{
"NDC": [
{
"NDCCode": "0409-1941-01",
"PackageDescription": "5 TRAY in 1 CARTON (0409-1941-01) > 5 AMPULE in 1 TRAY > 1 mL in 1 AMPULE",
"NDC11Code": "00409-1941-01",
"ProductNDC": "0409-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talwin",
"NonProprietaryName": "Pentazocine Lactate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20051118",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016194",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "PENTAZOCINE LACTATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20051118",
"SamplePackage": "N"
},
{
"NDCCode": "0378-1941-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01) ",
"NDC11Code": "00378-1941-01",
"ProductNDC": "0378-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lenalidomide",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213912",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220906",
"SamplePackage": "N",
"IndicationAndUsage": "Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).",
"Description": "Lenalidomide capsules, a thalidomide analogue, are an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-Amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure. The molecular formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.27. Lenalidomide is an off-white to pale yellow powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/mL. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, microcrystalline cellulose, pregelatinized starch (corn), sodium stearyl fumarate and titanium dioxide. The 2.5 mg, 10 mg and 20 mg capsules also contain FD&C Blue No. 2 and yellow iron oxide. The 10 mg capsules also contain black iron oxide. The black imprinting ink for the 2.5 mg, 5 mg, 10 mg and 25 mg capsules contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The red imprinting ink for the 15 mg and 20 mg capsules contains ammonium hydroxide, propylene glycol, red iron oxide, shellac glaze and simethicone."
},
{
"NDCCode": "0781-1941-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-1941-01)",
"NDC11Code": "00781-1941-01",
"ProductNDC": "0781-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065212",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "36987-1941-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1941-1)",
"NDC11Code": "36987-1941-01",
"ProductNDC": "36987-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cladosporium Cladosporioides",
"NonProprietaryName": "Cladosporium Cladosporioides",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "CLADOSPORIUM CLADOSPORIOIDES",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-1941-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-1941-1) ",
"NDC11Code": "37662-1941-01",
"ProductNDC": "37662-1941",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rheum Officinale",
"NonProprietaryName": "Rheum Officinale",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221115",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "RHEUM OFFICINALE ROOT",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N"
},
{
"NDCCode": "43742-1941-1",
"PackageDescription": "960 mL in 1 BOTTLE, PLASTIC (43742-1941-1) ",
"NDC11Code": "43742-1941-01",
"ProductNDC": "43742-1941",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Mycoplasma Pneumoniae",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20210419",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "MYCOPLASMA PNEUMONIAE",
"StrengthNumber": "10",
"StrengthUnit": "[hp_M]/mL",
"Status": "Unfinished",
"LastUpdate": "2023-01-19",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19-APR-21"
},
{
"NDCCode": "58668-1941-1",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (58668-1941-1) > 30 mL in 1 BOTTLE",
"NDC11Code": "58668-1941-01",
"ProductNDC": "58668-1941",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clarins Broad Spectrum Spf 15 Sunscreen Extra-firming Foundation Tint 104",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100506",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laboratoires Clarins S.A.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-02-08",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63629-1941-1",
"PackageDescription": "473 mL in 1 BOTTLE (63629-1941-1) ",
"NDC11Code": "63629-1941-01",
"ProductNDC": "63629-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211023",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "325; 7.5",
"StrengthUnit": "mg/15mL; mg/15mL",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211221",
"SamplePackage": "N"
},
{
"NDCCode": "64942-1941-1",
"PackageDescription": "76 g in 1 CONTAINER (64942-1941-1) ",
"NDC11Code": "64942-1941-01",
"ProductNDC": "64942-1941",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Degree",
"NonProprietaryName": "Advanced Clean 72h Antiperspirant Deodorant",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210921",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Conopco Inc. d/b/a/ Unilever",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": "16",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210921",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "70518-1941-1",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-1941-1) ",
"NDC11Code": "70518-1941-01",
"ProductNDC": "70518-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209823",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N"
},
{
"NDCCode": "71335-1941-1",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (71335-1941-1) ",
"NDC11Code": "71335-1941-01",
"ProductNDC": "71335-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213474",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211229",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to Doxepin Hydrochloride Capsules, USP include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that Doxepin Hydrochloride Capsules, USP is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, Doxepin Hydrochloride Capsules, USP are not recommended for use in children under 12 years of age."
},
{
"NDCCode": "72162-1941-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (72162-1941-1) ",
"NDC11Code": "72162-1941-01",
"ProductNDC": "72162-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine Sulfate",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230831",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine Sulfate Orally Disintegrating Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Orally Disintegrating Tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Orally Disintegrating Tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:. Each tablet also contains as inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, mannitol, stearic acid, and FD&C blue #1, and D&C yellow #10."
},
{
"NDCCode": "0781-1941-31",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0781-1941-31) ",
"NDC11Code": "00781-1941-31",
"ProductNDC": "0781-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051114",
"EndMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065212",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20051114",
"EndMarketingDatePackage": "20200930",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1941-33",
"PackageDescription": "3 DOSE PACK in 1 CARTON (0781-1941-33) > 3 TABLET, FILM COATED in 1 DOSE PACK",
"NDC11Code": "00781-1941-33",
"ProductNDC": "0781-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051114",
"EndMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065212",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20051114",
"EndMarketingDatePackage": "20200930",
"SamplePackage": "N"
},
{
"NDCCode": "52584-360-01",
"PackageDescription": "1 VIAL, PLASTIC in 1 BAG (52584-360-01) > 10 mL in 1 VIAL, PLASTIC",
"NDC11Code": "52584-0360-01",
"ProductNDC": "52584-360",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Gluconate",
"NonProprietaryName": "Calcium Gluconate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180212",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208418",
"LabelerName": "General Injectables and Vaccines, Inc.",
"SubstanceName": "CALCIUM GLUCONATE MONOHYDRATE",
"StrengthNumber": "98",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180215",
"EndMarketingDatePackage": "20231130",
"SamplePackage": "N",
"IndicationAndUsage": "These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION.CALCIUM GLUCONATE injection, for intravenous useInitial U.S. Approval: 1941. Calcium Gluconate Injection is indicationd for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of Calcium Gluconate Injection for long term use has not been established.",
"Description": "Calcium Gluconate Injection, USP is a sterile, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O. Molecular weight: 448.39. Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial, or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of Calcium Gluconate Injection, USP contains 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of Calcium Gluconate Injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium."
},
{
"NDCCode": "0409-0001-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0409-0001-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-0001-01) ",
"NDC11Code": "00409-0001-25",
"ProductNDC": "0409-0001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midazolam",
"NonProprietaryName": "Midazolam Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20250127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075857",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250127",
"SamplePackage": "N",
"IndicationAndUsage": "Midazolam injection is indicated: 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;, 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;, 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);, 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.",
"Description": "Midazolam hydrochloride injection is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam compounded with 0.8% sodium chloride. The pH is adjusted to approximately 3 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C18H13ClFN3∙HCl, a calculated molecular weight of 362.25 and the following structural formula. Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed-ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 4.0 for the 1 mg/mL concentration and 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form."
},
{
"NDCCode": "0409-0007-10",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (0409-0007-10) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0007-01) ",
"NDC11Code": "00409-0007-10",
"ProductNDC": "0409-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089644",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
},
{
"NDCCode": "0409-0016-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0016-01) / 16 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-0016-01",
"ProductNDC": "0409-0016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220110",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous) and multiple-dose vials containing 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-0024-10",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0024-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-0024-01) ",
"NDC11Code": "00409-0024-10",
"ProductNDC": "0409-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sterile Water",
"NonProprietaryName": "Water",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018801",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "1",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.",
"Description": "This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. For I.V. injection, add sufficient solute to make an approximately isotonic solution. Water for Injection, USP is chemically designated H2O. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper labeled volume."
},
{
"NDCCode": "0409-0025-10",
"PackageDescription": "12 POUCH in 1 CASE (0409-0025-10) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0025-01) ",
"NDC11Code": "00409-0025-10",
"ProductNDC": "0409-0025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dobutamine In Dextrose",
"NonProprietaryName": "Dobutamine In Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020201",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260316",
"SamplePackage": "N",
"IndicationAndUsage": "Dobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.",
"Description": "Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 2.5 to 5.5. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive. Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "0409-0032-01",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0032-01) / 15 mL in 1 VIAL, SINGLE-DOSE (0409-0032-10) ",
"NDC11Code": "00409-0032-01",
"ProductNDC": "0409-0032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217459",
"LabelerName": "Hospira, Inc.",
"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": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250929",
"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 15 mL single-dose vials. 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": "0409-0042-12",
"PackageDescription": "12 POUCH in 1 CASE (0409-0042-12) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0042-01) ",
"NDC11Code": "00409-0042-12",
"ProductNDC": "0409-0042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dopamine Hydrochloride In Dextrose",
"NonProprietaryName": "Dopamine Hydrochloride In Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018826",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOPAMINE HYDROCHLORIDE",
"StrengthNumber": "1.6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251103",
"SamplePackage": "N",
"IndicationAndUsage": "Dopamine Hydrochloride in Dextrose Injection is indicated to improve hemodynamic status in patients in distributive shock, or shock due to reduced cardiac output.",
"Description": "Dopamine Hydrochloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, premixed solution of dopamine hydrochloride in 5% dextrose injection for intravenous infusion. Each 100 mL contains 160 mg (1,600 mcg/mL) or 320 mg (3,200 mcg/mL) of dopamine HCl; 5 grams of hydrous dextrose, in Water for Injection, and 50 mg of sodium metabisulfite (a stabilizer); pH = 2.5 to 4.5, and the following osmolar concentrations: 269, or 286 mOsmol/liter, respectively. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dopamine HCl is chemically designated 3, 4-dihydroxyphenethylamine hydrochloride (C8H11NO2 ∙ HCl), a white crystalline powder freely soluble in water. Dopamine HCl has a molecular weight of 189.64 and it has the following structural formula. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring endogenous catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17 and it has the following structural formula. Water for Injection, USP is chemically designated H2O."
},
{
"NDCCode": "0409-0106-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0106-01) > 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0106-01",
"ProductNDC": "0409-0106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daptomycin",
"NonProprietaryName": "Daptomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202857",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DAPTOMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Lipopeptide Antibacterial [EPC],Lipopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170104",
"SamplePackage": "N"
},
{
"NDCCode": "0409-0120-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0120-01) / 7 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0120-01",
"ProductNDC": "0409-0120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daptomycin",
"NonProprietaryName": "Daptomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210802",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210282",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DAPTOMYCIN",
"StrengthNumber": "350",
"StrengthUnit": "mg/7mL",
"Pharm_Classes": "Lipopeptide Antibacterial [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210802",
"SamplePackage": "N",
"IndicationAndUsage": "Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult patients (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2).",
"Description": "Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L‑threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1‑ lactone. The chemical structure is. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.5)]. Daptomycin for Injection 350 mg per vial, contains 350 mg daptomycin and 53.8 mg citric acid. Sodium hydroxide is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, and 76.8 mg citric acid. Sodium hydroxide is used to adjust the pH. Freshly reconstituted solutions of Daptomycin for Injection range in color from light yellow to light brown."
},
{
"NDCCode": "0409-0122-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0122-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0122-01",
"ProductNDC": "0409-0122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daptomycin",
"NonProprietaryName": "Daptomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210802",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210282",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DAPTOMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Lipopeptide Antibacterial [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210802",
"SamplePackage": "N",
"IndicationAndUsage": "Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult patients (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2).",
"Description": "Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L‑threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1‑ lactone. The chemical structure is. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.5)]. Daptomycin for Injection 350 mg per vial, contains 350 mg daptomycin and 53.8 mg citric acid. Sodium hydroxide is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, and 76.8 mg citric acid. Sodium hydroxide is used to adjust the pH. Freshly reconstituted solutions of Daptomycin for Injection range in color from light yellow to light brown."
},
{
"NDCCode": "0409-0124-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0409-0124-01) > 25 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00409-0124-01",
"ProductNDC": "0409-0124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAVENOUS; INTRAVESICAL",
"StartMarketingDate": "20160418",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0409-0125-25",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01) ",
"NDC11Code": "00409-0125-25",
"ProductNDC": "0409-0125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075240",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230807",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.",
"Description": "Labetalol hydrochloride is an adrenergic receptor blocking agent that has both selective alpha1- and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate, chemically designated as 5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl]-salicylamide monohydrochloride, and has the following structural formula. Labetalol hydrochloride has the molecular formula C19H24N2O3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range."
},
{
"NDCCode": "0409-0147-10",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (0409-0147-10) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0147-01) ",
"NDC11Code": "00409-0147-10",
"ProductNDC": "0409-0147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089646",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "20; 10",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
},
{
"NDCCode": "0409-0151-10",
"PackageDescription": "12 POUCH in 1 CASE (0409-0151-10) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0151-01) ",
"NDC11Code": "00409-0151-10",
"ProductNDC": "0409-0151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dobutamine In Dextrose",
"NonProprietaryName": "Dobutamine In Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020201",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260316",
"SamplePackage": "N",
"IndicationAndUsage": "Dobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.",
"Description": "Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 2.5 to 5.5. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive. Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "0409-0152-24",
"PackageDescription": "24 POUCH in 1 CARTON (0409-0152-24) / 1 BAG in 1 POUCH (0409-0152-01) / 100 mL in 1 BAG",
"NDC11Code": "00409-0152-24",
"ProductNDC": "0409-0152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20211213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206191",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211213",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection and other antibacterial drugs, Metronidazole Injection 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": "Metronidazole Injection, USP is a sterile, parenteral dosage form of metronidazole in water. Each 100 mL of Metronidazole Injection, USP contains a sterile, nonpyrogenic, isotonic, buffered solution of Metronidazole, USP 500 mg, Sodium Chloride, USP 740 mg, Dibasic Sodium Phosphate Dihydrate, USP 75 mg and Citric Acid Anhydrous, USP 40 mg in Water for Injection, USP. Metronidazole Injection, USP has a calculated osmolality from 270 to 310 mOsmol/kg and a pH from 4.5 to 6.0. Sodium content: 13.5 mEq/container. Metronidazole is classified as a nitroimidazole antimicrobial and is administered by the intravenous route. Metronidazole, USP is chemically designated 2-methyl-5-nitroimidazole-1-ethanol (C6H9N3O3):. Not made with natural rubber latex. The flexible container is fabricated from a specially formulated non-plasticized, thermoplastic copolyolephine. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0409-1941-01</NDCCode>
<PackageDescription>5 TRAY in 1 CARTON (0409-1941-01) > 5 AMPULE in 1 TRAY > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00409-1941-01</NDC11Code>
<ProductNDC>0409-1941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Talwin</ProprietaryName>
<NonProprietaryName>Pentazocine Lactate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20051118</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016194</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>PENTAZOCINE LACTATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-1941-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01) </PackageDescription>
<NDC11Code>00378-1941-01</NDC11Code>
<ProductNDC>0378-1941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lenalidomide</ProprietaryName>
<NonProprietaryName>Lenalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213912</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LENALIDOMIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).</IndicationAndUsage>
<Description>Lenalidomide capsules, a thalidomide analogue, are an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-Amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure. The molecular formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.27. Lenalidomide is an off-white to pale yellow powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/mL. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, microcrystalline cellulose, pregelatinized starch (corn), sodium stearyl fumarate and titanium dioxide. The 2.5 mg, 10 mg and 20 mg capsules also contain FD&C Blue No. 2 and yellow iron oxide. The 10 mg capsules also contain black iron oxide. The black imprinting ink for the 2.5 mg, 5 mg, 10 mg and 25 mg capsules contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The red imprinting ink for the 15 mg and 20 mg capsules contains ammonium hydroxide, propylene glycol, red iron oxide, shellac glaze and simethicone.</Description>
</NDC>
<NDC>
<NDCCode>0781-1941-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0781-1941-01)</PackageDescription>
<NDC11Code>00781-1941-01</NDC11Code>
<ProductNDC>0781-1941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065212</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>36987-1941-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1941-1)</PackageDescription>
<NDC11Code>36987-1941-01</NDC11Code>
<ProductNDC>36987-1941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cladosporium Cladosporioides</ProprietaryName>
<NonProprietaryName>Cladosporium Cladosporioides</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>CLADOSPORIUM CLADOSPORIOIDES</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-1941-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-1941-1) </PackageDescription>
<NDC11Code>37662-1941-01</NDC11Code>
<ProductNDC>37662-1941</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rheum Officinale</ProprietaryName>
<NonProprietaryName>Rheum Officinale</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221115</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>RHEUM OFFICINALE ROOT</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43742-1941-1</NDCCode>
<PackageDescription>960 mL in 1 BOTTLE, PLASTIC (43742-1941-1) </PackageDescription>
<NDC11Code>43742-1941-01</NDC11Code>
<ProductNDC>43742-1941</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Mycoplasma Pneumoniae</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20210419</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>MYCOPLASMA PNEUMONIAE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>[hp_M]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-01-19</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19-APR-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>58668-1941-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (58668-1941-1) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58668-1941-01</NDC11Code>
<ProductNDC>58668-1941</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clarins Broad Spectrum Spf 15 Sunscreen Extra-firming Foundation Tint 104</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100506</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laboratoires Clarins S.A.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-08</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63629-1941-1</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (63629-1941-1) </PackageDescription>
<NDC11Code>63629-1941-01</NDC11Code>
<ProductNDC>63629-1941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211023</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>325; 7.5</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64942-1941-1</NDCCode>
<PackageDescription>76 g in 1 CONTAINER (64942-1941-1) </PackageDescription>
<NDC11Code>64942-1941-01</NDC11Code>
<ProductNDC>64942-1941</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Degree</ProprietaryName>
<NonProprietaryName>Advanced Clean 72h Antiperspirant Deodorant</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210921</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a/ Unilever</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70518-1941-1</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70518-1941-1) </PackageDescription>
<NDC11Code>70518-1941-01</NDC11Code>
<ProductNDC>70518-1941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190308</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209823</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-1941-1</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (71335-1941-1) </PackageDescription>
<NDC11Code>71335-1941-01</NDC11Code>
<ProductNDC>71335-1941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213474</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to Doxepin Hydrochloride Capsules, USP include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that Doxepin Hydrochloride Capsules, USP is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, Doxepin Hydrochloride Capsules, USP are not recommended for use in children under 12 years of age.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72162-1941-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72162-1941-1) </PackageDescription>
<NDC11Code>72162-1941-01</NDC11Code>
<ProductNDC>72162-1941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine Sulfate Orally Disintegrating Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Orally Disintegrating Tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Orally Disintegrating Tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:. Each tablet also contains as inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, mannitol, stearic acid, and FD&C blue #1, and D&C yellow #10.</Description>
</NDC>
<NDC>
<NDCCode>0781-1941-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0781-1941-31) </PackageDescription>
<NDC11Code>00781-1941-31</NDC11Code>
<ProductNDC>0781-1941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051114</StartMarketingDate>
<EndMarketingDate>20200930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065212</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20051114</StartMarketingDatePackage>
<EndMarketingDatePackage>20200930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1941-33</NDCCode>
<PackageDescription>3 DOSE PACK in 1 CARTON (0781-1941-33) > 3 TABLET, FILM COATED in 1 DOSE PACK</PackageDescription>
<NDC11Code>00781-1941-33</NDC11Code>
<ProductNDC>0781-1941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051114</StartMarketingDate>
<EndMarketingDate>20200930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065212</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20051114</StartMarketingDatePackage>
<EndMarketingDatePackage>20200930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52584-360-01</NDCCode>
<PackageDescription>1 VIAL, PLASTIC in 1 BAG (52584-360-01) > 10 mL in 1 VIAL, PLASTIC</PackageDescription>
<NDC11Code>52584-0360-01</NDC11Code>
<ProductNDC>52584-360</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Gluconate</ProprietaryName>
<NonProprietaryName>Calcium Gluconate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180212</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208418</ApplicationNumber>
<LabelerName>General Injectables and Vaccines, Inc.</LabelerName>
<SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
<StrengthNumber>98</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180215</StartMarketingDatePackage>
<EndMarketingDatePackage>20231130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION.CALCIUM GLUCONATE injection, for intravenous useInitial U.S. Approval: 1941. Calcium Gluconate Injection is indicationd for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of Calcium Gluconate Injection for long term use has not been established.</IndicationAndUsage>
<Description>Calcium Gluconate Injection, USP is a sterile, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O. Molecular weight: 448.39. Solubility in water: 3.5 g/100 mL at 25°C. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial, or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of Calcium Gluconate Injection, USP contains 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of Calcium Gluconate Injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium.</Description>
</NDC>
<NDC>
<NDCCode>0409-0001-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0409-0001-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-0001-01) </PackageDescription>
<NDC11Code>00409-0001-25</NDC11Code>
<ProductNDC>0409-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midazolam</ProprietaryName>
<NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20250127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075857</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midazolam injection is indicated: 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;, 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;, 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);, 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.</IndicationAndUsage>
<Description>Midazolam hydrochloride injection is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam compounded with 0.8% sodium chloride. The pH is adjusted to approximately 3 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C18H13ClFN3∙HCl, a calculated molecular weight of 362.25 and the following structural formula. Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed-ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 4.0 for the 1 mg/mL concentration and 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form.</Description>
</NDC>
<NDC>
<NDCCode>0409-0007-10</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0409-0007-10) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0007-01) </PackageDescription>
<NDC11Code>00409-0007-10</NDC11Code>
<ProductNDC>0409-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089644</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0409-0016-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-0016-01) / 16 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00409-0016-01</NDC11Code>
<ProductNDC>0409-0016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220110</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022234</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous) and multiple-dose vials containing 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>0409-0024-10</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0024-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-0024-01) </PackageDescription>
<NDC11Code>00409-0024-10</NDC11Code>
<ProductNDC>0409-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sterile Water</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250331</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018801</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.</IndicationAndUsage>
<Description>This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. For I.V. injection, add sufficient solute to make an approximately isotonic solution. Water for Injection, USP is chemically designated H2O. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper labeled volume.</Description>
</NDC>
<NDC>
<NDCCode>0409-0025-10</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-0025-10) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0025-01) </PackageDescription>
<NDC11Code>00409-0025-10</NDC11Code>
<ProductNDC>0409-0025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dobutamine In Dextrose</ProprietaryName>
<NonProprietaryName>Dobutamine In Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020201</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
<Description>Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 2.5 to 5.5. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive. Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>0409-0032-01</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0032-01) / 15 mL in 1 VIAL, SINGLE-DOSE (0409-0032-10) </PackageDescription>
<NDC11Code>00409-0032-01</NDC11Code>
<ProductNDC>0409-0032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217459</ApplicationNumber>
<LabelerName>Hospira, Inc.</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>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250929</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 15 mL single-dose vials. 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>0409-0042-12</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-0042-12) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0042-01) </PackageDescription>
<NDC11Code>00409-0042-12</NDC11Code>
<ProductNDC>0409-0042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dopamine Hydrochloride In Dextrose</ProprietaryName>
<NonProprietaryName>Dopamine Hydrochloride In Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251103</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018826</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOPAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dopamine Hydrochloride in Dextrose Injection is indicated to improve hemodynamic status in patients in distributive shock, or shock due to reduced cardiac output.</IndicationAndUsage>
<Description>Dopamine Hydrochloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, premixed solution of dopamine hydrochloride in 5% dextrose injection for intravenous infusion. Each 100 mL contains 160 mg (1,600 mcg/mL) or 320 mg (3,200 mcg/mL) of dopamine HCl; 5 grams of hydrous dextrose, in Water for Injection, and 50 mg of sodium metabisulfite (a stabilizer); pH = 2.5 to 4.5, and the following osmolar concentrations: 269, or 286 mOsmol/liter, respectively. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dopamine HCl is chemically designated 3, 4-dihydroxyphenethylamine hydrochloride (C8H11NO2 ∙ HCl), a white crystalline powder freely soluble in water. Dopamine HCl has a molecular weight of 189.64 and it has the following structural formula. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring endogenous catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17 and it has the following structural formula. Water for Injection, USP is chemically designated H2O.</Description>
</NDC>
<NDC>
<NDCCode>0409-0106-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0106-01) > 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0106-01</NDC11Code>
<ProductNDC>0409-0106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daptomycin</ProprietaryName>
<NonProprietaryName>Daptomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202857</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DAPTOMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Lipopeptide Antibacterial [EPC],Lipopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-0120-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0120-01) / 7 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0120-01</NDC11Code>
<ProductNDC>0409-0120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daptomycin</ProprietaryName>
<NonProprietaryName>Daptomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210802</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210282</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DAPTOMYCIN</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/7mL</StrengthUnit>
<Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult patients (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2).</IndicationAndUsage>
<Description>Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L‑threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1‑ lactone. The chemical structure is. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.5)]. Daptomycin for Injection 350 mg per vial, contains 350 mg daptomycin and 53.8 mg citric acid. Sodium hydroxide is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, and 76.8 mg citric acid. Sodium hydroxide is used to adjust the pH. Freshly reconstituted solutions of Daptomycin for Injection range in color from light yellow to light brown.</Description>
</NDC>
<NDC>
<NDCCode>0409-0122-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0122-01) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0122-01</NDC11Code>
<ProductNDC>0409-0122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daptomycin</ProprietaryName>
<NonProprietaryName>Daptomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210802</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210282</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DAPTOMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult patients (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2).</IndicationAndUsage>
<Description>Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L‑threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1‑ lactone. The chemical structure is. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.5)]. Daptomycin for Injection 350 mg per vial, contains 350 mg daptomycin and 53.8 mg citric acid. Sodium hydroxide is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, and 76.8 mg citric acid. Sodium hydroxide is used to adjust the pH. Freshly reconstituted solutions of Daptomycin for Injection range in color from light yellow to light brown.</Description>
</NDC>
<NDC>
<NDCCode>0409-0124-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0409-0124-01) > 25 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00409-0124-01</NDC11Code>
<ProductNDC>0409-0124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAVENOUS; INTRAVESICAL</RouteName>
<StartMarketingDate>20160418</StartMarketingDate>
<EndMarketingDate>20171231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-0125-25</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01) </PackageDescription>
<NDC11Code>00409-0125-25</NDC11Code>
<ProductNDC>0409-0125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075240</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.</IndicationAndUsage>
<Description>Labetalol hydrochloride is an adrenergic receptor blocking agent that has both selective alpha1- and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate, chemically designated as 5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl]-salicylamide monohydrochloride, and has the following structural formula. Labetalol hydrochloride has the molecular formula C19H24N2O3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range.</Description>
</NDC>
<NDC>
<NDCCode>0409-0147-10</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0409-0147-10) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0147-01) </PackageDescription>
<NDC11Code>00409-0147-10</NDC11Code>
<ProductNDC>0409-0147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089646</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
<StrengthNumber>20; 10</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0409-0151-10</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-0151-10) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0151-01) </PackageDescription>
<NDC11Code>00409-0151-10</NDC11Code>
<ProductNDC>0409-0151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dobutamine In Dextrose</ProprietaryName>
<NonProprietaryName>Dobutamine In Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020201</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
<Description>Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 2.5 to 5.5. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive. Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>0409-0152-24</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (0409-0152-24) / 1 BAG in 1 POUCH (0409-0152-01) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-0152-24</NDC11Code>
<ProductNDC>0409-0152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206191</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection and other antibacterial drugs, Metronidazole Injection 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>Metronidazole Injection, USP is a sterile, parenteral dosage form of metronidazole in water. Each 100 mL of Metronidazole Injection, USP contains a sterile, nonpyrogenic, isotonic, buffered solution of Metronidazole, USP 500 mg, Sodium Chloride, USP 740 mg, Dibasic Sodium Phosphate Dihydrate, USP 75 mg and Citric Acid Anhydrous, USP 40 mg in Water for Injection, USP. Metronidazole Injection, USP has a calculated osmolality from 270 to 310 mOsmol/kg and a pH from 4.5 to 6.0. Sodium content: 13.5 mEq/container. Metronidazole is classified as a nitroimidazole antimicrobial and is administered by the intravenous route. Metronidazole, USP is chemically designated 2-methyl-5-nitroimidazole-1-ethanol (C6H9N3O3):. Not made with natural rubber latex. The flexible container is fabricated from a specially formulated non-plasticized, thermoplastic copolyolephine. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
</NDCList>