{
"NDC": [
{
"NDCCode": "65131-054-18",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (65131-054-18) > 120 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "65131-0054-18",
"ProductNDC": "65131-054",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Broncochem",
"ProprietaryNameSuffix": "Kids Cold And Flu",
"NonProprietaryName": "Acetaminophen-phenylephrine Hcl-guaifenesin",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20170501",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "LABORATORIO MAGNACHEM INTERNATIONAL SRL",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "325; 5; 200",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2017-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170501",
"SamplePackage": "N",
"IndicationAndUsage": "Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat."
},
{
"NDCCode": "35192-054-18",
"PackageDescription": "59 g in 1 JAR (35192-054-18) ",
"NDC11Code": "35192-0054-18",
"ProductNDC": "35192-054",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sea-laminaria Kelp Day Cream Spf 30",
"NonProprietaryName": "Sunscreen",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250113",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "CA-Botana International INC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "25",
"StrengthUnit": "g/25g",
"Status": "Deprecated",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250113",
"SamplePackage": "N",
"IndicationAndUsage": "Apply liberally 15 minutes before exposure, use waterresistant sunscreen, if swimming or sweating reaply at least every 2 hours Children under 6 months: ask a doctor."
},
{
"NDCCode": "64330-054-35",
"PackageDescription": "18 kg in 1 DRUM (64330-054-35) ",
"NDC11Code": "64330-0054-35",
"ProductNDC": "64330-054",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zaleplon",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180105",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Centaur Pharmaceuticals Private Limited",
"SubstanceName": "ZALEPLON",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2026-08-27",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "22-NOV-20"
},
{
"NDCCode": "64330-054-37",
"PackageDescription": "18.5 kg in 1 DRUM (64330-054-37) ",
"NDC11Code": "64330-0054-37",
"ProductNDC": "64330-054",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zaleplon",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180105",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Centaur Pharmaceuticals Private Limited",
"SubstanceName": "ZALEPLON",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2026-08-27",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "12-JAN-21"
},
{
"NDCCode": "71919-822-18",
"PackageDescription": "50 VIAL, GLASS in 1 KIT (71919-822-18) / 1 KIT in 1 VIAL, GLASS (71919-822-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 750 PELLET in 1 VIAL, GLASS (68428-069-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-064-01) * 750 PELLET in 1 VIAL, GLASS (71919-814-01) * 350 PELLET in 1 VIAL, GLASS (71919-770-01) * 750 PELLET in 1 VIAL, GLASS (68428-062-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-059-01) * 750 PELLET in 1 VIAL, GLASS (68428-058-01) * 750 PELLET in 1 VIAL, GLASS (68428-057-01) * 750 PELLET in 1 VIAL, GLASS (68428-056-01) * 350 PELLET in 1 VIAL, GLASS (71919-777-01) * 750 PELLET in 1 VIAL, GLASS (71919-813-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-053-01) * 750 PELLET in 1 VIAL, GLASS (68428-054-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 350 PELLET in 1 VIAL, GLASS (71919-763-01) * 750 PELLET in 1 VIAL, GLASS (68428-051-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-049-01) * 750 PELLET in 1 VIAL, GLASS (68428-048-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-041-01) * 750 PELLET in 1 VIAL, GLASS (68428-036-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-762-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-034-01) * 750 PELLET in 1 VIAL, GLASS (68428-040-01) * 750 PELLET in 1 VIAL, GLASS (68428-033-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (71919-812-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-026-01) ",
"NDC11Code": "71919-0822-18",
"ProductNDC": "71919-822",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "200c Homeopathic Remedy Kit",
"NonProprietaryName": "50 Remedy Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20240229",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": "Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts."
},
{
"NDCCode": "72578-054-18",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (72578-054-18) ",
"NDC11Code": "72578-0054-18",
"ProductNDC": "72578-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207774",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220110",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&C red 28, FD & C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide."
},
{
"NDCCode": "0264-1915-00",
"PackageDescription": "6 CARTON in 1 CASE (0264-1915-00) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-1915-00",
"ProductNDC": "0264-1915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Procalamine",
"NonProprietaryName": "Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19820506",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018582",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE",
"StrengthNumber": ".21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "0264-1915-07",
"PackageDescription": "6 CARTON in 1 CASE (0264-1915-07) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-1915-07",
"ProductNDC": "0264-1915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Procalamine",
"NonProprietaryName": "Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19820506",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018582",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE",
"StrengthNumber": ".21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Allergens [CS], Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19820506",
"SamplePackage": "N"
},
{
"NDCCode": "10544-054-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-054-30)",
"NDC11Code": "10544-0054-30",
"ProductNDC": "10544-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074342",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine and its structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored, and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake."
},
{
"NDCCode": "50090-3403-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-3403-0) ",
"NDC11Code": "50090-3403-00",
"ProductNDC": "50090-3403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078232",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "50090-3403-1",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (50090-3403-1) ",
"NDC11Code": "50090-3403-01",
"ProductNDC": "50090-3403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078232",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
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{
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"IndicationAndUsage": "Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
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{
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"IndicationAndUsage": "Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
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"IndicationAndUsage": "Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
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"IndicationAndUsage": "Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
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"IndicationAndUsage": "JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.",
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"IndicationAndUsage": "JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.",
"Description": "JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex."
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"IndicationAndUsage": "JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.",
"Description": "JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex."
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"IndicationAndUsage": "JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.",
"Description": "JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex."
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},
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"StrengthUnit": "kg/kg",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2026-08-27",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "05-JAN-18"
},
{
"NDCCode": "64330-054-15",
"PackageDescription": "25 kg in 1 DRUM (64330-054-15) ",
"NDC11Code": "64330-0054-15",
"ProductNDC": "64330-054",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zaleplon",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180105",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Centaur Pharmaceuticals Private Limited",
"SubstanceName": "ZALEPLON",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2026-08-27",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-SEP-18"
},
{
"NDCCode": "64330-054-27",
"PackageDescription": "2.7 kg in 1 DRUM (64330-054-27) ",
"NDC11Code": "64330-0054-27",
"ProductNDC": "64330-054",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zaleplon",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180105",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Centaur Pharmaceuticals Private Limited",
"SubstanceName": "ZALEPLON",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2026-08-27",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "18-FEB-18"
},
{
"NDCCode": "64330-054-28",
"PackageDescription": "2.15 kg in 1 DRUM (64330-054-28) ",
"NDC11Code": "64330-0054-28",
"ProductNDC": "64330-054",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zaleplon",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180105",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Centaur Pharmaceuticals Private Limited",
"SubstanceName": "ZALEPLON",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2026-08-27",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "18-FEB-18"
},
{
"NDCCode": "64330-054-29",
"PackageDescription": "29.7 kg in 1 DRUM (64330-054-29) ",
"NDC11Code": "64330-0054-29",
"ProductNDC": "64330-054",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zaleplon",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180105",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Centaur Pharmaceuticals Private Limited",
"SubstanceName": "ZALEPLON",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2026-08-27",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "18-FEB-18"
},
{
"NDCCode": "65219-054-29",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (65219-054-29) / 15 mL in 1 VIAL, SINGLE-DOSE (65219-054-09) ",
"NDC11Code": "65219-0054-29",
"ProductNDC": "65219-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212832",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200210",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates Injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
"Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "66343-054-50",
"PackageDescription": "50 mL in 1 BOTTLE (66343-054-50) ",
"NDC11Code": "66343-0054-50",
"ProductNDC": "66343-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emvita 5",
"NonProprietaryName": "Bufo Rana, Glandula Suprarenalis, Pulsatilla, Cuprum Metallicum, Phosphorus, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190603",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "RUBIMED AG",
"SubstanceName": "BUFO BUFO CUTANEOUS GLAND; SUS SCROFA ADRENAL GLAND; PULSATILLA VULGARIS; COPPER; PHOSPHORUS; ZINC",
"StrengthNumber": "800; 21; 16; 18; 21; 21",
"StrengthUnit": "[hp_C]/50mL; [hp_X]/50mL; [hp_M]/50mL; [hp_M]/50mL; [hp_X]/50mL; [hp_X]/50mL",
"Pharm_Classes": "Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-01-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190603",
"SamplePackage": "N"
},
{
"NDCCode": "68645-599-54",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68645-599-54) ",
"NDC11Code": "68645-0599-54",
"ProductNDC": "68645-599",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091497",
"LabelerName": "Legacy Pharmaceutical Packaging, LLC",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220808",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg, contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. Losartan potassium tablets USP, 25 mg and 50 mg meet USP Dissolution Test 1 and Losartan potassium tablets USP, 100 mg meet USP Dissolution Test 3."
},
{
"NDCCode": "69766-054-01",
"PackageDescription": "50 kg in 1 DRUM (69766-054-01) ",
"NDC11Code": "69766-0054-01",
"ProductNDC": "69766-054",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aminocaproic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180929",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "MSN Life Sciences Private Limited",
"SubstanceName": "AMINOCAPROIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-14",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "29-SEP-18"
}
]
}
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<ProductNDC>65131-054</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Broncochem</ProprietaryName>
<ProprietaryNameSuffix>Kids Cold And Flu</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen-phenylephrine Hcl-guaifenesin</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat.</IndicationAndUsage>
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<NDC>
<NDCCode>35192-054-18</NDCCode>
<PackageDescription>59 g in 1 JAR (35192-054-18) </PackageDescription>
<NDC11Code>35192-0054-18</NDC11Code>
<ProductNDC>35192-054</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sea-laminaria Kelp Day Cream Spf 30</ProprietaryName>
<NonProprietaryName>Sunscreen</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>CA-Botana International INC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply liberally 15 minutes before exposure, use waterresistant sunscreen, if swimming or sweating reaply at least every 2 hours Children under 6 months: ask a doctor.</IndicationAndUsage>
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<NDC>
<NDCCode>64330-054-35</NDCCode>
<PackageDescription>18 kg in 1 DRUM (64330-054-35) </PackageDescription>
<NDC11Code>64330-0054-35</NDC11Code>
<ProductNDC>64330-054</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zaleplon</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>ZALEPLON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2026-08-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-NOV-20</StartMarketingDatePackage>
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<NDC>
<NDCCode>64330-054-37</NDCCode>
<PackageDescription>18.5 kg in 1 DRUM (64330-054-37) </PackageDescription>
<NDC11Code>64330-0054-37</NDC11Code>
<ProductNDC>64330-054</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zaleplon</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>ZALEPLON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2026-08-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-JAN-21</StartMarketingDatePackage>
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<NDC>
<NDCCode>71919-822-18</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 KIT (71919-822-18) / 1 KIT in 1 VIAL, GLASS (71919-822-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 750 PELLET in 1 VIAL, GLASS (68428-069-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-064-01) * 750 PELLET in 1 VIAL, GLASS (71919-814-01) * 350 PELLET in 1 VIAL, GLASS (71919-770-01) * 750 PELLET in 1 VIAL, GLASS (68428-062-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-059-01) * 750 PELLET in 1 VIAL, GLASS (68428-058-01) * 750 PELLET in 1 VIAL, GLASS (68428-057-01) * 750 PELLET in 1 VIAL, GLASS (68428-056-01) * 350 PELLET in 1 VIAL, GLASS (71919-777-01) * 750 PELLET in 1 VIAL, GLASS (71919-813-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-053-01) * 750 PELLET in 1 VIAL, GLASS (68428-054-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 350 PELLET in 1 VIAL, GLASS (71919-763-01) * 750 PELLET in 1 VIAL, GLASS (68428-051-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-049-01) * 750 PELLET in 1 VIAL, GLASS (68428-048-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-041-01) * 750 PELLET in 1 VIAL, GLASS (68428-036-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-762-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-034-01) * 750 PELLET in 1 VIAL, GLASS (68428-040-01) * 750 PELLET in 1 VIAL, GLASS (68428-033-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (71919-812-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-026-01) </PackageDescription>
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<ProductNDC>71919-822</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>200c Homeopathic Remedy Kit</ProprietaryName>
<NonProprietaryName>50 Remedy Kit</NonProprietaryName>
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<StartMarketingDate>20240229</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts.</IndicationAndUsage>
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<NDC>
<NDCCode>72578-054-18</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (72578-054-18) </PackageDescription>
<NDC11Code>72578-0054-18</NDC11Code>
<ProductNDC>72578-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207774</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate capsules for oral administration. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrate. The structural formula of doxycycline hyclate is. Doxycycline hyclate, USP is yellow to light yellow powder. It is freely soluble in water and methanol, sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solution of alkali hydroxides and carbonates. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule contains doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg and inactive ingredients: anhydrous lactose, croscarmellose sodium, D&C red 28, FD & C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate and titanium dioxide. Each capsule cap is printed with white pharmaceutical ink and capsule body is printed with black pharmaceutical ink which contains following ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, and shellac. Additionally black pharmaceutical ink also contains black iron oxide.</Description>
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<NDC>
<NDCCode>0264-1915-00</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-1915-00) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER</PackageDescription>
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<ProductNDC>0264-1915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Procalamine</ProprietaryName>
<NonProprietaryName>Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite</NonProprietaryName>
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<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19820506</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018582</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE</SubstanceName>
<StrengthNumber>.21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2</StrengthNumber>
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<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
</NDC>
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<PackageDescription>6 CARTON in 1 CASE (0264-1915-07) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER</PackageDescription>
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<ProductNDC>0264-1915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Procalamine</ProprietaryName>
<NonProprietaryName>Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19820506</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018582</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE</SubstanceName>
<StrengthNumber>.21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2</StrengthNumber>
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<Pharm_Classes>Allergens [CS], Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>10544-054-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10544-054-30)</PackageDescription>
<NDC11Code>10544-0054-30</NDC11Code>
<ProductNDC>10544-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074342</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine and its structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored, and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>50090-3403-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-3403-0) </PackageDescription>
<NDC11Code>50090-3403-00</NDC11Code>
<ProductNDC>50090-3403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078232</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
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<NDCCode>50090-3403-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (50090-3403-1) </PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078232</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
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<NDCCode>50090-3403-2</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (50090-3403-2) </PackageDescription>
<NDC11Code>50090-3403-02</NDC11Code>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
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<NDCCode>50090-5480-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (50090-5480-0) </PackageDescription>
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<ApplicationNumber>ANDA078232</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
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<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
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<NDCCode>50090-5480-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-5480-1) </PackageDescription>
<NDC11Code>50090-5480-01</NDC11Code>
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<ApplicationNumber>ANDA078232</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
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<PackageDescription>100 TABLET in 1 BOTTLE (50090-5480-2) </PackageDescription>
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<LabelerName>A-S Medication Solutions</LabelerName>
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<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet USP is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and opadry white. The opadry white contains hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>50632-002-02</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (50632-002-02) / .5 mL in 1 VIAL (50632-002-01) </PackageDescription>
<NDC11Code>50632-0002-02</NDC11Code>
<ProductNDC>50632-002</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Jynneos</ProprietaryName>
<NonProprietaryName>Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250414</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125678</ApplicationNumber>
<LabelerName>Bavarian Nordic A/S</LabelerName>
<SubstanceName>VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN</SubstanceName>
<StrengthNumber>50000000</StrengthNumber>
<StrengthUnit>1/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.</IndicationAndUsage>
<Description>JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>50632-003-02</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (50632-003-02) / .65 mL in 1 VIAL (50632-003-01) </PackageDescription>
<NDC11Code>50632-0003-02</NDC11Code>
<ProductNDC>50632-003</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Diluent Component</ProprietaryName>
<NonProprietaryName>Water For Injection</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250414</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125678</ApplicationNumber>
<LabelerName>Bavarian Nordic A/S</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>.65</StrengthNumber>
<StrengthUnit>mL/.65mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.</IndicationAndUsage>
<Description>JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>50632-022-02</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (50632-022-02) / .5 mL in 1 VIAL (50632-022-04) </PackageDescription>
<NDC11Code>50632-0022-02</NDC11Code>
<ProductNDC>50632-022</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Jynneos</ProprietaryName>
<NonProprietaryName>Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125678</ApplicationNumber>
<LabelerName>Bavarian Nordic A/S</LabelerName>
<SubstanceName>VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN</SubstanceName>
<StrengthNumber>50000000</StrengthNumber>
<StrengthUnit>1/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.</IndicationAndUsage>
<Description>JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>50632-023-02</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50632-023-02) / .5 mL in 1 VIAL (50632-023-04) </PackageDescription>
<NDC11Code>50632-0023-02</NDC11Code>
<ProductNDC>50632-023</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Jynneos</ProprietaryName>
<NonProprietaryName>Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125678</ApplicationNumber>
<LabelerName>Bavarian Nordic A/S</LabelerName>
<SubstanceName>VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN</SubstanceName>
<StrengthNumber>50000000</StrengthNumber>
<StrengthUnit>1/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.</IndicationAndUsage>
<Description>JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>50632-024-02</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (50632-024-02) / .5 mL in 1 VIAL (50632-024-04) </PackageDescription>
<NDC11Code>50632-0024-02</NDC11Code>
<ProductNDC>50632-024</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Jynneos</ProprietaryName>
<NonProprietaryName>Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20251231</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125678</ApplicationNumber>
<LabelerName>Bavarian Nordic A/S</LabelerName>
<SubstanceName>VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN</SubstanceName>
<StrengthNumber>50000000</StrengthNumber>
<StrengthUnit>1/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.</IndicationAndUsage>
<Description>JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>64330-054-07</NDCCode>
<PackageDescription>5 kg in 1 DRUM (64330-054-07) </PackageDescription>
<NDC11Code>64330-0054-07</NDC11Code>
<ProductNDC>64330-054</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zaleplon</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>ZALEPLON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2026-08-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-JAN-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64330-054-12</NDCCode>
<PackageDescription>10 kg in 1 DRUM (64330-054-12) </PackageDescription>
<NDC11Code>64330-0054-12</NDC11Code>
<ProductNDC>64330-054</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zaleplon</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>ZALEPLON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2026-08-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-JAN-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64330-054-15</NDCCode>
<PackageDescription>25 kg in 1 DRUM (64330-054-15) </PackageDescription>
<NDC11Code>64330-0054-15</NDC11Code>
<ProductNDC>64330-054</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zaleplon</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>ZALEPLON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2026-08-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-SEP-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64330-054-27</NDCCode>
<PackageDescription>2.7 kg in 1 DRUM (64330-054-27) </PackageDescription>
<NDC11Code>64330-0054-27</NDC11Code>
<ProductNDC>64330-054</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zaleplon</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>ZALEPLON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2026-08-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-FEB-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64330-054-28</NDCCode>
<PackageDescription>2.15 kg in 1 DRUM (64330-054-28) </PackageDescription>
<NDC11Code>64330-0054-28</NDC11Code>
<ProductNDC>64330-054</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zaleplon</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>ZALEPLON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2026-08-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-FEB-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64330-054-29</NDCCode>
<PackageDescription>29.7 kg in 1 DRUM (64330-054-29) </PackageDescription>
<NDC11Code>64330-0054-29</NDC11Code>
<ProductNDC>64330-054</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zaleplon</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>ZALEPLON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2026-08-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-FEB-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65219-054-29</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (65219-054-29) / 15 mL in 1 VIAL, SINGLE-DOSE (65219-054-09) </PackageDescription>
<NDC11Code>65219-0054-29</NDC11Code>
<ProductNDC>65219-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212832</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates Injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .</IndicationAndUsage>
<Description>Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>66343-054-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (66343-054-50) </PackageDescription>
<NDC11Code>66343-0054-50</NDC11Code>
<ProductNDC>66343-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emvita 5</ProprietaryName>
<NonProprietaryName>Bufo Rana, Glandula Suprarenalis, Pulsatilla, Cuprum Metallicum, Phosphorus, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190603</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>RUBIMED AG</LabelerName>
<SubstanceName>BUFO BUFO CUTANEOUS GLAND; SUS SCROFA ADRENAL GLAND; PULSATILLA VULGARIS; COPPER; PHOSPHORUS; ZINC</SubstanceName>
<StrengthNumber>800; 21; 16; 18; 21; 21</StrengthNumber>
<StrengthUnit>[hp_C]/50mL; [hp_X]/50mL; [hp_M]/50mL; [hp_M]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
<Pharm_Classes>Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68645-599-54</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68645-599-54) </PackageDescription>
<NDC11Code>68645-0599-54</NDC11Code>
<ProductNDC>68645-599</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091497</ApplicationNumber>
<LabelerName>Legacy Pharmaceutical Packaging, LLC</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg, contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. Losartan potassium tablets USP, 25 mg and 50 mg meet USP Dissolution Test 1 and Losartan potassium tablets USP, 100 mg meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>69766-054-01</NDCCode>
<PackageDescription>50 kg in 1 DRUM (69766-054-01) </PackageDescription>
<NDC11Code>69766-0054-01</NDC11Code>
<ProductNDC>69766-054</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180929</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>MSN Life Sciences Private Limited</LabelerName>
<SubstanceName>AMINOCAPROIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-14</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-SEP-18</StartMarketingDatePackage>
</NDC>
</NDCList>