{
"NDC": [
{
"NDCCode": "0409-3375-25",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3375-25) > 4 mL in 1 VIAL, SINGLE-DOSE (0409-3375-35) ",
"NDC11Code": "00409-3375-25",
"ProductNDC": "0409-3375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levophed",
"NonProprietaryName": "Norepinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA007513",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "NOREPINEPHRINE BITARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130628",
"SamplePackage": "N"
},
{
"NDCCode": "0409-3375-04",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3375-04) / 4 mL in 1 VIAL, SINGLE-DOSE (0409-3375-14) ",
"NDC11Code": "00409-3375-04",
"ProductNDC": "0409-3375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levophed",
"NonProprietaryName": "Norepinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA007513",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "NOREPINEPHRINE BITARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090427",
"SamplePackage": "N",
"IndicationAndUsage": "LEVOPHED is indicated to raise blood pressure in adult patients with severe, acute hypotension.",
"Description": "Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. LEVOPHED is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula. LEVOPHED is supplied in a sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains 1 mg of norepinephrine base (equivalent to 1.89 mg of norepinephrine bitartrate, anhydrous basis), sodium chloride for isotonicity, not more than 0.2 mg (vials) or 2 mg (ampules) of sodium metabisulfite as an antioxidant. It has a pH of 3.0 to 4.5. The air in the containers has been displaced by nitrogen gas."
},
{
"NDCCode": "38779-3375-4",
"PackageDescription": "25 g in 1 BOTTLE (38779-3375-4) ",
"NDC11Code": "38779-3375-04",
"ProductNDC": "38779-3375",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260527",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-06-05",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "27-MAY-26"
},
{
"NDCCode": "68071-3375-1",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68071-3375-1) ",
"NDC11Code": "68071-3375-01",
"ProductNDC": "68071-3375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203512",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170711",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are indicated in the management of. Primary hyperaldosteronism for:. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:.",
"Description": "Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths."
},
{
"NDCCode": "68071-3375-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68071-3375-3) ",
"NDC11Code": "68071-3375-03",
"ProductNDC": "68071-3375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203512",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170711",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are indicated in the management of. Primary hyperaldosteronism for:. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:.",
"Description": "Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths."
},
{
"NDCCode": "68071-3375-6",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68071-3375-6) ",
"NDC11Code": "68071-3375-06",
"ProductNDC": "68071-3375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203512",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170711",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are indicated in the management of. Primary hyperaldosteronism for:. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:.",
"Description": "Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths."
},
{
"NDCCode": "68071-3375-8",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (68071-3375-8) ",
"NDC11Code": "68071-3375-08",
"ProductNDC": "68071-3375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203512",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170711",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are indicated in the management of. Primary hyperaldosteronism for:. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:.",
"Description": "Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths."
},
{
"NDCCode": "68071-3375-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68071-3375-9) ",
"NDC11Code": "68071-3375-09",
"ProductNDC": "68071-3375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203512",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170711",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are indicated in the management of. Primary hyperaldosteronism for:. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:.",
"Description": "Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths."
},
{
"NDCCode": "83021-551-50",
"PackageDescription": "50 mL in 1 BOTTLE (83021-551-50) ",
"NDC11Code": "83021-0551-50",
"ProductNDC": "83021-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubismed",
"NonProprietaryName": "Spf 50 Broad Spectrum Protection Fluid Emulsion",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221015",
"EndMarketingDate": "20270429",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; GLYCERIN; LINOLENIC ACID; TROMETHAMINE; OCTOCRYLENE; BUTYLATED HYDROXYTOLUENE; PROPYLENE GLYCOL; WATER; FRAGRANCE 13576; CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED); .ALPHA.-TOCOPHEROL; POLY(METHYL METHACRYLATE; 450000 MW); AVOBENZONE; TITANIUM DIOXIDE; PHENOXYETHANOL; POLYETHYLENE GLYCOL 400; LINOLEIC ACID; SILICON DIOXIDE; ANHYDROUS CITRIC ACID; ASCORBYL PALMITATE; ASCORBIC ACID; OCTISALATE; BEMOTRIZINOL; DIMETHICONE; OCTINOXATE; BUTYLENE GLYCOL; C20-22 ALCOHOLS; CHLORPHENESIN",
"StrengthNumber": ".025; .005; .00275; .22; 1.8; .0018; 2.5; 27.55; .3; .075; .006; 2.1; 1.8; .425; .35; .14225; .49725; .575; .00025; .00125; .00025; 1.8; 1.45; 1.25; 3.5982; 2.5; .3375; .1",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL",
"Pharm_Classes": "Acidifying Activity [MoA], Allergens [CS], Anti-coagulant [EPC], Ascorbic Acid [CS], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221015",
"EndMarketingDatePackage": "20270429",
"SamplePackage": "N"
},
{
"NDCCode": "83021-686-50",
"PackageDescription": "50 mL in 1 BOTTLE (83021-686-50) ",
"NDC11Code": "83021-0686-50",
"ProductNDC": "83021-686",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Protective Line",
"NonProprietaryName": "Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221102",
"EndMarketingDate": "20280309",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; CHLORPHENESIN; OCTISALATE; BUTYLENE GLYCOL; PROPYLENE GLYCOL; POLY(METHYL METHACRYLATE; 450000 MW); WATER; SILICON DIOXIDE; BUTYLATED HYDROXYTOLUENE; DIMETHICONE; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; C20-22 ALCOHOLS; FRAGRANCE 13576; CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED); TROMETHAMINE; BEMOTRIZINOL; POLYETHYLENE GLYCOL 400; ASCORBYL PALMITATE; PHENOXYETHANOL; OCTOCRYLENE; AVOBENZONE; LINOLENIC ACID; ASCORBIC ACID; TOCOPHEROL; LINOLEIC ACID; GLYCERIN",
"StrengthNumber": "3.5982; .425; .1; 1.8; 2.5; 2.5; 2.1; 27.55; .575; .0018; 1.25; .025; .3375; .3; .075; .22; 1.45; .14225; .00125; .35; 1.8; 1.8; .00275; .00025; .006; .49725; .005",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL",
"Pharm_Classes": "Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221102",
"EndMarketingDatePackage": "20280309",
"SamplePackage": "N"
},
{
"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": "0409-0009-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0009-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-0009-02) ",
"NDC11Code": "00409-0009-25",
"ProductNDC": "0409-0009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20241216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077548",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241216",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1), 2 postoperative nausea and/or vomiting. (1.2).",
"Description": "The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9‑ tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3O∙HCl∙2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution in the 2-mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.46 mg of citric acid anhydrous, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0."
},
{
"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": "0409-0032-01",
"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": "0409-0124-01",
"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": "2026-07-17",
"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": "0409-0181-25",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0181-25) / 26.3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0181-25",
"ProductNDC": "0409-0181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemcitabine",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130709",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200795",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130709",
"SamplePackage": "N",
"IndicationAndUsage": "Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).",
"Description": "Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine HCl is a white to off-white solid with a molecular formula of C9H11F2N3O4 ∙HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.7 mg, 1.139 g, or 2.227 g of gemcitabine HCl. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.27 mg of gemcitabine HCl. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
},
{
"NDCCode": "0409-0182-25",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0182-25) / 52.6 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0182-25",
"ProductNDC": "0409-0182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemcitabine",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130729",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200795",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130729",
"SamplePackage": "N",
"IndicationAndUsage": "Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).",
"Description": "Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine HCl is a white to off-white solid with a molecular formula of C9H11F2N3O4 ∙HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.7 mg, 1.139 g, or 2.227 g of gemcitabine HCl. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.27 mg of gemcitabine HCl. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
},
{
"NDCCode": "0409-0183-25",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0183-25) / 5.26 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0183-25",
"ProductNDC": "0409-0183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemcitabine",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130709",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200795",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130709",
"SamplePackage": "N",
"IndicationAndUsage": "Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).",
"Description": "Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine HCl is a white to off-white solid with a molecular formula of C9H11F2N3O4 ∙HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.7 mg, 1.139 g, or 2.227 g of gemcitabine HCl. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.27 mg of gemcitabine HCl. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
},
{
"NDCCode": "0409-0186-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0186-01) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0186-01",
"ProductNDC": "0409-0186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemcitabine",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078339",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110726",
"SamplePackage": "N",
"IndicationAndUsage": "Gemcitabine is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).",
"Description": "Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer) with the following structural formula. The empirical formula for gemcitabine hydrochloride is C9H11F2N3O4 ∙ HCl. It has a molecular weight of 299.66 g/mol. Gemcitabine hydrochloride is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine hydrochloride is a sterile white to off-white lyophilized powder and available as 200 mg and 1 g single-dose vials for intravenous use only. Each 200 mg vial contains 200 mg gemcitabine (equivalent to 227.7 mg gemcitabine hydrochloride), 200 mg mannitol and 12.5 mg sodium acetate. Each 1 g vial contains 1 g gemcitabine (equivalent to 1.139 g gemcitabine hydrochloride), 1 g mannitol, and 62.5 mg sodium acetate. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
},
{
"NDCCode": "0409-0201-25",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0409-0201-25) > 2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00409-0201-25",
"ProductNDC": "0409-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130909",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-03-07"
},
{
"NDCCode": "0409-0217-01",
"PackageDescription": "25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON (0409-0217-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-0217-11) ",
"NDC11Code": "00409-0217-01",
"ProductNDC": "0409-0217",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maxipime",
"NonProprietaryName": "Cefepime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130218",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050679",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CEFEPIME HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130218",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "0409-0218-01",
"PackageDescription": "25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON (0409-0218-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-0218-11) ",
"NDC11Code": "00409-0218-01",
"ProductNDC": "0409-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maxipime",
"NonProprietaryName": "Cefepime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050679",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CEFEPIME HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130218",
"SamplePackage": "N"
},
{
"NDCCode": "0409-0302-25",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0409-0302-25) > 4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00409-0302-25",
"ProductNDC": "0409-0302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topotecan",
"NonProprietaryName": "Topotecan",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130924",
"EndMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200582",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "TOPOTECAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130924",
"EndMarketingDatePackage": "20180131",
"SamplePackage": "N"
},
{
"NDCCode": "0409-0525-25",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-0525-25) / 50 mL in 1 VIAL, MULTI-DOSE (0409-0525-01) ",
"NDC11Code": "00409-0525-25",
"ProductNDC": "0409-0525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Marcaine",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERINEURAL",
"StartMarketingDate": "20241209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016964",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241209",
"SamplePackage": "N",
"IndicationAndUsage": "MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults 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 MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula. MARCAINE (bupivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. MARCAINE with epinephrine 1:200,000 (as bitartrate) is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.0091 mg epinephrine bitartrate (equivalent to 0.005 mg of epinephrine), with sodium chloride for isotonicity, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008."
},
{
"NDCCode": "0409-0528-25",
"PackageDescription": "24 POUCH in 1 CASE (0409-0528-25) / 1 BAG in 1 POUCH / 100 mL in 1 BAG (0409-0528-23) ",
"NDC11Code": "00409-0528-25",
"ProductNDC": "0409-0528",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078579",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170612",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin Injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. The empirical formula is C18H20FN3O4 ∙ ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2."
},
{
"NDCCode": "0409-0802-01",
"PackageDescription": "25 VIAL in 1 CARTON (0409-0802-01) > 16.7 mL in 1 VIAL",
"NDC11Code": "00409-0802-01",
"ProductNDC": "0409-0802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime",
"NonProprietaryName": "Cefuroxime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065503",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CEFUROXIME SODIUM",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0409-0805-01",
"PackageDescription": "25 VIAL in 1 CARTON (0409-0805-01) > 3 mL in 1 VIAL (0409-0805-11) ",
"NDC11Code": "00409-0805-01",
"ProductNDC": "0409-0805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefazolin",
"NonProprietaryName": "Cefazolin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065226",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CEFAZOLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/3mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090327",
"SamplePackage": "N"
},
{
"NDCCode": "0409-0805-02",
"PackageDescription": "25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON (0409-0805-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-0805-12)",
"NDC11Code": "00409-0805-02",
"ProductNDC": "0409-0805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefazolin",
"NonProprietaryName": "Cefazolin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201654",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CEFAZOLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "0409-0805-50",
"PackageDescription": "25 VIAL in 1 CARTON (0409-0805-50) > 3 mL in 1 VIAL",
"NDC11Code": "00409-0805-50",
"ProductNDC": "0409-0805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefazolin",
"NonProprietaryName": "Cefazolin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20090324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065226",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CEFAZOLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/3mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-09-19"
}
]
}
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<NDCList>
<NDC>
<NDCCode>0409-3375-25</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3375-25) > 4 mL in 1 VIAL, SINGLE-DOSE (0409-3375-35) </PackageDescription>
<NDC11Code>00409-3375-25</NDC11Code>
<ProductNDC>0409-3375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levophed</ProprietaryName>
<NonProprietaryName>Norepinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA007513</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>NOREPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-3375-04</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3375-04) / 4 mL in 1 VIAL, SINGLE-DOSE (0409-3375-14) </PackageDescription>
<NDC11Code>00409-3375-04</NDC11Code>
<ProductNDC>0409-3375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levophed</ProprietaryName>
<NonProprietaryName>Norepinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA007513</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>NOREPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LEVOPHED is indicated to raise blood pressure in adult patients with severe, acute hypotension.</IndicationAndUsage>
<Description>Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. LEVOPHED is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula. LEVOPHED is supplied in a sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains 1 mg of norepinephrine base (equivalent to 1.89 mg of norepinephrine bitartrate, anhydrous basis), sodium chloride for isotonicity, not more than 0.2 mg (vials) or 2 mg (ampules) of sodium metabisulfite as an antioxidant. It has a pH of 3.0 to 4.5. The air in the containers has been displaced by nitrogen gas.</Description>
</NDC>
<NDC>
<NDCCode>38779-3375-4</NDCCode>
<PackageDescription>25 g in 1 BOTTLE (38779-3375-4) </PackageDescription>
<NDC11Code>38779-3375-04</NDC11Code>
<ProductNDC>38779-3375</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260527</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-06-05</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-MAY-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68071-3375-1</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68071-3375-1) </PackageDescription>
<NDC11Code>68071-3375-01</NDC11Code>
<ProductNDC>68071-3375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203512</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are indicated in the management of. Primary hyperaldosteronism for:. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:.</IndicationAndUsage>
<Description>Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths.</Description>
</NDC>
<NDC>
<NDCCode>68071-3375-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68071-3375-3) </PackageDescription>
<NDC11Code>68071-3375-03</NDC11Code>
<ProductNDC>68071-3375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203512</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are indicated in the management of. Primary hyperaldosteronism for:. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:.</IndicationAndUsage>
<Description>Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths.</Description>
</NDC>
<NDC>
<NDCCode>68071-3375-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68071-3375-6) </PackageDescription>
<NDC11Code>68071-3375-06</NDC11Code>
<ProductNDC>68071-3375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203512</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are indicated in the management of. Primary hyperaldosteronism for:. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:.</IndicationAndUsage>
<Description>Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths.</Description>
</NDC>
<NDC>
<NDCCode>68071-3375-8</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (68071-3375-8) </PackageDescription>
<NDC11Code>68071-3375-08</NDC11Code>
<ProductNDC>68071-3375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203512</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are indicated in the management of. Primary hyperaldosteronism for:. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:.</IndicationAndUsage>
<Description>Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths.</Description>
</NDC>
<NDC>
<NDCCode>68071-3375-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68071-3375-9) </PackageDescription>
<NDC11Code>68071-3375-09</NDC11Code>
<ProductNDC>68071-3375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203512</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are indicated in the management of. Primary hyperaldosteronism for:. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:.</IndicationAndUsage>
<Description>Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths.</Description>
</NDC>
<NDC>
<NDCCode>83021-551-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (83021-551-50) </PackageDescription>
<NDC11Code>83021-0551-50</NDC11Code>
<ProductNDC>83021-551</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubismed</ProprietaryName>
<NonProprietaryName>Spf 50 Broad Spectrum Protection Fluid Emulsion</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221015</StartMarketingDate>
<EndMarketingDate>20270429</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; GLYCERIN; LINOLENIC ACID; TROMETHAMINE; OCTOCRYLENE; BUTYLATED HYDROXYTOLUENE; PROPYLENE GLYCOL; WATER; FRAGRANCE 13576; CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED); .ALPHA.-TOCOPHEROL; POLY(METHYL METHACRYLATE; 450000 MW); AVOBENZONE; TITANIUM DIOXIDE; PHENOXYETHANOL; POLYETHYLENE GLYCOL 400; LINOLEIC ACID; SILICON DIOXIDE; ANHYDROUS CITRIC ACID; ASCORBYL PALMITATE; ASCORBIC ACID; OCTISALATE; BEMOTRIZINOL; DIMETHICONE; OCTINOXATE; BUTYLENE GLYCOL; C20-22 ALCOHOLS; CHLORPHENESIN</SubstanceName>
<StrengthNumber>.025; .005; .00275; .22; 1.8; .0018; 2.5; 27.55; .3; .075; .006; 2.1; 1.8; .425; .35; .14225; .49725; .575; .00025; .00125; .00025; 1.8; 1.45; 1.25; 3.5982; 2.5; .3375; .1</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Allergens [CS], Anti-coagulant [EPC], Ascorbic Acid [CS], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221015</StartMarketingDatePackage>
<EndMarketingDatePackage>20270429</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-686-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (83021-686-50) </PackageDescription>
<NDC11Code>83021-0686-50</NDC11Code>
<ProductNDC>83021-686</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Protective Line</ProprietaryName>
<NonProprietaryName>Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221102</StartMarketingDate>
<EndMarketingDate>20280309</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; CHLORPHENESIN; OCTISALATE; BUTYLENE GLYCOL; PROPYLENE GLYCOL; POLY(METHYL METHACRYLATE; 450000 MW); WATER; SILICON DIOXIDE; BUTYLATED HYDROXYTOLUENE; DIMETHICONE; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; C20-22 ALCOHOLS; FRAGRANCE 13576; CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED); TROMETHAMINE; BEMOTRIZINOL; POLYETHYLENE GLYCOL 400; ASCORBYL PALMITATE; PHENOXYETHANOL; OCTOCRYLENE; AVOBENZONE; LINOLENIC ACID; ASCORBIC ACID; TOCOPHEROL; LINOLEIC ACID; GLYCERIN</SubstanceName>
<StrengthNumber>3.5982; .425; .1; 1.8; 2.5; 2.5; 2.1; 27.55; .575; .0018; 1.25; .025; .3375; .3; .075; .22; 1.45; .14225; .00125; .35; 1.8; 1.8; .00275; .00025; .006; .49725; .005</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221102</StartMarketingDatePackage>
<EndMarketingDatePackage>20280309</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</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>0409-0009-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0009-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-0009-02) </PackageDescription>
<NDC11Code>00409-0009-25</NDC11Code>
<ProductNDC>0409-0009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20241216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077548</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1), 2 postoperative nausea and/or vomiting. (1.2).</IndicationAndUsage>
<Description>The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9‑ tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3O∙HCl∙2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution in the 2-mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.46 mg of citric acid anhydrous, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0.</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>0409-0032-01</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>0409-0124-01</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>2026-07-17</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>0409-0181-25</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0181-25) / 26.3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0181-25</NDC11Code>
<ProductNDC>0409-0181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemcitabine</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130709</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200795</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
<Description>Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine HCl is a white to off-white solid with a molecular formula of C9H11F2N3O4 ∙HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.7 mg, 1.139 g, or 2.227 g of gemcitabine HCl. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.27 mg of gemcitabine HCl. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>0409-0182-25</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0182-25) / 52.6 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0182-25</NDC11Code>
<ProductNDC>0409-0182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemcitabine</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200795</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
<Description>Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine HCl is a white to off-white solid with a molecular formula of C9H11F2N3O4 ∙HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.7 mg, 1.139 g, or 2.227 g of gemcitabine HCl. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.27 mg of gemcitabine HCl. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>0409-0183-25</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0183-25) / 5.26 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0183-25</NDC11Code>
<ProductNDC>0409-0183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemcitabine</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130709</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200795</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
<Description>Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine HCl is a white to off-white solid with a molecular formula of C9H11F2N3O4 ∙HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.7 mg, 1.139 g, or 2.227 g of gemcitabine HCl. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.27 mg of gemcitabine HCl. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>0409-0186-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0186-01) / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0186-01</NDC11Code>
<ProductNDC>0409-0186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemcitabine</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078339</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemcitabine is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
<Description>Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer) with the following structural formula. The empirical formula for gemcitabine hydrochloride is C9H11F2N3O4 ∙ HCl. It has a molecular weight of 299.66 g/mol. Gemcitabine hydrochloride is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine hydrochloride is a sterile white to off-white lyophilized powder and available as 200 mg and 1 g single-dose vials for intravenous use only. Each 200 mg vial contains 200 mg gemcitabine (equivalent to 227.7 mg gemcitabine hydrochloride), 200 mg mannitol and 12.5 mg sodium acetate. Each 1 g vial contains 1 g gemcitabine (equivalent to 1.139 g gemcitabine hydrochloride), 1 g mannitol, and 62.5 mg sodium acetate. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>0409-0201-25</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0409-0201-25) > 2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00409-0201-25</NDC11Code>
<ProductNDC>0409-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130909</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>Deprecated</Status>
<LastUpdate>2017-03-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-0217-01</NDCCode>
<PackageDescription>25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON (0409-0217-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-0217-11) </PackageDescription>
<NDC11Code>00409-0217-01</NDC11Code>
<ProductNDC>0409-0217</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maxipime</ProprietaryName>
<NonProprietaryName>Cefepime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130218</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050679</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CEFEPIME HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130218</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-0218-01</NDCCode>
<PackageDescription>25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON (0409-0218-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-0218-11) </PackageDescription>
<NDC11Code>00409-0218-01</NDC11Code>
<ProductNDC>0409-0218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maxipime</ProprietaryName>
<NonProprietaryName>Cefepime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050679</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CEFEPIME HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-0302-25</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0409-0302-25) > 4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00409-0302-25</NDC11Code>
<ProductNDC>0409-0302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topotecan</ProprietaryName>
<NonProprietaryName>Topotecan</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130924</StartMarketingDate>
<EndMarketingDate>20180131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200582</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>TOPOTECAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130924</StartMarketingDatePackage>
<EndMarketingDatePackage>20180131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-0525-25</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (0409-0525-25) / 50 mL in 1 VIAL, MULTI-DOSE (0409-0525-01) </PackageDescription>
<NDC11Code>00409-0525-25</NDC11Code>
<ProductNDC>0409-0525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Marcaine</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERINEURAL</RouteName>
<StartMarketingDate>20241209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016964</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults 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 MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula. MARCAINE (bupivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. MARCAINE with epinephrine 1:200,000 (as bitartrate) is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.0091 mg epinephrine bitartrate (equivalent to 0.005 mg of epinephrine), with sodium chloride for isotonicity, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008.</Description>
</NDC>
<NDC>
<NDCCode>0409-0528-25</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0409-0528-25) / 1 BAG in 1 POUCH / 100 mL in 1 BAG (0409-0528-23) </PackageDescription>
<NDC11Code>00409-0528-25</NDC11Code>
<ProductNDC>0409-0528</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078579</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin Injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. The empirical formula is C18H20FN3O4 ∙ ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2.</Description>
</NDC>
<NDC>
<NDCCode>0409-0802-01</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (0409-0802-01) > 16.7 mL in 1 VIAL</PackageDescription>
<NDC11Code>00409-0802-01</NDC11Code>
<ProductNDC>0409-0802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime</ProprietaryName>
<NonProprietaryName>Cefuroxime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065503</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CEFUROXIME SODIUM</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-0805-01</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (0409-0805-01) > 3 mL in 1 VIAL (0409-0805-11) </PackageDescription>
<NDC11Code>00409-0805-01</NDC11Code>
<ProductNDC>0409-0805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefazolin</ProprietaryName>
<NonProprietaryName>Cefazolin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065226</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/3mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-0805-02</NDCCode>
<PackageDescription>25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON (0409-0805-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-0805-12)</PackageDescription>
<NDC11Code>00409-0805-02</NDC11Code>
<ProductNDC>0409-0805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefazolin</ProprietaryName>
<NonProprietaryName>Cefazolin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201654</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-0805-50</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (0409-0805-50) > 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>00409-0805-50</NDC11Code>
<ProductNDC>0409-0805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefazolin</ProprietaryName>
<NonProprietaryName>Cefazolin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065226</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/3mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-19</LastUpdate>
</NDC>
</NDCList>