RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>0409-0332-20</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0332-20)  &gt; 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00409-0332-20</NDC11Code>
    <ProductNDC>0409-0332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bleomycin</ProprietaryName>
    <NonProprietaryName>Bleomycin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150425</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065031</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>BLEOMYCIN SULFATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>[USP'U]/1</StrengthUnit>
    <Pharm_Classes>Cytoprotective Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180425</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents. Squamous Cell Carcinoma. Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to bleomycin is poorer in patients with previously irradiated head and neck cancer. Lymphomas. Hodgkin's disease, non-Hodgkin's lymphoma. Testicular Carcinoma. Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin has also been shown to be useful in the management of:. Malignant Pleural Effusion Bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.</IndicationAndUsage>
    <Description>Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. It is freely soluble in water. It is available as a lyophilized powder for intramuscular, intravenous or subcutaneous injection. Each vial contains sterile bleomycin sulphate equivalent to 15 units or 30 units of bleomycin. Sulfuric acid or Sodium hydroxide used, if necessary to adjust the pH. Bleomycins are a group of related basic glycopeptides which differ in the terminal amine substituent of the common structural unit, bleomycin acid. The main components of Bleomycin for Injection are bleomycins A2 and B2. Chemically, bleomycin A2 is N1-[3-(dimethylsulfonio)propyl]-bleomycinamide and bleomycin B2 is N1-[4-(aminoiminomethyl)amino]butyl]-bleomycinamide. The molecular formula of bleomycin A2 is C55H84N17O21S3 and a calculated molecular weight of 1414. The molecular formula of bleomycin B2 is C55H84N20O21S2 and a calculated molecular weight of 1425. The structural formula of bleomycins A2 and B2 are shown below. Note: A unit of bleomycin is equal to the formerly used milligram activity. The term milligram activity is a misnomer and was changed to units to be more precise.</Description>
  </NDC>
  <NDC>
    <NDCCode>52125-332-20</NDCCode>
    <PackageDescription>100 TABLET in 1 VIAL (52125-332-20)</PackageDescription>
    <NDC11Code>52125-0332-20</NDC11Code>
    <ProductNDC>52125-332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077829</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58552-332-20</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (58552-332-20)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>58552-0332-20</NDC11Code>
    <ProductNDC>58552-332</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Giltuss Sinus And Chest Congestion</ProprietaryName>
    <NonProprietaryName>Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210401</StartMarketingDate>
    <EndMarketingDate>20270228</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Gil Pharmaceutical Corp</LabelerName>
    <SubstanceName>GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>388; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210401</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies: 1 helps loosen phlegm (mucus), 2 loosens nasal congestion, 3 thin bronchial secretions, 4 drain bronchial tubes, 5 make coughs more productive, 6 clears stuffy nose, 7 clear nasal passageways, 8 shrinks swollen membranes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67296-0332-1</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (67296-0332-1) </PackageDescription>
    <NDC11Code>67296-0332-01</NDC11Code>
    <ProductNDC>67296-0332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Penicillin V Potassium</ProprietaryName>
    <NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062935</ApplicationNumber>
    <LabelerName>RedPharm Drug, Inc.</LabelerName>
    <SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. [Penicillin V Potassium Chemical Structure]. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&amp;C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>69452-332-20</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (69452-332-20) </PackageDescription>
    <NDC11Code>69452-0332-20</NDC11Code>
    <ProductNDC>69452-332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Terazosin</ProprietaryName>
    <NonProprietaryName>Terazosin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240311</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075667</ApplicationNumber>
    <LabelerName>Bionpharma Inc.</LabelerName>
    <SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240311</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&amp;C yellow no. 10 (2 mg, 5 mg and 10 mg), D&amp;C red no. 28 (5 mg), FD&amp; C green no. 3 (10 mg), FD&amp;C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-332-20</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (71205-332-20) </PackageDescription>
    <NDC11Code>71205-0332-20</NDC11Code>
    <ProductNDC>71205-332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150331</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040604</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27CIN2O2·2HCl. M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, D&amp;C Yellow #10 Aluminum Lake (25 mg and 50 mg), FD&amp;C Blue #2 Aluminum Lake (25 mg), FD&amp;C Red #40 Aluminum Lake (50 mg), FD&amp;C Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0332-5</NDCCode>
    <PackageDescription>20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-5) </PackageDescription>
    <NDC11Code>71335-0332-05</NDC11Code>
    <ProductNDC>71335-0332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075576</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&amp;C Yellow No. 10 aluminum lake, FD&amp;C Blue No. 1 aluminum lake, FD&amp;C Blue No. 2 aluminum lake, FD&amp;C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>77282-332-20</NDCCode>
    <PackageDescription>591 mL in 1 BOTTLE (77282-332-20) </PackageDescription>
    <NDC11Code>77282-0332-20</NDC11Code>
    <ProductNDC>77282-332</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Sustainable Tech LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0409-0007-10</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0409-0007-10)  / 20 mL in 1 VIAL, MULTI-DOSE (0409-0007-01) </PackageDescription>
    <NDC11Code>00409-0007-10</NDC11Code>
    <ProductNDC>0409-0007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20241028</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089644</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
    <StrengthNumber>10; 10</StrengthNumber>
    <StrengthUnit>mg/mL; ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
    <Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-0021-03</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>0409-0125-25</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25)  / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01) </PackageDescription>
    <NDC11Code>00409-0125-25</NDC11Code>
    <ProductNDC>0409-0125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075240</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230807</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.</IndicationAndUsage>
    <Description>Labetalol hydrochloride is an adrenergic receptor blocking agent that has both selective alpha1- and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate, chemically designated as 5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl]-salicylamide monohydrochloride, and has the following structural formula. Labetalol hydrochloride has the molecular formula C19H24N2O3  HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-0147-10</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0409-0147-10)  / 20 mL in 1 VIAL, MULTI-DOSE (0409-0147-01) </PackageDescription>
    <NDC11Code>00409-0147-10</NDC11Code>
    <ProductNDC>0409-0147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20241028</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089646</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
    <StrengthNumber>20; 10</StrengthNumber>
    <StrengthUnit>mg/mL; ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
    <Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-0201-20</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-0201-20)  / 16 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00409-0201-20</NDC11Code>
    <ProductNDC>0409-0201</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Docetaxel</ProprietaryName>
    <NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20110317</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022234</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
    <Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous), and multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-0212-02</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0212-02)  / 20 mL in 1 VIAL, SINGLE-DOSE (0409-0212-11) </PackageDescription>
    <NDC11Code>00409-0212-02</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>20150401</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>0409-0323-20</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0323-20)  &gt; 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00409-0323-20</NDC11Code>
    <ProductNDC>0409-0323</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bleomycin</ProprietaryName>
    <NonProprietaryName>Bleomycin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20180425</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065031</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>BLEOMYCIN SULFATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[USP'U]/1</StrengthUnit>
    <Pharm_Classes>Cytoprotective Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180425</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents. Squamous Cell Carcinoma. Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to bleomycin is poorer in patients with previously irradiated head and neck cancer. Lymphomas. Hodgkin's disease, non-Hodgkin's lymphoma. Testicular Carcinoma. Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin has also been shown to be useful in the management of:. Malignant Pleural Effusion Bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.</IndicationAndUsage>
    <Description>Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. It is freely soluble in water. It is available as a lyophilized powder for intramuscular, intravenous or subcutaneous injection. Each vial contains sterile bleomycin sulphate equivalent to 15 units or 30 units of bleomycin. Sulfuric acid or Sodium hydroxide used, if necessary to adjust the pH. Bleomycins are a group of related basic glycopeptides which differ in the terminal amine substituent of the common structural unit, bleomycin acid. The main components of Bleomycin for Injection are bleomycins A2 and B2. Chemically, bleomycin A2 is N1-[3-(dimethylsulfonio)propyl]-bleomycinamide and bleomycin B2 is N1-[4-(aminoiminomethyl)amino]butyl]-bleomycinamide. The molecular formula of bleomycin A2 is C55H84N17O21S3 and a calculated molecular weight of 1414. The molecular formula of bleomycin B2 is C55H84N20O21S2 and a calculated molecular weight of 1425. The structural formula of bleomycins A2 and B2 are shown below. Note: A unit of bleomycin is equal to the formerly used milligram activity. The term milligram activity is a misnomer and was changed to units to be more precise.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-0501-98</NDCCode>
    <PackageDescription>20 VIAL, SINGLE-DOSE in 1 TRAY (0409-0501-98)  / 50 mL in 1 VIAL, SINGLE-DOSE (0409-0501-97) </PackageDescription>
    <NDC11Code>00409-0501-98</NDC11Code>
    <ProductNDC>0409-0501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propofol</ProprietaryName>
    <NonProprietaryName>Propofol</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077908</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>PROPOFOL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
    <Description>Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white to slight off-white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.28. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of egg lecithin (12 mg/mL), 1.5 mg of benzyl alcohol (1.5 mg/mL), 0.7 mg of sodium benzoate (0.7 mg/mL), and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-1005-20</NDCCode>
    <PackageDescription>20 POUCH in 1 CASE (0409-1005-20)  / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0409-1005-01) </PackageDescription>
    <NDC11Code>00409-1005-20</NDC11Code>
    <ProductNDC>0409-1005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Heparin Sodium</ProprietaryName>
    <NonProprietaryName>Heparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230227</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018916</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>HEPARIN SODIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>[USP'U]/100mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.</IndicationAndUsage>
    <Description>Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. Each 100 mL contains heparin sodium 200 USP Units; sodium chloride, 0.9 g; citric acid, monohydrate, 40 mg and dibasic sodium phosphate, heptahydrate, 434 mg added as buffers. Each liter contains the following electrolytes: Sodium 186.4 mEq; phosphate (as HPO4=) 32.4 mEq, citrate 5.7 mEq and chloride 154 mEq. Osmolar concentration, 378 mOsmol/liter (calc.); pH 7.0 (5.0 – 7.5). Heparin Sodium, USP is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose-6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) &gt; (1) &gt; (4) &gt; (3) &gt; (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. Dibasic Sodium Phosphate, USP (heptahydrate), is chemically designated (Na2HPO4 ∙ 7H2O), colorless or white granular salt freely soluble in water. Citric Acid, USP, hydrous (monohydrate) is chemically designated C6H8O7 ∙ H2O, colorless, translucent crystals or white crystalline powder very soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from either polyvinylchloride or polyolefin plastic. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-1029-02</NDCCode>
    <PackageDescription>20 BAG in 1 CARTON (0409-1029-02)  &gt; 500 mL in 1 BAG (0409-1029-11) </PackageDescription>
    <NDC11Code>00409-1029-02</NDC11Code>
    <ProductNDC>0409-1029</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voluven</ProprietaryName>
    <NonProprietaryName>Hydroxyethyl Starch 130/0.4</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100625</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN070012</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>HYDROXYETHYL STARCH 130/0.4</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0409-1061-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1061-01)  / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00409-1061-01</NDC11Code>
    <ProductNDC>0409-1061</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pemetrexed</ProprietaryName>
    <NonProprietaryName>Pemetrexed</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220620</StartMarketingDate>
    <EndMarketingDate>20250831</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208746</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>PEMETREXED TROMETHAMINE ANHYDROUS</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20220620</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pemetrexed for 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 for 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 ditromethamine, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl]benzoyl]-, ditromethamine dihydrate with a molecular formula of C28H47N7O14 and a molecular weight of 705.68. The structural formula is as follows. Pemetrexed for Injection is a sterile white-to-light yellow or green-yellow lyophilized powder in single-dose vials to be reconstituted for intravenous infusion. Each 100-mg vial of Pemetrexed for Injection contains 100 mg pemetrexed (equivalent to 157 mg pemetrexed ditromethamine) and 106 mg mannitol. Each 500-mg vial of Pemetrexed for Injection contains 500 mg pemetrexed (equivalent to 783 mg pemetrexed ditromethamine) and 500 mg mannitol. Each 1-gram vial of Pemetrexed for Injection contains 1 gram pemetrexed (equivalent to 1.57 gram pemetrexed ditromethamine) and 1 gram mannitol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-1067-20</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1067-20)  &gt; 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00409-1067-20</NDC11Code>
    <ProductNDC>0409-1067</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbocaine</ProprietaryName>
    <NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION</RouteName>
    <StartMarketingDate>20070131</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA012250</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0409-1103-01</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1103-01)  / 20 mL in 1 VIAL, SINGLE-DOSE (0409-1103-11) </PackageDescription>
    <NDC11Code>00409-1103-01</NDC11Code>
    <ProductNDC>0409-1103</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cisatracurium Besylate</ProprietaryName>
    <NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20191202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203236</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cisatracurium Besylate Injection is indicated: 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU, 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older.</IndicationAndUsage>
    <Description>Cisatracurium besylate is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.5. The structural formula of cisatracurium besylate is. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution provided in 5 mL, 10 mL, and 20 mL vials. The pH is adjusted to 3.0 to 3.8 with benzenesulfonic acid. : 1 The 5 mL single-dose vials contain 2 mg/mL cisatracurium, equivalent to 2.68 mg/mL cisatracurium besylate., 2 The 10 mL multiple-dose vials contain 2 mg/mL cisatracurium, equivalent to 2.68 mg/mL cisatracurium besylate, and 0.9% benzyl alcohol as a preservative., 3 The 20 mL single-dose vials contain 10 mg/mL cisatracurium, equivalent to 13.38 mg/mL cisatracurium besylate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-1134-03</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1134-03)  &gt; 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>0409-1201-20</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-1201-20)  &gt; 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00409-1201-20</NDC11Code>
    <ProductNDC>0409-1201</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Demerol</ProprietaryName>
    <NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20060315</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021171</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2021-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0409-1391-22</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (0409-1391-22)  / 20 mL in 1 VIAL (0409-1391-21) </PackageDescription>
    <NDC11Code>00409-1391-22</NDC11Code>
    <ProductNDC>0409-1391</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20191009</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091404</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191009</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 1 4.Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1), 2 5.Complicated intra-abdominal infections (adult and pediatric patients). (1.2), 3 6.Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3).</IndicationAndUsage>
    <Description>Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [see Dosage and Administration (2.4)].</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-1454-20</NDCCode>
    <PackageDescription>20 BOTTLE in 1 TRAY (0409-1454-20)  / 50 mL in 1 BOTTLE (0409-1454-01) </PackageDescription>
    <NDC11Code>00409-1454-20</NDC11Code>
    <ProductNDC>0409-1454</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Precedex</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220307</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021038</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>PRECEDEX (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection (4 mcg/mL) is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. PRECEDEX contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine Dexmedetomidine hydrochloride chemical name is 1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride, (S). Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 ∙ HCl and the structural formula is. PRECEDEX in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-1511-98</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1511-98)  / 20 mL in 1 VIAL, SINGLE-DOSE (0409-1511-97) </PackageDescription>
    <NDC11Code>00409-1511-98</NDC11Code>
    <ProductNDC>0409-1511</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propofol</ProprietaryName>
    <NonProprietaryName>Propofol</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077908</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>PROPOFOL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
    <Description>Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white to slight off-white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.28. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of egg lecithin (12 mg/mL), 1.5 mg of benzyl alcohol (1.5 mg/mL), 0.7 mg of sodium benzoate (0.7 mg/mL), and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-1634-01</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (0409-1634-01)  &gt; 20 mL in 1 VIAL (0409-1634-85) </PackageDescription>
    <NDC11Code>00409-1634-01</NDC11Code>
    <ProductNDC>0409-1634</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vecuronium Bromide</ProprietaryName>
    <NonProprietaryName>Vecuronium Bromide</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20060303</StartMarketingDate>
    <EndMarketingDate>20230501</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075164</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>VECURONIUM BROMIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20060303</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230501</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
    <Description>Vecuronium bromide for injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as 1-(3α,17β-Dihydroxy-2β-piperidino-5α-androstan-16β,5α-yl)-1-methylpiperidinium bromide, diacetate. Vecuronium bromide for injection is prepared as a solution and lyophilized in its final container. The structural formula is. Its chemical formula is C34H57BrN2O4 with molecular weight 637.73. Vecuronium bromide is supplied as a sterile nonpyrogenic freeze-dried buffered cake of very fine microscopic crystalline particles for intravenous injection only. Each 10 mL vial contains 10 mg vecuronium bromide, 20.75 mg citric acid anhydrous, 16.25 mg sodium phosphate dibasic anhydrous, 97 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH of 4 (3.5 to 4.5). Each 20 mL vial contains 20 mg of vecuronium bromide, 41.5 mg citric acid anhydrous, 32.5 mg sodium phosphate dibasic anhydrous, 194 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH of 4 (3.5 to 4.5). Bacteriostatic water for injection, USP when used contains BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-1634-49</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (0409-1634-49)  &gt; 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00409-1634-49</NDC11Code>
    <ProductNDC>0409-1634</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vecuronium Bromide</ProprietaryName>
    <NonProprietaryName>Vecuronium Bromide</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19991021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075164</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>VECURONIUM BROMIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0409-1660-20</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (0409-1660-20)  / 20 mL in 1 VIAL (0409-1660-22) </PackageDescription>
    <NDC11Code>00409-1660-20</NDC11Code>
    <ProductNDC>0409-1660</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Precedex</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130408</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021038</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PRECEDEX is a alpha2-adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer PRECEDEX by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2), 3 Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. (1.2).</IndicationAndUsage>
    <Description>PRECEDEX (dexmedetomidine hydrochloride) injection (100 mcg/mL) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. PRECEDEX (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection (4 mcg/mL) is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. PRECEDEX contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is 1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride, (S). Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. PRECEDEX Injection is intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. PRECEDEX in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-1660-50</NDCCode>
    <PackageDescription>20 BOTTLE in 1 TRAY (0409-1660-50)  / 50 mL in 1 BOTTLE (0409-1660-55) </PackageDescription>
    <NDC11Code>00409-1660-50</NDC11Code>
    <ProductNDC>0409-1660</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Precedex</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130408</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021038</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130408</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PRECEDEX is a alpha2-adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer PRECEDEX by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2), 3 Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. (1.2).</IndicationAndUsage>
    <Description>PRECEDEX (dexmedetomidine hydrochloride) injection (100 mcg/mL) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. PRECEDEX (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection (4 mcg/mL) is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. PRECEDEX contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is 1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride, (S). Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. PRECEDEX Injection is intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. PRECEDEX in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
  </NDC>
</NDCList>