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder inhaler delivers 93, 233, and 465 mcg of fluticasone propionate, USP and 45 mcg of salmeterol base, per blister from fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0093-7517-31</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0093-7517-31) > 1 INHALER in 1 POUCH > 60 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00093-7517-31</NDC11Code>
<ProductNDC>0093-7517</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213948</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder, USP is fluticasone propionate USP, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate, USP is a white powder with a molecular weight of 500.57, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder, USP is salmeterol xinafoate USP, a beta2-adrenergic bronchodilator. Salmeterol xinafoate, USP is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate, USP is a white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder, USP is supplied in a green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate, USP (100, 250, or 500 mcg) and micronized salmeterol xinafoate, USP salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder inhaler delivers 93, 233, and 465 mcg of fluticasone propionate, USP and 45 mcg of salmeterol base, per blister from fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0093-7518-31</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0093-7518-31) > 1 INHALER in 1 POUCH > 60 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00093-7518-31</NDC11Code>
<ProductNDC>0093-7518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213948</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>250; 50</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder, USP is fluticasone propionate USP, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate, USP is a white powder with a molecular weight of 500.57, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder, USP is salmeterol xinafoate USP, a beta2-adrenergic bronchodilator. Salmeterol xinafoate, USP is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate, USP is a white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder, USP is supplied in a green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate, USP (100, 250, or 500 mcg) and micronized salmeterol xinafoate, USP salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder inhaler delivers 93, 233, and 465 mcg of fluticasone propionate, USP and 45 mcg of salmeterol base, per blister from fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0378-9320-32</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0378-9320-32) > 60 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00378-9320-32</NDC11Code>
<ProductNDC>0378-9320</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wixela Inhub</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20190211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208891</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Wixela Inhub® is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: : 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1) , 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub® is fluticasone propionate, a corticosteroid having the chemical name S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub® is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-m-xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure. Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0378-9321-32</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0378-9321-32) > 60 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00378-9321-32</NDC11Code>
<ProductNDC>0378-9321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wixela Inhub</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20190211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208891</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>250; 50</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Wixela Inhub® is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: : 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1) , 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub® is fluticasone propionate, a corticosteroid having the chemical name S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub® is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-m-xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure. Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0378-9322-32</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (0378-9322-32) > 60 POWDER in 1 INHALER</PackageDescription>
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<ProductNDC>0378-9322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wixela Inhub</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20190211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208891</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
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<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Wixela Inhub® is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: : 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1) , 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
<Description>Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub® is fluticasone propionate, a corticosteroid having the chemical name S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub® is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-m-xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure. Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>10191-1002-2</NDCCode>
<PackageDescription>152 PELLET in 1 VIAL, GLASS (10191-1002-2)</PackageDescription>
<NDC11Code>10191-1002-02</NDC11Code>
<ProductNDC>10191-1002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphinum</ProprietaryName>
<NonProprietaryName>Morphine</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20150723</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Remedy Makers</LabelerName>
<SubstanceName>ABT-925 ANHYDROUS FREE BASE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10191-1589-2</NDCCode>
<PackageDescription>152 PELLET in 1 VIAL, GLASS (10191-1589-2)</PackageDescription>
<NDC11Code>10191-1589-02</NDC11Code>
<ProductNDC>10191-1589</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sulphur</ProprietaryName>
<NonProprietaryName>Sulfur</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20020909</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Remedy Makers</LabelerName>
<SubstanceName>SULFUR</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Free from yeast, wheat, corn, and soy.DIRECTIONS: Dissolve 3 or 4 pelletsin mouth or under tongue 3 times a day or as directed by a physician.Children 2 years and older take 1/2adult dose.INDICATIONS: To be used accordingto standard homeopathic indicationsfor self limiting conditions such asthose indicated on the front panel or as directed by a physician.Warnings: *Use only if cap andseal are unbroken. * Keep this and all medications out of reach of children.* If symptoms persist for more then 3days, consult your physician. *As with any drug, if your are pregnant or nursing a baby, seek the advice of ahealth professional before using this product.*Store tightly closed in a cool, dark place.Made according to The Homeopathic Pharmacopoeia of the United States by: Remedy Makers, Pomona, CA 91768.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10191-1603-2</NDCCode>
<PackageDescription>152 PELLET in 1 VIAL, GLASS (10191-1603-2)</PackageDescription>
<NDC11Code>10191-1603-02</NDC11Code>
<ProductNDC>10191-1603</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Symphytum Officinale</ProprietaryName>
<NonProprietaryName>Comfrey Plant</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20040204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>REMEDY MAKERS</LabelerName>
<SubstanceName>COMFREY LEAF</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11025-118-14</NDCCode>
<PackageDescription>250 g in 1 JAR (11025-118-14) </PackageDescription>
<NDC11Code>11025-0118-14</NDC11Code>
<ProductNDC>11025-118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermocrem</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060530</StartMarketingDate>
<EndMarketingDate>20230312</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>INTERNATIONAL ETHICAL LABS, INC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>152.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-03-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160608</StartMarketingDatePackage>
<EndMarketingDatePackage>20230308</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11086-152-55</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (11086-152-55) > 177 mL in 1 BOTTLE (11086-152-05)</PackageDescription>
<NDC11Code>11086-0152-55</NDC11Code>
<ProductNDC>11086-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Keralyt</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131030</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Summers Laboratories Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11523-7325-2</NDCCode>
<PackageDescription>89 mL in 1 BOTTLE, PLASTIC (11523-7325-2) </PackageDescription>
<NDC11Code>11523-7325-02</NDC11Code>
<ProductNDC>11523-7325</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coppertone Sport</ProprietaryName>
<ProprietaryNameSuffix>Spf 100</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990521</StartMarketingDate>
<EndMarketingDate>20210901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30.54; 152.7; 50.9; 101.8; 61.08</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171101</StartMarketingDatePackage>
<EndMarketingDatePackage>20210901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11523-7467-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (11523-7467-1) </PackageDescription>
<NDC11Code>11523-7467-01</NDC11Code>
<ProductNDC>11523-7467</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coppertone Kids Sport Spf 100</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<EndMarketingDate>20210901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; HOMOSALATE</SubstanceName>
<StrengthNumber>30.54; 50.9; 101.8; 61.08; 152.7</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<EndMarketingDatePackage>20210901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>