{
"NDC": [
{
"NDCCode": "0409-3382-21",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3382-21) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3382-11) ",
"NDC11Code": "00409-3382-21",
"ProductNDC": "0409-3382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sufentanil Citrate",
"NonProprietaryName": "Sufentanil Citrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRAVENOUS",
"StartMarketingDate": "20050726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074534",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SUFENTANIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050726",
"SamplePackage": "N",
"IndicationAndUsage": "Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients: 1 as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated., 2 as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.",
"Description": "Sufentanil Citrate Injection, USP is a sterile, nonpyrogenic solution of sufentanil citrate in water for injection. Sufentanil Citrate is a potent opioid analgesic which is administered either epidurally or by intravenous injection. Each mL contains sufentanil citrate equivalent to 50 mcg of sufentanil. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 4.2 (3.5 to 6.0). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-use injection. When smaller doses are required, the unused portion should be discarded in an appropriate manner. Sufentanil Citrate, USP, occurs as a white crystalline powder and is chemically designated as N-[-4-(methyoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The molecular formula of sufentanil citrate is C22H30N2O2S∙C6H8O7 and the molecular weight is 578.69. Sufentanil Citrate has the following structural formula."
},
{
"NDCCode": "0409-3382-22",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3382-22) > 2 mL in 1 VIAL, SINGLE-DOSE (0409-3382-12) ",
"NDC11Code": "00409-3382-22",
"ProductNDC": "0409-3382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sufentanil Citrate",
"NonProprietaryName": "Sufentanil Citrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRAVENOUS",
"StartMarketingDate": "20050726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074534",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SUFENTANIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20050808",
"EndMarketingDatePackage": "20220201",
"SamplePackage": "N"
},
{
"NDCCode": "0409-3382-25",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3382-25) > 5 mL in 1 VIAL, SINGLE-DOSE (0409-3382-15) ",
"NDC11Code": "00409-3382-25",
"ProductNDC": "0409-3382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sufentanil Citrate",
"NonProprietaryName": "Sufentanil Citrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRAVENOUS",
"StartMarketingDate": "20050726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074534",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SUFENTANIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20051025",
"EndMarketingDatePackage": "20220201",
"SamplePackage": "N"
},
{
"NDCCode": "0409-3382-49",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0409-3382-49) > 1 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00409-3382-49",
"ProductNDC": "0409-3382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sufentanil Citrate",
"NonProprietaryName": "Sufentanil Citrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRAVENOUS",
"StartMarketingDate": "20050726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074534",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SUFENTANIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-05-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-3382-50",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0409-3382-50) > 2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00409-3382-50",
"ProductNDC": "0409-3382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sufentanil Citrate",
"NonProprietaryName": "Sufentanil Citrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRAVENOUS",
"StartMarketingDate": "20050726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074534",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SUFENTANIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-05-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-3382-51",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0409-3382-51) > 5 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00409-3382-51",
"ProductNDC": "0409-3382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sufentanil Citrate",
"NonProprietaryName": "Sufentanil Citrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRAVENOUS",
"StartMarketingDate": "20050726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074534",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SUFENTANIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-05-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-3382-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-3382-0) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55154-3382-00",
"ProductNDC": "55154-3382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078865",
"LabelerName": "Cardinal Health",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-03-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0409-0144-11",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (0409-0144-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0144-21) ",
"NDC11Code": "00409-0144-11",
"ProductNDC": "0409-0144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065500",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090626",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for Injection, USP is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Azithromycin for Injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12 ∙ H2O and a molecular weight of 767. Azithromycin for Injection, USP consists of azithromycin monohydrate and the following inactive ingredients: anhydrous citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. Azithromycin for Injection, USP is supplied as white to off-white lyophilized powder in a single-dose ADD-Vantage® vial for intravenous administration only after reconstitution, according to directions in the Dosage and Administration section. Each ADD-Vantage® vial contains azithromycin monohydrate equivalent to 500 mg azithromycin, 392 mg anhydrous citric acid and sodium hydroxide for pH adjustment."
},
{
"NDCCode": "0409-1215-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1215-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1215-21) ",
"NDC11Code": "00409-1215-01",
"ProductNDC": "0409-1215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070256",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050712",
"SamplePackage": "N",
"IndicationAndUsage": "Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock).",
"Description": "Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sodium chloride to adjust tonicity in water for injection. May contain hydrochloric acid for pH adjustment; pH 4.0 (3.0 to 6.5). The single-dose solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. The multiple-dose solution contains, in addition, 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben added as preservatives. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula."
},
{
"NDCCode": "0409-1390-51",
"PackageDescription": "10 VIAL in 1 CARTON (0409-1390-51) / 10 mL in 1 VIAL (0409-1390-21) ",
"NDC11Code": "00409-1390-51",
"ProductNDC": "0409-1390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meropenem",
"NonProprietaryName": "Meropenem",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091404",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEROPENEM",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191009",
"SamplePackage": "N",
"IndicationAndUsage": "Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 1 4.Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1), 2 5.Complicated intra-abdominal infections (adult and pediatric patients). (1.2), 3 6.Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3).",
"Description": "Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [see Dosage and Administration (2.4)]."
},
{
"NDCCode": "0409-1391-22",
"PackageDescription": "10 VIAL in 1 CARTON (0409-1391-22) / 20 mL in 1 VIAL (0409-1391-21) ",
"NDC11Code": "00409-1391-22",
"ProductNDC": "0409-1391",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meropenem",
"NonProprietaryName": "Meropenem",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091404",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEROPENEM",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191009",
"SamplePackage": "N",
"IndicationAndUsage": "Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 1 4.Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1), 2 5.Complicated intra-abdominal infections (adult and pediatric patients). (1.2), 3 6.Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3).",
"Description": "Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [see Dosage and Administration (2.4)]."
},
{
"NDCCode": "0409-1623-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1623-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1623-21) ",
"NDC11Code": "00409-1623-01",
"ProductNDC": "0409-1623",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butorphanol Tartrate",
"NonProprietaryName": "Butorphanol Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074626",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUTORPHANOL TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050923",
"SamplePackage": "N",
"IndicationAndUsage": "Butorphanol Tartrate Injection is indicated : 1 -as a preoperative or pre-anesthetic medication , 2 -as a supplement to balanced anesthesia , 3 -for the relief of pain during labor, and , 4 -for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. .",
"Description": "Butorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl) morphinan-3, 14-diol D-(-)- tartrate (1:1) (salt). The molecular formula is C21H29NO2 ∙ C4H6O6, which corresponds to a molecular weight of 477.56 and the following structural formula. Butorphanol tartrate is a white crystalline substance. The dose is expressed as the tartrate salt. One milligram of the salt is equivalent to 0.68 mg of the free base. The n-octanol/aqueous buffer partition coefficient of butorphanol is 180:1 at pH 7.5. Butorphanol Tartrate Injection is a sterile, nonpyrogenic parenteral aqueous solution of butorphanol tartrate for intravenous or intramuscular administration. Each milliliter (mL) contains butorphanol tartrate 1 or 2 mg; sodium citrate, dihydrate, 6.4 mg; citric acid hydrous 3.3 mg; sodium chloride 6.4 mg. The pH is 4.5 (3.0 to 5.5)."
},
{
"NDCCode": "0409-1626-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-21) ",
"NDC11Code": "00409-1626-01",
"ProductNDC": "0409-1626",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butorphanol Tartrate",
"NonProprietaryName": "Butorphanol Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20051220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074626",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUTORPHANOL TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060317",
"SamplePackage": "N",
"IndicationAndUsage": "Butorphanol Tartrate Injection is indicated : 1 -as a preoperative or pre-anesthetic medication , 2 -as a supplement to balanced anesthesia , 3 -for the relief of pain during labor, and , 4 -for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. .",
"Description": "Butorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl) morphinan-3, 14-diol D-(-)- tartrate (1:1) (salt). The molecular formula is C21H29NO2 ∙ C4H6O6, which corresponds to a molecular weight of 477.56 and the following structural formula. Butorphanol tartrate is a white crystalline substance. The dose is expressed as the tartrate salt. One milligram of the salt is equivalent to 0.68 mg of the free base. The n-octanol/aqueous buffer partition coefficient of butorphanol is 180:1 at pH 7.5. Butorphanol Tartrate Injection is a sterile, nonpyrogenic parenteral aqueous solution of butorphanol tartrate for intravenous or intramuscular administration. Each milliliter (mL) contains butorphanol tartrate 1 or 2 mg; sodium citrate, dihydrate, 6.4 mg; citric acid hydrous 3.3 mg; sodium chloride 6.4 mg. The pH is 4.5 (3.0 to 5.5)."
},
{
"NDCCode": "0409-1632-01",
"PackageDescription": "10 VIAL in 1 CARTON (0409-1632-01) / 10 mL in 1 VIAL (0409-1632-21) ",
"NDC11Code": "00409-1632-01",
"ProductNDC": "0409-1632",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vecuronium Bromide",
"NonProprietaryName": "Vecuronium Bromide",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20060228",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075164",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "VECURONIUM BROMIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060228",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Vecuronium bromide for injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as 1-(3α,17β-Dihydroxy-2β-piperidino-5α-androstan-16β,5α-yl)-1-methylpiperidinium bromide, diacetate. Vecuronium bromide for injection is prepared as a solution and lyophilized in its final container. The structural formula is. Its chemical formula is C34H57BrN2O4 with molecular weight 637.73. Vecuronium bromide is supplied as a sterile nonpyrogenic freeze-dried buffered cake of very fine microscopic crystalline particles for intravenous injection only. Each 10 mL vial contains 10 mg vecuronium bromide, 20.75 mg citric acid anhydrous, 16.25 mg sodium phosphate dibasic anhydrous, 97 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH of 4 (3.5 to 4.5). Each 20 mL vial contains 20 mg of vecuronium bromide, 41.5 mg citric acid anhydrous, 32.5 mg sodium phosphate dibasic anhydrous, 194 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH of 4 (3.5 to 4.5). Bacteriostatic water for injection, USP when used contains BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS."
},
{
"NDCCode": "0409-1639-10",
"PackageDescription": "10 CARTON in 1 PACKAGE (0409-1639-10) / 1 SYRINGE, PLASTIC in 1 CARTON (0409-1639-21) / 10 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00409-1639-10",
"ProductNDC": "0409-1639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20060131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075241",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20060131",
"SamplePackage": "N"
},
{
"NDCCode": "0409-2287-21",
"PackageDescription": "10 CARTRIDGE in 1 BOX (0409-2287-21) > 1 mL in 1 CARTRIDGE",
"NDC11Code": "00409-2287-21",
"ProductNDC": "0409-2287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19990127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074993",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0409-2288-21",
"PackageDescription": "10 CARTRIDGE in 1 BOX (0409-2288-21) > 1 mL in 1 CARTRIDGE",
"NDC11Code": "00409-2288-21",
"ProductNDC": "0409-2288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19990127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074993",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0409-2305-21",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-2305-21) > 2 mL in 1 VIAL, SINGLE-DOSE (0409-2305-20) ",
"NDC11Code": "00409-2305-21",
"ProductNDC": "0409-2305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midazolam Hydrochloride",
"NonProprietaryName": "Midazolam Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075857",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100728",
"EndMarketingDatePackage": "20201001",
"SamplePackage": "N"
},
{
"NDCCode": "0409-2307-21",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0409-2307-21) > 10 SYRINGE in 1 BLISTER PACK > 1 mL in 1 SYRINGE",
"NDC11Code": "00409-2307-21",
"ProductNDC": "0409-2307",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midazolam Hydrochloride",
"NonProprietaryName": "Midazolam Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20020613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075856",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0409-2308-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2308-21) ",
"NDC11Code": "00409-2308-01",
"ProductNDC": "0409-2308",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midazolam",
"NonProprietaryName": "Midazolam Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075857",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050614",
"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": "0409-2689-01",
"PackageDescription": "10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21) ",
"NDC11Code": "00409-2689-01",
"ProductNDC": "0409-2689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin Sodium And Sulbactam Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20060725",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065310",
"LabelerName": "Hospira, Inc",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "1; .5",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170825",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*. NOTE: For information on use in pediatric patients (see PRECAUTIONS - Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*). * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While ampicillin and sulbactam for injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection and other antibacterial drugs, ampicillin and sulbactam for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Ampicillin and sulbactam for injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and sulbactam for injection, USP parenteral combination, is available as a white to yellowish dry powder for reconstitution. Ampicillin and sulbactam for injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each 1.5 g ADD-Vantage® vial contains 1.5 g ampicillin and sulbactam for injection, USP (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). The sodium content is 115 mg (5 mEq). Each 3 g ADD-Vantage® vial contains 3 g ampicillin and sulbactam for injection, USP (equivalent to 2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt). The sodium content is 230 mg (10 mEq)."
},
{
"NDCCode": "0409-3182-02",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-3182-02) / 30 mL in 1 VIAL, MULTI-DOSE (0409-3182-21) ",
"NDC11Code": "00409-3182-02",
"ProductNDC": "0409-3182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20050623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089646",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "20; 10",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20051229",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
},
{
"NDCCode": "0409-3414-11",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3414-11) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3414-21) ",
"NDC11Code": "00409-3414-11",
"ProductNDC": "0409-3414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20060202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073118",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240826",
"SamplePackage": "N",
"IndicationAndUsage": "Diabetic Gastroparesis (Diabetic Gastric Stasis). Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy. Metoclopramide Injection, USP is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy. The Prevention of Postoperative Nausea and Vomiting. Metoclopramide Injection, USP is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable. Small Bowel Intubation. Metoclopramide Injection, USP may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers. Radiological Examination. Metoclopramide Injection, USP may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.",
"Description": "Metoclopramide hydrochloride is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform, practically insoluble in ether. Chemically it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide monohydrochloride monohydrate. It has the following structural formula:. Molecular formula: C14H22ClN3O2 HCl H2O. Metoclopramide Injection, USP is a sterile, nonpyrogenic solution of metoclopramide hydrochloride in water for injection. Each milliliter contains metoclopramide base 5 mg (as the hydrochloride monohydrate); 8.5 mg sodium chloride. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment; pH 4.4 (2.5 to 6.5). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Metoclopramide Injection is intended for intravenous or intramuscular administration."
},
{
"NDCCode": "0409-3507-01",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0409-3507-01) > 100 mL in 1 VIAL, SINGLE-DOSE (0409-3507-21) ",
"NDC11Code": "00409-3507-01",
"ProductNDC": "0409-3507",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipenem And Cilastatin",
"NonProprietaryName": "Imipenem And Cilastatin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20111116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090825",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "IMIPENEM; CILASTATIN SODIUM",
"StrengthNumber": "500; 500",
"StrengthUnit": "mg/100mL; mg/100mL",
"Pharm_Classes": "Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20111116",
"SamplePackage": "N"
},
{
"NDCCode": "0409-3508-01",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0409-3508-01) > 100 mL in 1 VIAL, SINGLE-DOSE (0409-3508-21) ",
"NDC11Code": "00409-3508-01",
"ProductNDC": "0409-3508",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipenem And Cilastatin",
"NonProprietaryName": "Imipenem And Cilastatin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20111116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090825",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "IMIPENEM; CILASTATIN SODIUM",
"StrengthNumber": "250; 250",
"StrengthUnit": "mg/100mL; mg/100mL",
"Pharm_Classes": "Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20111116",
"SamplePackage": "N"
},
{
"NDCCode": "0409-3510-22",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3510-22) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-3510-21) ",
"NDC11Code": "00409-3510-22",
"ProductNDC": "0409-3510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ertapenem",
"NonProprietaryName": "Ertapenem",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20201019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208790",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ERTAPENEM SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201019",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for Injection and other antibacterial drugs, Ertapenem for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment. Ertapenem for Injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms [see Dosage and Administration (2)].",
"Description": "Ertapenem for Injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, Ertapenem for Injection is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.5. The empirical formula is C22H24N3O7SNa, and its structural formula is. Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran. Ertapenem for Injection is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent [see Dosage and Administration (2.7)] and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each vial contains 1.046 grams ertapenem sodium, equivalent to 1 gram ertapenem. The sodium content is approximately 137 mg (approximately 6 mEq). Each vial of Ertapenem for Injection contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5."
},
{
"NDCCode": "0409-4777-02",
"PackageDescription": "24 POUCH in 1 CASE (0409-4777-02) > 1 BAG in 1 POUCH > 200 mL in 1 BAG (0409-4777-21) ",
"NDC11Code": "00409-4777-02",
"ProductNDC": "0409-4777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077753",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CIPROFLOXACIN",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20080319",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin Injection (in 5% Dextrose Injection) is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Nosocomial Pneumonia (1.4), 5 Empirical Therapy for Febrile Neutropenic Patients (1.5), 6 Inhalational Anthrax post-exposure in adult and pediatric patients (1.6), 7 Plague in adult and pediatric patients (1.7), 8 Chronic Bacterial Prostatitis (1.8), 9 Lower Respiratory Tract Infections (1.9) Acute exacerbation of chronic bronchitis, 10 Urinary Tract Infections (1.10) Urinary Tract Infections (UTI)Complicated UTI and Pyelonephritis in Pediatric Patients, 11 Acute Sinusitis (1.11).",
"Description": "Ciprofloxacin Injection is a synthetic antimicrobial agent for intravenous (IV) administration. Ciprofloxacin, a fluoroquinolone, is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its chemical structure is. Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 331.4. It is soluble in dilute (0.1N) hydrochloric acid and is practically insoluble in water and ethanol. Ciprofloxacin is available as a 2 mg/mL ready-for-use infusion solution in 5% Dextrose Injection. The formula contains lactic acid as a solubilizing agent and hydrochloric acid for pH adjustment. The pH range for the solution is 3.5 to 4.6. The flexible plastic container is latex-free and is fabricated from a specially formulated polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, for example, di(2-ethylhexyl) phthalate (DEHP), up to 5 parts per million. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0409-6533-21",
"PackageDescription": "10 VIAL in 1 CARTON (0409-6533-21) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0409-6533-11) ",
"NDC11Code": "00409-6533-21",
"ProductNDC": "0409-6533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062912",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210322",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection and other antibacterial drugs, vancomycin hydrochloride for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin hydrochloride for injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg, 750 mg, 1 g or 1.5 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol, 750 mg of the base are equivalent to 0.51 mmol, 1 g of the base are equivalent to 0.67 mmol and 1.5 g of the base are equivalent to 1.01 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S- [3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 ∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula."
},
{
"NDCCode": "0409-6729-03",
"PackageDescription": "24 POUCH in 1 CASE (0409-6729-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0409-6729-21) ",
"NDC11Code": "00409-6729-03",
"ProductNDC": "0409-6729",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Magnesium Sulfate In Water",
"NonProprietaryName": "Magnesium Sulfate In Water",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050822",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020309",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20050822",
"EndMarketingDatePackage": "20240201",
"SamplePackage": "N",
"IndicationAndUsage": "Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.",
"Description": "Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4 7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "0409-7332-20",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0409-7332-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (0409-7332-21) ",
"NDC11Code": "00409-7332-20",
"ProductNDC": "0409-7332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ceftriaxone Sodium",
"NonProprietaryName": "Ceftriaxone Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065169",
"LabelerName": "Hospira, Inc",
"SubstanceName": "CEFTRIAXONE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180319",
"SamplePackage": "N",
"IndicationAndUsage": "Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms.",
"Description": "Ceftriaxone for injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R, 7R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S33.5H2O. It has a calculated molecular weight of 661.60 and the following structural formula. Ceftriaxone sodium is a white to yellowish crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams of ceftriaxone activity. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity."
}
]
}
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<NDCList>
<NDC>
<NDCCode>0409-3382-21</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3382-21) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3382-11) </PackageDescription>
<NDC11Code>00409-3382-21</NDC11Code>
<ProductNDC>0409-3382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sufentanil Citrate</ProprietaryName>
<NonProprietaryName>Sufentanil Citrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20050726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074534</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SUFENTANIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients: 1 as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated., 2 as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.</IndicationAndUsage>
<Description>Sufentanil Citrate Injection, USP is a sterile, nonpyrogenic solution of sufentanil citrate in water for injection. Sufentanil Citrate is a potent opioid analgesic which is administered either epidurally or by intravenous injection. Each mL contains sufentanil citrate equivalent to 50 mcg of sufentanil. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 4.2 (3.5 to 6.0). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-use injection. When smaller doses are required, the unused portion should be discarded in an appropriate manner. Sufentanil Citrate, USP, occurs as a white crystalline powder and is chemically designated as N-[-4-(methyoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The molecular formula of sufentanil citrate is C22H30N2O2S∙C6H8O7 and the molecular weight is 578.69. Sufentanil Citrate has the following structural formula.</Description>
</NDC>
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<NDCCode>0409-3382-22</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3382-22) > 2 mL in 1 VIAL, SINGLE-DOSE (0409-3382-12) </PackageDescription>
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<ProductNDC>0409-3382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sufentanil Citrate</ProprietaryName>
<NonProprietaryName>Sufentanil Citrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20050726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074534</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SUFENTANIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050808</StartMarketingDatePackage>
<EndMarketingDatePackage>20220201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-3382-25</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3382-25) > 5 mL in 1 VIAL, SINGLE-DOSE (0409-3382-15) </PackageDescription>
<NDC11Code>00409-3382-25</NDC11Code>
<ProductNDC>0409-3382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sufentanil Citrate</ProprietaryName>
<NonProprietaryName>Sufentanil Citrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20050726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074534</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SUFENTANIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051025</StartMarketingDatePackage>
<EndMarketingDatePackage>20220201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-3382-49</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0409-3382-49) > 1 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00409-3382-49</NDC11Code>
<ProductNDC>0409-3382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sufentanil Citrate</ProprietaryName>
<NonProprietaryName>Sufentanil Citrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20050726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074534</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SUFENTANIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-05-17</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<NDCCode>0409-3382-50</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0409-3382-50) > 2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00409-3382-50</NDC11Code>
<ProductNDC>0409-3382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sufentanil Citrate</ProprietaryName>
<NonProprietaryName>Sufentanil Citrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20050726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074534</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SUFENTANIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-05-17</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<NDCCode>0409-3382-51</NDCCode>
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<NDC11Code>00409-3382-51</NDC11Code>
<ProductNDC>0409-3382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sufentanil Citrate</ProprietaryName>
<NonProprietaryName>Sufentanil Citrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20050726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074534</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SUFENTANIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-05-17</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-3382-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-3382-0) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-3382-00</NDC11Code>
<ProductNDC>55154-3382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078865</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-0144-11</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (0409-0144-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0144-21) </PackageDescription>
<NDC11Code>00409-0144-11</NDC11Code>
<ProductNDC>0409-0144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065500</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for Injection, USP is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Azithromycin for Injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12 ∙ H2O and a molecular weight of 767. Azithromycin for Injection, USP consists of azithromycin monohydrate and the following inactive ingredients: anhydrous citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. Azithromycin for Injection, USP is supplied as white to off-white lyophilized powder in a single-dose ADD-Vantage® vial for intravenous administration only after reconstitution, according to directions in the Dosage and Administration section. Each ADD-Vantage® vial contains azithromycin monohydrate equivalent to 500 mg azithromycin, 392 mg anhydrous citric acid and sodium hydroxide for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>0409-1215-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1215-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1215-21) </PackageDescription>
<NDC11Code>00409-1215-01</NDC11Code>
<ProductNDC>0409-1215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070256</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock).</IndicationAndUsage>
<Description>Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sodium chloride to adjust tonicity in water for injection. May contain hydrochloric acid for pH adjustment; pH 4.0 (3.0 to 6.5). The single-dose solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. The multiple-dose solution contains, in addition, 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben added as preservatives. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0409-1390-51</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0409-1390-51) / 10 mL in 1 VIAL (0409-1390-21) </PackageDescription>
<NDC11Code>00409-1390-51</NDC11Code>
<ProductNDC>0409-1390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meropenem</ProprietaryName>
<NonProprietaryName>Meropenem</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091404</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEROPENEM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 1 4.Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1), 2 5.Complicated intra-abdominal infections (adult and pediatric patients). (1.2), 3 6.Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3).</IndicationAndUsage>
<Description>Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [see Dosage and Administration (2.4)].</Description>
</NDC>
<NDC>
<NDCCode>0409-1391-22</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0409-1391-22) / 20 mL in 1 VIAL (0409-1391-21) </PackageDescription>
<NDC11Code>00409-1391-22</NDC11Code>
<ProductNDC>0409-1391</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meropenem</ProprietaryName>
<NonProprietaryName>Meropenem</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091404</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEROPENEM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 1 4.Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1), 2 5.Complicated intra-abdominal infections (adult and pediatric patients). (1.2), 3 6.Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3).</IndicationAndUsage>
<Description>Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [see Dosage and Administration (2.4)].</Description>
</NDC>
<NDC>
<NDCCode>0409-1623-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1623-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1623-21) </PackageDescription>
<NDC11Code>00409-1623-01</NDC11Code>
<ProductNDC>0409-1623</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butorphanol Tartrate</ProprietaryName>
<NonProprietaryName>Butorphanol Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20050923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074626</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUTORPHANOL TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butorphanol Tartrate Injection is indicated : 1 -as a preoperative or pre-anesthetic medication , 2 -as a supplement to balanced anesthesia , 3 -for the relief of pain during labor, and , 4 -for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. .</IndicationAndUsage>
<Description>Butorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl) morphinan-3, 14-diol D-(-)- tartrate (1:1) (salt). The molecular formula is C21H29NO2 ∙ C4H6O6, which corresponds to a molecular weight of 477.56 and the following structural formula. Butorphanol tartrate is a white crystalline substance. The dose is expressed as the tartrate salt. One milligram of the salt is equivalent to 0.68 mg of the free base. The n-octanol/aqueous buffer partition coefficient of butorphanol is 180:1 at pH 7.5. Butorphanol Tartrate Injection is a sterile, nonpyrogenic parenteral aqueous solution of butorphanol tartrate for intravenous or intramuscular administration. Each milliliter (mL) contains butorphanol tartrate 1 or 2 mg; sodium citrate, dihydrate, 6.4 mg; citric acid hydrous 3.3 mg; sodium chloride 6.4 mg. The pH is 4.5 (3.0 to 5.5).</Description>
</NDC>
<NDC>
<NDCCode>0409-1626-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-21) </PackageDescription>
<NDC11Code>00409-1626-01</NDC11Code>
<ProductNDC>0409-1626</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butorphanol Tartrate</ProprietaryName>
<NonProprietaryName>Butorphanol Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20051220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074626</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUTORPHANOL TARTRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butorphanol Tartrate Injection is indicated : 1 -as a preoperative or pre-anesthetic medication , 2 -as a supplement to balanced anesthesia , 3 -for the relief of pain during labor, and , 4 -for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. .</IndicationAndUsage>
<Description>Butorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl) morphinan-3, 14-diol D-(-)- tartrate (1:1) (salt). The molecular formula is C21H29NO2 ∙ C4H6O6, which corresponds to a molecular weight of 477.56 and the following structural formula. Butorphanol tartrate is a white crystalline substance. The dose is expressed as the tartrate salt. One milligram of the salt is equivalent to 0.68 mg of the free base. The n-octanol/aqueous buffer partition coefficient of butorphanol is 180:1 at pH 7.5. Butorphanol Tartrate Injection is a sterile, nonpyrogenic parenteral aqueous solution of butorphanol tartrate for intravenous or intramuscular administration. Each milliliter (mL) contains butorphanol tartrate 1 or 2 mg; sodium citrate, dihydrate, 6.4 mg; citric acid hydrous 3.3 mg; sodium chloride 6.4 mg. The pH is 4.5 (3.0 to 5.5).</Description>
</NDC>
<NDC>
<NDCCode>0409-1632-01</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0409-1632-01) / 10 mL in 1 VIAL (0409-1632-21) </PackageDescription>
<NDC11Code>00409-1632-01</NDC11Code>
<ProductNDC>0409-1632</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vecuronium Bromide</ProprietaryName>
<NonProprietaryName>Vecuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20060228</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075164</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>VECURONIUM BROMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060228</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Vecuronium bromide for injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as 1-(3α,17β-Dihydroxy-2β-piperidino-5α-androstan-16β,5α-yl)-1-methylpiperidinium bromide, diacetate. Vecuronium bromide for injection is prepared as a solution and lyophilized in its final container. The structural formula is. Its chemical formula is C34H57BrN2O4 with molecular weight 637.73. Vecuronium bromide is supplied as a sterile nonpyrogenic freeze-dried buffered cake of very fine microscopic crystalline particles for intravenous injection only. Each 10 mL vial contains 10 mg vecuronium bromide, 20.75 mg citric acid anhydrous, 16.25 mg sodium phosphate dibasic anhydrous, 97 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH of 4 (3.5 to 4.5). Each 20 mL vial contains 20 mg of vecuronium bromide, 41.5 mg citric acid anhydrous, 32.5 mg sodium phosphate dibasic anhydrous, 194 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH of 4 (3.5 to 4.5). Bacteriostatic water for injection, USP when used contains BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS.</Description>
</NDC>
<NDC>
<NDCCode>0409-1639-10</NDCCode>
<PackageDescription>10 CARTON in 1 PACKAGE (0409-1639-10) / 1 SYRINGE, PLASTIC in 1 CARTON (0409-1639-21) / 10 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00409-1639-10</NDC11Code>
<ProductNDC>0409-1639</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20060131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075241</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-2287-21</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 BOX (0409-2287-21) > 1 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00409-2287-21</NDC11Code>
<ProductNDC>0409-2287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19990127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074993</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-2288-21</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 BOX (0409-2288-21) > 1 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00409-2288-21</NDC11Code>
<ProductNDC>0409-2288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19990127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074993</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-2305-21</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-2305-21) > 2 mL in 1 VIAL, SINGLE-DOSE (0409-2305-20) </PackageDescription>
<NDC11Code>00409-2305-21</NDC11Code>
<ProductNDC>0409-2305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midazolam Hydrochloride</ProprietaryName>
<NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20050803</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>Deprecated</Status>
<LastUpdate>2020-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100728</StartMarketingDatePackage>
<EndMarketingDatePackage>20201001</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-2307-21</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0409-2307-21) > 10 SYRINGE in 1 BLISTER PACK > 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00409-2307-21</NDC11Code>
<ProductNDC>0409-2307</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midazolam Hydrochloride</ProprietaryName>
<NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20020613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075856</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-2308-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2308-21) </PackageDescription>
<NDC11Code>00409-2308-01</NDC11Code>
<ProductNDC>0409-2308</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midazolam</ProprietaryName>
<NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20050614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075857</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</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>20050614</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>0409-2689-01</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21) </PackageDescription>
<NDC11Code>00409-2689-01</NDC11Code>
<ProductNDC>0409-2689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20060725</StartMarketingDate>
<EndMarketingDate>20261031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065310</ApplicationNumber>
<LabelerName>Hospira, Inc</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>1; .5</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170825</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*. NOTE: For information on use in pediatric patients (see PRECAUTIONS - Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*). * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While ampicillin and sulbactam for injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection and other antibacterial drugs, ampicillin and sulbactam for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Ampicillin and sulbactam for injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and sulbactam for injection, USP parenteral combination, is available as a white to yellowish dry powder for reconstitution. Ampicillin and sulbactam for injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each 1.5 g ADD-Vantage® vial contains 1.5 g ampicillin and sulbactam for injection, USP (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). The sodium content is 115 mg (5 mEq). Each 3 g ADD-Vantage® vial contains 3 g ampicillin and sulbactam for injection, USP (equivalent to 2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt). The sodium content is 230 mg (10 mEq).</Description>
</NDC>
<NDC>
<NDCCode>0409-3182-02</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (0409-3182-02) / 30 mL in 1 VIAL, MULTI-DOSE (0409-3182-21) </PackageDescription>
<NDC11Code>00409-3182-02</NDC11Code>
<ProductNDC>0409-3182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20050623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089646</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
<StrengthNumber>20; 10</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0409-3414-11</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3414-11) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3414-21) </PackageDescription>
<NDC11Code>00409-3414-11</NDC11Code>
<ProductNDC>0409-3414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20060202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073118</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diabetic Gastroparesis (Diabetic Gastric Stasis). Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy. Metoclopramide Injection, USP is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy. The Prevention of Postoperative Nausea and Vomiting. Metoclopramide Injection, USP is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable. Small Bowel Intubation. Metoclopramide Injection, USP may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers. Radiological Examination. Metoclopramide Injection, USP may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.</IndicationAndUsage>
<Description>Metoclopramide hydrochloride is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform, practically insoluble in ether. Chemically it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide monohydrochloride monohydrate. It has the following structural formula:. Molecular formula: C14H22ClN3O2 HCl H2O. Metoclopramide Injection, USP is a sterile, nonpyrogenic solution of metoclopramide hydrochloride in water for injection. Each milliliter contains metoclopramide base 5 mg (as the hydrochloride monohydrate); 8.5 mg sodium chloride. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment; pH 4.4 (2.5 to 6.5). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Metoclopramide Injection is intended for intravenous or intramuscular administration.</Description>
</NDC>
<NDC>
<NDCCode>0409-3507-01</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0409-3507-01) > 100 mL in 1 VIAL, SINGLE-DOSE (0409-3507-21) </PackageDescription>
<NDC11Code>00409-3507-01</NDC11Code>
<ProductNDC>0409-3507</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipenem And Cilastatin</ProprietaryName>
<NonProprietaryName>Imipenem And Cilastatin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20111116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090825</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>IMIPENEM; CILASTATIN SODIUM</SubstanceName>
<StrengthNumber>500; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-3508-01</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0409-3508-01) > 100 mL in 1 VIAL, SINGLE-DOSE (0409-3508-21) </PackageDescription>
<NDC11Code>00409-3508-01</NDC11Code>
<ProductNDC>0409-3508</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipenem And Cilastatin</ProprietaryName>
<NonProprietaryName>Imipenem And Cilastatin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20111116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090825</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>IMIPENEM; CILASTATIN SODIUM</SubstanceName>
<StrengthNumber>250; 250</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-3510-22</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3510-22) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-3510-21) </PackageDescription>
<NDC11Code>00409-3510-22</NDC11Code>
<ProductNDC>0409-3510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ertapenem</ProprietaryName>
<NonProprietaryName>Ertapenem</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20201019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208790</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ERTAPENEM SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for Injection and other antibacterial drugs, Ertapenem for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment. Ertapenem for Injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Ertapenem for Injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, Ertapenem for Injection is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.5. The empirical formula is C22H24N3O7SNa, and its structural formula is. Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran. Ertapenem for Injection is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent [see Dosage and Administration (2.7)] and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each vial contains 1.046 grams ertapenem sodium, equivalent to 1 gram ertapenem. The sodium content is approximately 137 mg (approximately 6 mEq). Each vial of Ertapenem for Injection contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0409-4777-02</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0409-4777-02) > 1 BAG in 1 POUCH > 200 mL in 1 BAG (0409-4777-21) </PackageDescription>
<NDC11Code>00409-4777-02</NDC11Code>
<ProductNDC>0409-4777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077753</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin Injection (in 5% Dextrose Injection) is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Nosocomial Pneumonia (1.4), 5 Empirical Therapy for Febrile Neutropenic Patients (1.5), 6 Inhalational Anthrax post-exposure in adult and pediatric patients (1.6), 7 Plague in adult and pediatric patients (1.7), 8 Chronic Bacterial Prostatitis (1.8), 9 Lower Respiratory Tract Infections (1.9) Acute exacerbation of chronic bronchitis, 10 Urinary Tract Infections (1.10) Urinary Tract Infections (UTI)Complicated UTI and Pyelonephritis in Pediatric Patients, 11 Acute Sinusitis (1.11).</IndicationAndUsage>
<Description>Ciprofloxacin Injection is a synthetic antimicrobial agent for intravenous (IV) administration. Ciprofloxacin, a fluoroquinolone, is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its chemical structure is. Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 331.4. It is soluble in dilute (0.1N) hydrochloric acid and is practically insoluble in water and ethanol. Ciprofloxacin is available as a 2 mg/mL ready-for-use infusion solution in 5% Dextrose Injection. The formula contains lactic acid as a solubilizing agent and hydrochloric acid for pH adjustment. The pH range for the solution is 3.5 to 4.6. The flexible plastic container is latex-free and is fabricated from a specially formulated polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, for example, di(2-ethylhexyl) phthalate (DEHP), up to 5 parts per million. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0409-6533-21</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0409-6533-21) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0409-6533-11) </PackageDescription>
<NDC11Code>00409-6533-21</NDC11Code>
<ProductNDC>0409-6533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062912</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection and other antibacterial drugs, vancomycin hydrochloride for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin hydrochloride for injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg, 750 mg, 1 g or 1.5 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol, 750 mg of the base are equivalent to 0.51 mmol, 1 g of the base are equivalent to 0.67 mmol and 1.5 g of the base are equivalent to 1.01 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S- [3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 ∙ HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0409-6729-03</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0409-6729-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0409-6729-21) </PackageDescription>
<NDC11Code>00409-6729-03</NDC11Code>
<ProductNDC>0409-6729</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Magnesium Sulfate In Water</ProprietaryName>
<NonProprietaryName>Magnesium Sulfate In Water</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050822</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020309</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050822</StartMarketingDatePackage>
<EndMarketingDatePackage>20240201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
<Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4 7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>0409-7332-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0409-7332-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (0409-7332-21) </PackageDescription>
<NDC11Code>00409-7332-20</NDC11Code>
<ProductNDC>0409-7332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ceftriaxone Sodium</ProprietaryName>
<NonProprietaryName>Ceftriaxone Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20050509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065169</ApplicationNumber>
<LabelerName>Hospira, Inc</LabelerName>
<SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms.</IndicationAndUsage>
<Description>Ceftriaxone for injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R, 7R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S33.5H2O. It has a calculated molecular weight of 661.60 and the following structural formula. Ceftriaxone sodium is a white to yellowish crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams of ceftriaxone activity. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.</Description>
</NDC>
</NDCList>