{
"NDC": [
{
"NDCCode": "0409-4053-03",
"PackageDescription": "25 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-4053-03) > 2 mL in 1 VIAL, PATENT DELIVERY SYSTEM",
"NDC11Code": "00409-4053-03",
"ProductNDC": "0409-4053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062801",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "37662-4053-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-4053-3) ",
"NDC11Code": "37662-4053-03",
"ProductNDC": "37662-4053",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stannum Phosphoricum",
"NonProprietaryName": "Stannum Phosphoricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "STANNIC HYDROGEN PHOSPHATE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N"
},
{
"NDCCode": "51672-4053-3",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-3) ",
"NDC11Code": "51672-4053-03",
"ProductNDC": "51672-4053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20030313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076174",
"LabelerName": "TaSun Pharmaceutical Industries, Inc.",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030313",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated: 1 For relief of signs and symptoms of juvenile arthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For relief of the signs and symptoms of osteoarthritis.",
"Description": "Etodolac Extended-Release Tablets contain etodolac, which is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water, but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight is 287.37. Its molecular formula is C 17H 21NO 3and it has the following structural formula:. The inactive ingredients in etodolac extended-release tablets include: HPMC 2910, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, PEG 8000, polydextrose FCC, povidone, titanium dioxide and triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain yellow iron oxide. Meets USP Dissolution Test 4."
},
{
"NDCCode": "62670-4053-3",
"PackageDescription": "263 g in 1 BOTTLE, PUMP (62670-4053-3)",
"NDC11Code": "62670-4053-03",
"ProductNDC": "62670-4053",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Gentle Foaming Hand",
"ProprietaryNameSuffix": "Green Apple Candy",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110711",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "68071-4053-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-4053-3) ",
"NDC11Code": "68071-4053-03",
"ProductNDC": "68071-4053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077836",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170816",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.",
"Description": "Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: calcium stearate NF, carnauba wax NF, colloidal silicon dioxide NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, microcrystalline cellulose NF, polyethylene glycol 3350 NF, polyvinyl alcohol USP, pregelatinized starch NF, sodium lauryl sulfate NF, talc USP and titanium dioxide USP. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C 15H 22O 3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "68788-4053-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68788-4053-3) ",
"NDC11Code": "68788-4053-03",
"ProductNDC": "68788-4053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213412",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251117",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.",
"Description": "Chlorthalidone is an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-chloro-5(1- hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: Colloidal silicon dioxide, D & C Yellow No.10 Aluminum Lake, Microcrystalline cellulose, Pregelatinized starch (maize), Sodium starch glycolate (Type A), Stearic acid. The 50 mg tablets also contain FD&C Blue No.1."
},
{
"NDCCode": "72934-4053-3",
"PackageDescription": "60 g in 1 BOTTLE, PUMP (72934-4053-3) ",
"NDC11Code": "72934-4053-03",
"ProductNDC": "72934-4053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin 1% / Niacinamide 4% / Tretinoin 0.025%",
"NonProprietaryName": "Clindamycin 1% / Niacinamide 4% / Tretinoin 0.025%",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190507",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "NIACINAMIDE; TRETINOIN; CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "4; .25; 1",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190507",
"SamplePackage": "N"
},
{
"NDCCode": "0338-0409-03",
"PackageDescription": "18 BAG in 1 CARTON (0338-0409-03) / 500 mL in 1 BAG",
"NDC11Code": "00338-0409-03",
"ProductNDC": "0338-0409",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Dextrose",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19810422",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018461",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19810422",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine hydrochloride administered intravenously is specifically indicated in the acute management of (1) ventricular arrhythmias occurring during cardiac manipulations, such as cardiac surgery and (2) life-threatening arrhythmias which are ventricular in origin, such as occur during acute myocardial infarction.",
"Description": "Lidocaine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection. It contains no antimicrobial agents. Lidocaine hydrochloride is designated chemically as 2-(Diethylamino) - 2', 6' - acetoxylidide monohydrochloride. The solution serves as a cardiac antiarrhythmic agent intended for intravenous use. Composition, osmolarity, pH and caloric content are shown in Table 1. The pH is adjusted with sodium hydroxide. This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride. Viaflex Plus on the container indicates the presence of a drug additive in a drug vehicle. The Viaflex Plus plastic container system utilizes the same container as the Viaflex plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological standards for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0409-0021-03",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0021-03) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0021-03",
"ProductNDC": "0409-0021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pemetrexed",
"NonProprietaryName": "Pemetrexed",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214218",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "PEMETREXED DISODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230201",
"SamplePackage": "N",
"IndicationAndUsage": "Pemetrexed Injection is a folate analog metabolic inhibitor indicated: 1 In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1), 2 As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 3 As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1), 4 Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1), 5 Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2).",
"Description": "Pemetrexed is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium (2.5 H2O), has the chemical name N-[[4-[2-(2-Amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]phenyl]carbonyl]-L-glutamic acid disodium, hemipentahydrate with a molecular formula of C20H19N5Na2O6 ∙2.5H2O and a molecular weight of 516.41. The structural formula is as follows. Pemetrexed Injection, 100 mg/4 mL, 500 mg/20 mL, and 1 g/40 mL are supplied as a sterile, preservative-free, clear, colorless to pale yellow ready-to-dilute solution in a single-dose vial for intravenous infusion. Each milliliter (mL) contains 25 mg pemetrexed (equivalent to 27.57 mg pemetrexed disodium), 1.2 mg monothioglycerol, water for injection and may contain sodium hydroxide for pH adjustment."
},
{
"NDCCode": "0409-0212-03",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0212-03) / 50 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0212-03",
"ProductNDC": "0409-0212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Milrinone Lactate",
"NonProprietaryName": "Milrinone Lactate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203280",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MILRINONE LACTATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150331",
"SamplePackage": "N",
"IndicationAndUsage": "Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.",
"Description": "Milrinone Lactate Injection, is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-Dihydro-2-methyl-6-oxo[3,4'-bipyridine]-5-carbonitrile lactate and has the following structural formula. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate injection is available as a sterile aqueous solution of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials: Single-dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous in Water for Injection. The pH is adjusted to between 3.2 and 4.0 with lactic acid and/or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously."
},
{
"NDCCode": "0409-0806-03",
"PackageDescription": "10 BOTTLE in 1 CARTON (0409-0806-03) > 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE",
"NDC11Code": "00409-0806-03",
"ProductNDC": "0409-0806",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefazolin",
"NonProprietaryName": "Cefazolin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065247",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CEFAZOLIN SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0409-1134-03",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1134-03) > 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-1134-03",
"ProductNDC": "0409-1134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050811",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050927",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate is indicated for the relief of severe pain. It is used preoperatively to sedate the patient and allay apprehension, facilitate anesthesia induction and reduce anesthetic dosage. It is likewise effective in the control of post-operative pain. The use of morphine for the relief of pain should be reserved for the more severe manifestations of pain, as in myocardial infarction, severe injuries, or in severe chronic pain associated with terminal cancer after all non-narcotic analgesics have failed. Effective analgesic therapy of severe chronic pain associated with terminal cancer continues to be a difficult problem. Intermittent administration of intramuscular morphine may be effective; however, the mode of therapy has significant limitations. Morphine has a short plasma half-life of 2.5 to 3.0 hours; therefore, frequent administration (every 1 to 2 hours) often becomes necessary to control severe pain associated with cancer. Tolerance develops to the analgesic effects and increasingly higher doses of morphine are required to produce analgesia. The higher morphine doses produce significant and often life-threatening side effects (see ADVERSE REACTIONS). The peak and trough effects produced by intermittent administration cause fluctuations in pain control. Repeated intramuscular injections are frequently unacceptable due to the lack of muscle mass in the debilitated patient, the tendency for bruising and bleeding at the injection site, and the anxiety and pain associated with the injection. Continuous intravenous infusion of morphine (see DOSAGE AND ADMINISTRATION) has been employed as an alternative to traditional modes of administration. Lower doses of morphine produce uniform pain control because a steady morphine concentration is maintained. Titration of the dosage to the patient's needs is easily achieved by adjusting the infusion rate. The lag time between the patient's request for pain medication and administration of the dose and the amount of nursing time necessary for preparation and administration of frequent doses are reduced. The degree of respiratory depression and sedation may be decreased, and the anxiety experienced by the patient in anticipation of intramuscular administration is avoided. Some Investigators feel that tolerance to the analgesic effects may develop more slowly with continuous intravenous infusion. In addition to analgesia, the drug may relieve anxiety and reduce left ventricular work by reducing preload pressure. Morphine is also used in the therapy of dyspnea associated with acute left ventricular and pulmonary edema. Care must be taken to avoid inducing respiratory depression in such patients. For open-heart surgery, especially in high risk patients with cardiac disease, some anesthesiologists use morphine to produce anesthesia.",
"Description": "Morphine is a tertiary nitrogen base containing a phenanthrene nucleus; it has two hydroxyl groups, one phenolic and the other alcoholic (secondary). The sulfate salt occurs as white, feathery, silky crystals, cubical masses of crystals, or white, crystalline powder. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt), pentahydrate. It has the following chemical structure. Morphine Sulfate Injection, USP is a sterile solution of morphine sulfate pentahydrate in Water for Injection, USP. Morphine Sulfate Injection, USP is available in the following concentrations. Each mL of Morphine Sulfate Injection, USP, Preservative Free (no bacteriostat or antioxidant added) contains 25 mg Morphine Sulfate in Water for Injection. Sulfuric acid added for adjustment of pH to 3.5 (2.5 to 6.5). Each mL of Morphine Sulfate Injection, USP, (no bacteriostat added), contains 25 mg or 50 mg Morphine Sulfate, 0.75 mg Edetate Disodium, 1 mg Sodium Metabisulfite (added during manufacture) as an antioxidant, in Water for Injection. Sulfuric acid added for adjustment of pH to 3.5 (2.5 to 6.5). NOTE: These products are intended for intravenous use only. They are not intended for intrathecal or epidural use. They are for use after dilution, not for direct infusion, and is intended as a single-dose unit. It contains no antimicrobial preservatives. When the dosing requirement is completed, the unused portion should be discarded in an appropriate manner."
},
{
"NDCCode": "0409-1176-30",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1176-30) / 1 mL in 1 CARTRIDGE (0409-1176-03) ",
"NDC11Code": "00409-1176-30",
"ProductNDC": "0409-1176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Demerol",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050825",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021171",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050825",
"SamplePackage": "N",
"IndicationAndUsage": "DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C."
},
{
"NDCCode": "0409-1178-30",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1178-30) / 1 mL in 1 CARTRIDGE (0409-1178-03) ",
"NDC11Code": "00409-1178-30",
"ProductNDC": "0409-1178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Demerol",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050913",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021171",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050913",
"SamplePackage": "N",
"IndicationAndUsage": "DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C."
},
{
"NDCCode": "0409-1179-30",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1179-30) / 1 mL in 1 CARTRIDGE (0409-1179-03) ",
"NDC11Code": "00409-1179-30",
"ProductNDC": "0409-1179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Demerol",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20051012",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021171",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051012",
"SamplePackage": "N",
"IndicationAndUsage": "DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C."
},
{
"NDCCode": "0409-1207-03",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1207-03) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-1207-13) ",
"NDC11Code": "00409-1207-03",
"ProductNDC": "0409-1207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentamicin Sulfate",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062420",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "GENTAMICIN SULFATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050829",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin 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. Gentamicin Sulfate Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown Gentamicin Sulfate Injection, USP to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. Gentamicin sulfate may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the WARNINGS box. If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. In serious infections when the causative organisms are unknown, gentamicin sulfate may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. Gentamicin sulfate has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci. Gentamicin Sulfate Injection, USP has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.",
"Description": "Gentamicin Sulfate Injection, USP is a sterile, nonpyrogenic solution of gentamicin sulfate in water for injection. It is administered by the intramuscular or intravenous route. Each milliliter (mL) contains gentamicin sulfate equivalent to 40 mg gentamicin base with sodium metabisulfite 2.9 mg and edetate disodium anhydrous 0.1 mg added as stabilizer, methylparaben 1.8 mg and propylparaben 0.2 mg added as preservatives. Headspace nitrogen gassed. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 3.8 (3.0 to 5.5). Gentamicin is classified as an aminoglycoside antibiotic and is derived from Micromonospora purpurea, an actinomycete. The chemical name for gentamicin C1A is: 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine. Gentamicin Sulfate, USP is chemically designated gentamicin sulfate, a white to buff powder soluble in water. It has the following structural formula."
},
{
"NDCCode": "0409-1273-32",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1273-32) / 2 mL in 1 CARTRIDGE (0409-1273-03) ",
"NDC11Code": "00409-1273-32",
"ProductNDC": "0409-1273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072079",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050823",
"SamplePackage": "N",
"IndicationAndUsage": "Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures (see WARNINGS). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam Injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.",
"Description": "Diazepam Injection, USP is a sterile, nonpyrogenic solution intended for intramuscular or intravenous administration. Each milliliter (mL) contains 5 mg diazepam; 40% propylene glycol; 10% alcohol; 5% sodium benzoate and benzoic acid added as buffers; and 1.5% benzyl alcohol added as a preservative. pH 6.6 (6.2 to 6.9). Note: Solution may appear colorless to light yellow. Diazepam is a benzodiazepine derivative chemically designated as 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with a molecular weight of 284.74 and with the following molecular structure."
},
{
"NDCCode": "0409-1276-32",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1276-32) / 2 mL in 1 CARTRIDGE (0409-1276-03) ",
"NDC11Code": "00409-1276-32",
"ProductNDC": "0409-1276",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072786",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20050720",
"SamplePackage": "N"
},
{
"NDCCode": "0409-1283-31",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1283-31) / 1 mL in 1 CARTRIDGE (0409-1283-03) ",
"NDC11Code": "00409-1283-31",
"ProductNDC": "0409-1283",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200403",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. ."
},
{
"NDCCode": "0409-1304-31",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1304-31) / 1 mL in 1 CARTRIDGE (0409-1304-03) ",
"NDC11Code": "00409-1304-31",
"ProductNDC": "0409-1304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200403",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. ."
},
{
"NDCCode": "0409-1312-30",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1312-30) / 1 mL in 1 CARTRIDGE (0409-1312-03) ",
"NDC11Code": "00409-1312-30",
"ProductNDC": "0409-1312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200403",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. ."
},
{
"NDCCode": "0409-1442-03",
"PackageDescription": "10 AMPULE in 1 CARTON (0409-1442-03) > 5 mL in 1 AMPULE",
"NDC11Code": "00409-1442-03",
"ProductNDC": "0409-1442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isuprel",
"NonProprietaryName": "Isoproterenol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20130321",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA010515",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOPROTERENOL HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-1483-03",
"PackageDescription": "500 mL in 1 BOTTLE, GLASS (0409-1483-03)",
"NDC11Code": "00409-1483-03",
"ProductNDC": "0409-1483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin In Dextrose",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071846",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "100",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-10-16"
},
{
"NDCCode": "0409-1484-03",
"PackageDescription": "500 mL in 1 BOTTLE, GLASS (0409-1484-03)",
"NDC11Code": "00409-1484-03",
"ProductNDC": "0409-1484",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin In Dextrose",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071848",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "400",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-10-16"
},
{
"NDCCode": "0409-1539-31",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1539-31) > 1 mL in 1 CARTRIDGE (0409-1539-03) ",
"NDC11Code": "00409-1539-31",
"ProductNDC": "0409-1539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20051228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074243",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20051228",
"SamplePackage": "N"
},
{
"NDCCode": "0409-1749-03",
"PackageDescription": "10 AMPULE in 1 CARTON (0409-1749-03) > 3 mL in 1 AMPULE",
"NDC11Code": "00409-1749-03",
"ProductNDC": "0409-1749",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Marcaine With Epinephrine",
"NonProprietaryName": "Bupivacaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION",
"StartMarketingDate": "20100510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016964",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "5; .0091",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-07-28"
},
{
"NDCCode": "0409-1782-69",
"PackageDescription": "10 CARTRIDGE in 1 BOX (0409-1782-69) / 1 mL in 1 CARTRIDGE (0409-1782-03) ",
"NDC11Code": "00409-1782-69",
"ProductNDC": "0409-1782",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070172",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050923",
"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 hydrochloride injection 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, an opioid antagonist, is a synthetic congener of oxymorphone. In structure it differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. It is known chemically as 17-allyl-4,5α-epoxy,3-14-dihydroxymorphinan-6-one hydrochloride. It has a molecular weight of 363.84, and the following structural formula. Naloxone hydrochloride occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform. Naloxone hydrochloride injection is available as a sterile solution for intravenous, intramuscular, and subcutaneous administration. Each mL contains 0.4 mg of naloxone hydrochloride. Each mL contains 8.9 mg of sodium chloride. The pH is adjusted between 3.0 to 6.5 with hydrochloric acid or sodium hydroxide. The air in the cartridges has been displaced by nitrogen gas."
},
{
"NDCCode": "0409-1890-01",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1890-01) / 1 mL in 1 CARTRIDGE (0409-1890-03) ",
"NDC11Code": "00409-1890-01",
"ProductNDC": "0409-1890",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202515",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120823",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Morphine Sulfate Injection, USP is an opioid agonist, available in 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, and 15 mg/mL (1 mL fill in 2.5 mL Carpuject Single‑dose cartridge with Luer Lock for the Carpuject Syringe System) and 2 mg/mL, 4 mg/mL, 8 mg/mL, and 10 mg/mL (1 mL fill in 1.5 mL NexJect Single-dose Prefilled Syringe with Luer Lock). When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light. The chemical name is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2: 1) (salt), pentahydrate, with the following chemical structure. (C17H19NO3)2 H2SO4 5H2O Molecular Weight is 758.83. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). Morphine Sulfate Injection, USP is a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives to be administered by the intravenous route. For the single-dose Carpuject cartridges for intravenous administration: Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, 10 mg, or 15 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg and 10 mg Morphine Sulfate Injection, USP or 0.8 mg citric acid for the 15 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0. For the single-dose NexJect syringes for intravenous administration: Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, or 10 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg, and 10 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0."
},
{
"NDCCode": "0409-1891-01",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1891-01) / 1 mL in 1 CARTRIDGE (0409-1891-03) ",
"NDC11Code": "00409-1891-01",
"ProductNDC": "0409-1891",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120807",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202515",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120807",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Morphine Sulfate Injection, USP is an opioid agonist, available in 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, and 15 mg/mL (1 mL fill in 2.5 mL Carpuject Single‑dose cartridge with Luer Lock for the Carpuject Syringe System) and 2 mg/mL, 4 mg/mL, 8 mg/mL, and 10 mg/mL (1 mL fill in 1.5 mL NexJect Single-dose Prefilled Syringe with Luer Lock). When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light. The chemical name is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2: 1) (salt), pentahydrate, with the following chemical structure. (C17H19NO3)2 H2SO4 5H2O Molecular Weight is 758.83. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). Morphine Sulfate Injection, USP is a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives to be administered by the intravenous route. For the single-dose Carpuject cartridges for intravenous administration: Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, 10 mg, or 15 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg and 10 mg Morphine Sulfate Injection, USP or 0.8 mg citric acid for the 15 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0. For the single-dose NexJect syringes for intravenous administration: Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, or 10 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg, and 10 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0."
},
{
"NDCCode": "0409-1892-01",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1892-01) / 1 mL in 1 CARTRIDGE (0409-1892-03) ",
"NDC11Code": "00409-1892-01",
"ProductNDC": "0409-1892",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120924",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202515",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "8",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120924",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Morphine Sulfate Injection, USP is an opioid agonist, available in 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, and 15 mg/mL (1 mL fill in 2.5 mL Carpuject Single‑dose cartridge with Luer Lock for the Carpuject Syringe System) and 2 mg/mL, 4 mg/mL, 8 mg/mL, and 10 mg/mL (1 mL fill in 1.5 mL NexJect Single-dose Prefilled Syringe with Luer Lock). When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light. The chemical name is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2: 1) (salt), pentahydrate, with the following chemical structure. (C17H19NO3)2 . H2SO4 . 5H2O Molecular Weight is 758.83. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). Morphine Sulfate Injection, USP is a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives to be administered by the intravenous route. For the single-dose Carpuject cartridges for intravenous administration. Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, 10 mg, or 15 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg and 10 mg Morphine Sulfate Injection, USP or 0.8 mg citric acid for the 15 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0. For the single-dose NexJect syringes for intravenous administration: Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, or 10 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg, and 10 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0409-4053-03</NDCCode>
<PackageDescription>25 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-4053-03) > 2 mL in 1 VIAL, PATENT DELIVERY SYSTEM</PackageDescription>
<NDC11Code>00409-4053-03</NDC11Code>
<ProductNDC>0409-4053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19870724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062801</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>37662-4053-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-4053-3) </PackageDescription>
<NDC11Code>37662-4053-03</NDC11Code>
<ProductNDC>37662-4053</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stannum Phosphoricum</ProprietaryName>
<NonProprietaryName>Stannum Phosphoricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230928</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>STANNIC HYDROGEN PHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51672-4053-3</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-3) </PackageDescription>
<NDC11Code>51672-4053-03</NDC11Code>
<ProductNDC>51672-4053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076174</ApplicationNumber>
<LabelerName>TaSun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated: 1 For relief of signs and symptoms of juvenile arthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For relief of the signs and symptoms of osteoarthritis.</IndicationAndUsage>
<Description>Etodolac Extended-Release Tablets contain etodolac, which is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water, but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight is 287.37. Its molecular formula is C 17H 21NO 3and it has the following structural formula:. The inactive ingredients in etodolac extended-release tablets include: HPMC 2910, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, PEG 8000, polydextrose FCC, povidone, titanium dioxide and triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain yellow iron oxide. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>62670-4053-3</NDCCode>
<PackageDescription>263 g in 1 BOTTLE, PUMP (62670-4053-3)</PackageDescription>
<NDC11Code>62670-4053-03</NDC11Code>
<ProductNDC>62670-4053</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Gentle Foaming Hand</ProprietaryName>
<ProprietaryNameSuffix>Green Apple Candy</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110711</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>68071-4053-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-4053-3) </PackageDescription>
<NDC11Code>68071-4053-03</NDC11Code>
<ProductNDC>68071-4053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077836</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: calcium stearate NF, carnauba wax NF, colloidal silicon dioxide NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, microcrystalline cellulose NF, polyethylene glycol 3350 NF, polyvinyl alcohol USP, pregelatinized starch NF, sodium lauryl sulfate NF, talc USP and titanium dioxide USP. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C 15H 22O 3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>68788-4053-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68788-4053-3) </PackageDescription>
<NDC11Code>68788-4053-03</NDC11Code>
<ProductNDC>68788-4053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213412</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.</IndicationAndUsage>
<Description>Chlorthalidone is an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-chloro-5(1- hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: Colloidal silicon dioxide, D & C Yellow No.10 Aluminum Lake, Microcrystalline cellulose, Pregelatinized starch (maize), Sodium starch glycolate (Type A), Stearic acid. The 50 mg tablets also contain FD&C Blue No.1.</Description>
</NDC>
<NDC>
<NDCCode>72934-4053-3</NDCCode>
<PackageDescription>60 g in 1 BOTTLE, PUMP (72934-4053-3) </PackageDescription>
<NDC11Code>72934-4053-03</NDC11Code>
<ProductNDC>72934-4053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin 1% / Niacinamide 4% / Tretinoin 0.025%</ProprietaryName>
<NonProprietaryName>Clindamycin 1% / Niacinamide 4% / Tretinoin 0.025%</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>NIACINAMIDE; TRETINOIN; CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>4; .25; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0338-0409-03</NDCCode>
<PackageDescription>18 BAG in 1 CARTON (0338-0409-03) / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-0409-03</NDC11Code>
<ProductNDC>0338-0409</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Dextrose</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19810422</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018461</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine hydrochloride administered intravenously is specifically indicated in the acute management of (1) ventricular arrhythmias occurring during cardiac manipulations, such as cardiac surgery and (2) life-threatening arrhythmias which are ventricular in origin, such as occur during acute myocardial infarction.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection. It contains no antimicrobial agents. Lidocaine hydrochloride is designated chemically as 2-(Diethylamino) - 2', 6' - acetoxylidide monohydrochloride. The solution serves as a cardiac antiarrhythmic agent intended for intravenous use. Composition, osmolarity, pH and caloric content are shown in Table 1. The pH is adjusted with sodium hydroxide. This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride. Viaflex Plus on the container indicates the presence of a drug additive in a drug vehicle. The Viaflex Plus plastic container system utilizes the same container as the Viaflex plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological standards for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0409-0021-03</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0021-03) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0021-03</NDC11Code>
<ProductNDC>0409-0021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pemetrexed</ProprietaryName>
<NonProprietaryName>Pemetrexed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214218</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>PEMETREXED DISODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pemetrexed Injection is a folate analog metabolic inhibitor indicated: 1 In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1), 2 As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 3 As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1), 4 Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1), 5 Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2).</IndicationAndUsage>
<Description>Pemetrexed is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium (2.5 H2O), has the chemical name N-[[4-[2-(2-Amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]phenyl]carbonyl]-L-glutamic acid disodium, hemipentahydrate with a molecular formula of C20H19N5Na2O6 ∙2.5H2O and a molecular weight of 516.41. The structural formula is as follows. Pemetrexed Injection, 100 mg/4 mL, 500 mg/20 mL, and 1 g/40 mL are supplied as a sterile, preservative-free, clear, colorless to pale yellow ready-to-dilute solution in a single-dose vial for intravenous infusion. Each milliliter (mL) contains 25 mg pemetrexed (equivalent to 27.57 mg pemetrexed disodium), 1.2 mg monothioglycerol, water for injection and may contain sodium hydroxide for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>0409-0212-03</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0212-03) / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0212-03</NDC11Code>
<ProductNDC>0409-0212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Milrinone Lactate</ProprietaryName>
<NonProprietaryName>Milrinone Lactate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203280</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MILRINONE LACTATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.</IndicationAndUsage>
<Description>Milrinone Lactate Injection, is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-Dihydro-2-methyl-6-oxo[3,4'-bipyridine]-5-carbonitrile lactate and has the following structural formula. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate injection is available as a sterile aqueous solution of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials: Single-dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous in Water for Injection. The pH is adjusted to between 3.2 and 4.0 with lactic acid and/or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously.</Description>
</NDC>
<NDC>
<NDCCode>0409-0806-03</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (0409-0806-03) > 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE</PackageDescription>
<NDC11Code>00409-0806-03</NDC11Code>
<ProductNDC>0409-0806</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefazolin</ProprietaryName>
<NonProprietaryName>Cefazolin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065247</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-1134-03</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1134-03) > 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-1134-03</NDC11Code>
<ProductNDC>0409-1134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050811</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate is indicated for the relief of severe pain. It is used preoperatively to sedate the patient and allay apprehension, facilitate anesthesia induction and reduce anesthetic dosage. It is likewise effective in the control of post-operative pain. The use of morphine for the relief of pain should be reserved for the more severe manifestations of pain, as in myocardial infarction, severe injuries, or in severe chronic pain associated with terminal cancer after all non-narcotic analgesics have failed. Effective analgesic therapy of severe chronic pain associated with terminal cancer continues to be a difficult problem. Intermittent administration of intramuscular morphine may be effective; however, the mode of therapy has significant limitations. Morphine has a short plasma half-life of 2.5 to 3.0 hours; therefore, frequent administration (every 1 to 2 hours) often becomes necessary to control severe pain associated with cancer. Tolerance develops to the analgesic effects and increasingly higher doses of morphine are required to produce analgesia. The higher morphine doses produce significant and often life-threatening side effects (see ADVERSE REACTIONS). The peak and trough effects produced by intermittent administration cause fluctuations in pain control. Repeated intramuscular injections are frequently unacceptable due to the lack of muscle mass in the debilitated patient, the tendency for bruising and bleeding at the injection site, and the anxiety and pain associated with the injection. Continuous intravenous infusion of morphine (see DOSAGE AND ADMINISTRATION) has been employed as an alternative to traditional modes of administration. Lower doses of morphine produce uniform pain control because a steady morphine concentration is maintained. Titration of the dosage to the patient's needs is easily achieved by adjusting the infusion rate. The lag time between the patient's request for pain medication and administration of the dose and the amount of nursing time necessary for preparation and administration of frequent doses are reduced. The degree of respiratory depression and sedation may be decreased, and the anxiety experienced by the patient in anticipation of intramuscular administration is avoided. Some Investigators feel that tolerance to the analgesic effects may develop more slowly with continuous intravenous infusion. In addition to analgesia, the drug may relieve anxiety and reduce left ventricular work by reducing preload pressure. Morphine is also used in the therapy of dyspnea associated with acute left ventricular and pulmonary edema. Care must be taken to avoid inducing respiratory depression in such patients. For open-heart surgery, especially in high risk patients with cardiac disease, some anesthesiologists use morphine to produce anesthesia.</IndicationAndUsage>
<Description>Morphine is a tertiary nitrogen base containing a phenanthrene nucleus; it has two hydroxyl groups, one phenolic and the other alcoholic (secondary). The sulfate salt occurs as white, feathery, silky crystals, cubical masses of crystals, or white, crystalline powder. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt), pentahydrate. It has the following chemical structure. Morphine Sulfate Injection, USP is a sterile solution of morphine sulfate pentahydrate in Water for Injection, USP. Morphine Sulfate Injection, USP is available in the following concentrations. Each mL of Morphine Sulfate Injection, USP, Preservative Free (no bacteriostat or antioxidant added) contains 25 mg Morphine Sulfate in Water for Injection. Sulfuric acid added for adjustment of pH to 3.5 (2.5 to 6.5). Each mL of Morphine Sulfate Injection, USP, (no bacteriostat added), contains 25 mg or 50 mg Morphine Sulfate, 0.75 mg Edetate Disodium, 1 mg Sodium Metabisulfite (added during manufacture) as an antioxidant, in Water for Injection. Sulfuric acid added for adjustment of pH to 3.5 (2.5 to 6.5). NOTE: These products are intended for intravenous use only. They are not intended for intrathecal or epidural use. They are for use after dilution, not for direct infusion, and is intended as a single-dose unit. It contains no antimicrobial preservatives. When the dosing requirement is completed, the unused portion should be discarded in an appropriate manner.</Description>
</NDC>
<NDC>
<NDCCode>0409-1176-30</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1176-30) / 1 mL in 1 CARTRIDGE (0409-1176-03) </PackageDescription>
<NDC11Code>00409-1176-30</NDC11Code>
<ProductNDC>0409-1176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Demerol</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050825</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021171</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C.</Description>
</NDC>
<NDC>
<NDCCode>0409-1178-30</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1178-30) / 1 mL in 1 CARTRIDGE (0409-1178-03) </PackageDescription>
<NDC11Code>00409-1178-30</NDC11Code>
<ProductNDC>0409-1178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Demerol</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050913</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021171</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C.</Description>
</NDC>
<NDC>
<NDCCode>0409-1179-30</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1179-30) / 1 mL in 1 CARTRIDGE (0409-1179-03) </PackageDescription>
<NDC11Code>00409-1179-30</NDC11Code>
<ProductNDC>0409-1179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Demerol</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20051012</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021171</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C.</Description>
</NDC>
<NDC>
<NDCCode>0409-1207-03</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1207-03) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-1207-13) </PackageDescription>
<NDC11Code>00409-1207-03</NDC11Code>
<ProductNDC>0409-1207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentamicin Sulfate</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20050829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062420</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>GENTAMICIN SULFATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin 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. Gentamicin Sulfate Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown Gentamicin Sulfate Injection, USP to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. Gentamicin sulfate may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the WARNINGS box. If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. In serious infections when the causative organisms are unknown, gentamicin sulfate may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. Gentamicin sulfate has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci. Gentamicin Sulfate Injection, USP has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.</IndicationAndUsage>
<Description>Gentamicin Sulfate Injection, USP is a sterile, nonpyrogenic solution of gentamicin sulfate in water for injection. It is administered by the intramuscular or intravenous route. Each milliliter (mL) contains gentamicin sulfate equivalent to 40 mg gentamicin base with sodium metabisulfite 2.9 mg and edetate disodium anhydrous 0.1 mg added as stabilizer, methylparaben 1.8 mg and propylparaben 0.2 mg added as preservatives. Headspace nitrogen gassed. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 3.8 (3.0 to 5.5). Gentamicin is classified as an aminoglycoside antibiotic and is derived from Micromonospora purpurea, an actinomycete. The chemical name for gentamicin C1A is: 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine. Gentamicin Sulfate, USP is chemically designated gentamicin sulfate, a white to buff powder soluble in water. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0409-1273-32</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1273-32) / 2 mL in 1 CARTRIDGE (0409-1273-03) </PackageDescription>
<NDC11Code>00409-1273-32</NDC11Code>
<ProductNDC>0409-1273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20050823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072079</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures (see WARNINGS). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam Injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.</IndicationAndUsage>
<Description>Diazepam Injection, USP is a sterile, nonpyrogenic solution intended for intramuscular or intravenous administration. Each milliliter (mL) contains 5 mg diazepam; 40% propylene glycol; 10% alcohol; 5% sodium benzoate and benzoic acid added as buffers; and 1.5% benzyl alcohol added as a preservative. pH 6.6 (6.2 to 6.9). Note: Solution may appear colorless to light yellow. Diazepam is a benzodiazepine derivative chemically designated as 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with a molecular weight of 284.74 and with the following molecular structure.</Description>
</NDC>
<NDC>
<NDCCode>0409-1276-32</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1276-32) / 2 mL in 1 CARTRIDGE (0409-1276-03) </PackageDescription>
<NDC11Code>00409-1276-32</NDC11Code>
<ProductNDC>0409-1276</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20050720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072786</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>FENTANYL 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>2023-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-1283-31</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1283-31) / 1 mL in 1 CARTRIDGE (0409-1283-03) </PackageDescription>
<NDC11Code>00409-1283-31</NDC11Code>
<ProductNDC>0409-1283</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. .</Description>
</NDC>
<NDC>
<NDCCode>0409-1304-31</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1304-31) / 1 mL in 1 CARTRIDGE (0409-1304-03) </PackageDescription>
<NDC11Code>00409-1304-31</NDC11Code>
<ProductNDC>0409-1304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. .</Description>
</NDC>
<NDC>
<NDCCode>0409-1312-30</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1312-30) / 1 mL in 1 CARTRIDGE (0409-1312-03) </PackageDescription>
<NDC11Code>00409-1312-30</NDC11Code>
<ProductNDC>0409-1312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. .</Description>
</NDC>
<NDC>
<NDCCode>0409-1442-03</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (0409-1442-03) > 5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00409-1442-03</NDC11Code>
<ProductNDC>0409-1442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isuprel</ProprietaryName>
<NonProprietaryName>Isoproterenol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130321</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA010515</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOPROTERENOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-1483-03</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, GLASS (0409-1483-03)</PackageDescription>
<NDC11Code>00409-1483-03</NDC11Code>
<ProductNDC>0409-1483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin In Dextrose</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071846</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-1484-03</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, GLASS (0409-1484-03)</PackageDescription>
<NDC11Code>00409-1484-03</NDC11Code>
<ProductNDC>0409-1484</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin In Dextrose</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071848</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-1539-31</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1539-31) > 1 mL in 1 CARTRIDGE (0409-1539-03) </PackageDescription>
<NDC11Code>00409-1539-31</NDC11Code>
<ProductNDC>0409-1539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20051228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074243</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-1749-03</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (0409-1749-03) > 3 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00409-1749-03</NDC11Code>
<ProductNDC>0409-1749</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Marcaine With Epinephrine</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION</RouteName>
<StartMarketingDate>20100510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016964</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>5; .0091</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-1782-69</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 BOX (0409-1782-69) / 1 mL in 1 CARTRIDGE (0409-1782-03) </PackageDescription>
<NDC11Code>00409-1782-69</NDC11Code>
<ProductNDC>0409-1782</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070172</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>2023-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050923</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 hydrochloride injection 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, an opioid antagonist, is a synthetic congener of oxymorphone. In structure it differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. It is known chemically as 17-allyl-4,5α-epoxy,3-14-dihydroxymorphinan-6-one hydrochloride. It has a molecular weight of 363.84, and the following structural formula. Naloxone hydrochloride occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform. Naloxone hydrochloride injection is available as a sterile solution for intravenous, intramuscular, and subcutaneous administration. Each mL contains 0.4 mg of naloxone hydrochloride. Each mL contains 8.9 mg of sodium chloride. The pH is adjusted between 3.0 to 6.5 with hydrochloric acid or sodium hydroxide. The air in the cartridges has been displaced by nitrogen gas.</Description>
</NDC>
<NDC>
<NDCCode>0409-1890-01</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1890-01) / 1 mL in 1 CARTRIDGE (0409-1890-03) </PackageDescription>
<NDC11Code>00409-1890-01</NDC11Code>
<ProductNDC>0409-1890</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202515</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Morphine Sulfate Injection, USP is an opioid agonist, available in 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, and 15 mg/mL (1 mL fill in 2.5 mL Carpuject Single‑dose cartridge with Luer Lock for the Carpuject Syringe System) and 2 mg/mL, 4 mg/mL, 8 mg/mL, and 10 mg/mL (1 mL fill in 1.5 mL NexJect Single-dose Prefilled Syringe with Luer Lock). When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light. The chemical name is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2: 1) (salt), pentahydrate, with the following chemical structure. (C17H19NO3)2 H2SO4 5H2O Molecular Weight is 758.83. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). Morphine Sulfate Injection, USP is a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives to be administered by the intravenous route. For the single-dose Carpuject cartridges for intravenous administration: Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, 10 mg, or 15 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg and 10 mg Morphine Sulfate Injection, USP or 0.8 mg citric acid for the 15 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0. For the single-dose NexJect syringes for intravenous administration: Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, or 10 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg, and 10 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0.</Description>
</NDC>
<NDC>
<NDCCode>0409-1891-01</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1891-01) / 1 mL in 1 CARTRIDGE (0409-1891-03) </PackageDescription>
<NDC11Code>00409-1891-01</NDC11Code>
<ProductNDC>0409-1891</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120807</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202515</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Morphine Sulfate Injection, USP is an opioid agonist, available in 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, and 15 mg/mL (1 mL fill in 2.5 mL Carpuject Single‑dose cartridge with Luer Lock for the Carpuject Syringe System) and 2 mg/mL, 4 mg/mL, 8 mg/mL, and 10 mg/mL (1 mL fill in 1.5 mL NexJect Single-dose Prefilled Syringe with Luer Lock). When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light. The chemical name is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2: 1) (salt), pentahydrate, with the following chemical structure. (C17H19NO3)2 H2SO4 5H2O Molecular Weight is 758.83. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). Morphine Sulfate Injection, USP is a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives to be administered by the intravenous route. For the single-dose Carpuject cartridges for intravenous administration: Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, 10 mg, or 15 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg and 10 mg Morphine Sulfate Injection, USP or 0.8 mg citric acid for the 15 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0. For the single-dose NexJect syringes for intravenous administration: Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, or 10 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg, and 10 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0.</Description>
</NDC>
<NDC>
<NDCCode>0409-1892-01</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1892-01) / 1 mL in 1 CARTRIDGE (0409-1892-03) </PackageDescription>
<NDC11Code>00409-1892-01</NDC11Code>
<ProductNDC>0409-1892</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120924</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202515</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Morphine Sulfate Injection, USP is an opioid agonist, available in 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, and 15 mg/mL (1 mL fill in 2.5 mL Carpuject Single‑dose cartridge with Luer Lock for the Carpuject Syringe System) and 2 mg/mL, 4 mg/mL, 8 mg/mL, and 10 mg/mL (1 mL fill in 1.5 mL NexJect Single-dose Prefilled Syringe with Luer Lock). When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light. The chemical name is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2: 1) (salt), pentahydrate, with the following chemical structure. (C17H19NO3)2 . H2SO4 . 5H2O Molecular Weight is 758.83. Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). Morphine Sulfate Injection, USP is a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives to be administered by the intravenous route. For the single-dose Carpuject cartridges for intravenous administration. Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, 10 mg, or 15 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg and 10 mg Morphine Sulfate Injection, USP or 0.8 mg citric acid for the 15 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0. For the single-dose NexJect syringes for intravenous administration: Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, or 10 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg, and 10 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0.</Description>
</NDC>
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