RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>70121-1743-4</NDCCode>
    <PackageDescription>6 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4)  / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>70121-1743-04</NDC11Code>
    <ProductNDC>70121-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nelarabine</ProprietaryName>
    <NonProprietaryName>Nelarabine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216346</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>NELARABINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.</IndicationAndUsage>
    <Description>Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β-D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β-D-arabinofuranosyl-6-methoxy-9H-purine. It has the molecular formula C11H15N5O5 and a molecular weight of 297.27 g/mol. Nelarabine has the following structural formula. Nelarabine is a white to off-white solid. It is soluble in dimethylformamide, slightly soluble in water, and practically insoluble in acetone. It melts with decomposition between 209°C and 214°C. Nelarabine Injection, 250 mg/50 mL (5 mg/mL) is available as a sterile, clear, colorless solution filled in clear glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in 50 mL Water for Injection, USP. Nelarabine injection is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>70121-1743-1</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-1)  / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>70121-1743-01</NDC11Code>
    <ProductNDC>70121-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nelarabine</ProprietaryName>
    <NonProprietaryName>Nelarabine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216346</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>NELARABINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.</IndicationAndUsage>
    <Description>Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β-D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β-D-arabinofuranosyl-6-methoxy-9H-purine. It has the molecular formula C11H15N5O5 and a molecular weight of 297.27 g/mol. Nelarabine has the following structural formula. Nelarabine is a white to off-white solid. It is soluble in dimethylformamide, slightly soluble in water, and practically insoluble in acetone. It melts with decomposition between 209°C and 214°C. Nelarabine Injection, 250 mg/50 mL (5 mg/mL) is available as a sterile, clear, colorless solution filled in clear glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in 50 mL Water for Injection, USP. Nelarabine injection is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-1743-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1743-4)</PackageDescription>
    <NDC11Code>36987-1743-04</NDC11Code>
    <ProductNDC>36987-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spearmint</ProprietaryName>
    <NonProprietaryName>Spearmint</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>SPEARMINT</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [CS],Allergens [CS],Dietary Proteins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-1743-4</NDCCode>
    <PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-1743-4) </PackageDescription>
    <NDC11Code>37662-1743-04</NDC11Code>
    <ProductNDC>37662-1743</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ledum Palustre</ProprietaryName>
    <NonProprietaryName>Ledum Palustre</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221019</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>RHODODENDRON TOMENTOSUM LEAFY TWIG</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-10-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221019</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>54868-1743-4</NDCCode>
    <PackageDescription>90 TABLET in 1 DOSE PACK (54868-1743-4)</PackageDescription>
    <NDC11Code>54868-1743-04</NDC11Code>
    <ProductNDC>54868-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA083365</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Endocrine Disorders  Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)   Congenital adrenal hyperplasia   Nonsuppurative thyroiditis   Hypercalcemia associated with cancer . Rheumatic Disorders  As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:   Psoriatic arthritis   Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy):   Ankylosing spondylitis   Acute and subacute bursitis   Acute nonspecific tenosynovitis   Acute gouty arthritis   Post-traumatic osteoarthritis   Synovitis or osteoarthritis   Epicondylitis . Collagen Diseases  During an exacerbation or as maintenance therapy in selected cases of:   Systemic lupus erythematosus   Acute rheumatic carditis   Systemic dermatomyositis (polymyositis) . Dermatologic Diseases  Pemphigus   Bullous dermatitis herpetiformis   Severe erythema multiforme (Stevens-Johnson syndrome)   Exfoliative dermatitis   Mycosis fungoides   Severe psoriasis   Severe seborrheic dermatitis . Allergic States  Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:   Seasonal or perennial allergic rhinitis   Bronchial asthma   Contact dermatitis   Atopic dermatitis   Serum sickness   Drug hypersensitivity reactions . Ophthalmic Diseases  Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:   Allergic conjunctivitis   Keratitis   Allergic corneal marginal ulcers   Herpes zoster ophthalmicus   Iritis and iridocyclitis   Chorioretinitis   Anterior segment inflammation   Diffuse posterior uveitis and choroiditis   Optic neuritis   Sympathetic ophthalmia . Respiratory Disease  Symptomatic sarcoidosis   Loeffler's syndrome not manageable by other means   Berylliosis   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy   Aspiration pneumonitis . Hematologic Disorder  Idiopathic thrombocytopenic purpura in adults   Secondary thrombocytopenia in adults   Acquired (autoimmune) hemolytic anemia   Erythroblastopenia (RBC anemia)   Congenital (erythroid) hypoplastic anemia . Neoplastic Disease  For palliative management of:   Leukemias and lymphomas in adults   Acute leukemia of childhood . Edematous States  To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus . Gastrointestinal Diseases  To tide the patient over a critical period of the disease in:   Ulcerative colitis   Regional enteritis . Miscellaneous  Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy   Trichinosis with neurologic or myocardial involvement .</IndicationAndUsage>
    <Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. The molecular weight is 362.47. It is designated chemically as 11B, 17,21-trihydroxy-pregn-4-ene-3,20-dione. The molecular formula is C21H30O5 and the structural formula is. Hydrocortisone is believed to be the principal hormone secreted by the adrenal cortex. Each tablet for oral administration contains 20 mg of hydrocortisone. Inactive Ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>64942-1743-4</NDCCode>
    <PackageDescription>946 mL in 1 BOTTLE (64942-1743-4) </PackageDescription>
    <NDC11Code>64942-1743-04</NDC11Code>
    <ProductNDC>64942-1743</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200522</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Conopco, Inc. d/b/a/ Unilever</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>72</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use(s) Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71335-1743-4</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (71335-1743-4) </PackageDescription>
    <NDC11Code>71335-1743-04</NDC11Code>
    <ProductNDC>71335-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191212</StartMarketingDate>
    <EndMarketingDate>20240930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073556</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240906</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70121-1164-1</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (70121-1164-1)  &gt; 4 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>70121-1164-01</NDC11Code>
    <ProductNDC>70121-1164</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20160725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207552</ApplicationNumber>
    <LabelerName>Amneal Biosciences</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/4mL</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-24</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>70121-1164-5</NDCCode>
    <PackageDescription>25 VIAL, GLASS in 1 CARTON (70121-1164-5)  / 4 mL in 1 VIAL, GLASS (70121-1164-1) </PackageDescription>
    <NDC11Code>70121-1164-05</NDC11Code>
    <ProductNDC>70121-1164</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20160725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207552</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/4mL</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.</IndicationAndUsage>
    <Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellow, odorless, crystalline powder. It is practically insoluble in water; freely soluble in acetone, in dimethylformamide and in solutions of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; slightly soluble in ether; very slightly soluble in chloroform. The structural formula is as follows. Each mL contains: Furosemide, USP 10 mg, Sodium Hydroxide 1.3 mg, Water for Injection q.s., Sodium Chloride for isotonicity, additional Sodium Hydroxide (q.s.) and, if necessary, Hydrochloric Acid (q.s.) to adjust pH between 8.0 and 9.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>70121-1222-1</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (70121-1222-1)  / 4 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>70121-1222-01</NDC11Code>
    <ProductNDC>70121-1222</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Docetaxel</ProprietaryName>
    <NonProprietaryName>Docetaxel</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209640</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/4mL</StrengthUnit>
    <Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180119</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 anhydrous is benzenepropanoic acid, β-[[(1,1-dimethylethoxy) carbonyl) amino]-α-hydroxy-, 12b- (acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl ester. Docetaxel anhydrous has the following structural formula. Docetaxel anhydrous, USP is a white or almost white crystalline powder with an molecular formula of C43H53NO14, and a molecular weight of 807.88. It is practically insoluble in water, soluble in acetone and methanol. One-vial Docetaxel Injection, USP. Docetaxel Injection, USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel anhydrous USP, 0.4 mg citric acid anhydrous in 0.54 g polysorbate 80 and 0.395 g dehydrated alcohol (50% v/v) solution. Docetaxel Injection, USP is available in single-dose vials containing 20 mg (1 mL), 80 mg (4 mL) and 160 mg (8 mL) docetaxel anhydrous, USP. Docetaxel Injection, USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>70121-1576-7</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (70121-1576-7)  / 4 mL in 1 VIAL (70121-1576-1) </PackageDescription>
    <NDC11Code>70121-1576-07</NDC11Code>
    <ProductNDC>70121-1576</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norepinephrine Bitartrate</ProprietaryName>
    <NonProprietaryName>Norepinephrine Bitartrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210839</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>NOREPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). As an adjunct in the treatment of cardiac arrest and profound hypotension.</IndicationAndUsage>
    <Description>Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate and has the following structural formula. Norepinephrine bitartrate, USP is a white to faintly grey powder with a molecular formula of C8H11NO3C4H6O6H2O, and a molecular weight of 337.28 g/mol. It is freely soluble in water, slightly soluble in alcohol, practically insoluble in chloroform and in ether. Norepinephrine bitartrate injection, USP is a clear, colorless or practically colorless to slightly yellow color liquid and supplied in sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion following dilution.  Each mL contains the equivalent of 1 mg base of norepinephrine, sodium chloride for isotonicity, and not more than 0.2 mg of sodium metabisulfite as an antioxidant. It has a pH of 3 to 4.5. The air in the vials has been displaced by nitrogen gas.</Description>
  </NDC>
  <NDC>
    <NDCCode>70121-1584-4</NDCCode>
    <PackageDescription>4 VIAL in 1 CARTON (70121-1584-4)  / 20 mL in 1 VIAL (70121-1584-1) </PackageDescription>
    <NDC11Code>70121-1584-04</NDC11Code>
    <ProductNDC>70121-1584</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
    <NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211374</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70121-1586-3</NDCCode>
    <PackageDescription>5 VIAL in 1 CARTON (70121-1586-3)  / 4 mL in 1 VIAL (70121-1586-1) </PackageDescription>
    <NDC11Code>70121-1586-03</NDC11Code>
    <ProductNDC>70121-1586</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180717</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210994</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180717</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Verapamil hydrochloride injection is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration., 2 Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).</IndicationAndUsage>
    <Description>Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil hydrochloride injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride USP, 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid for pH adjustment; pH is 4.9 (4.0 to 6.5). The chemical name of verapamil hydrochloride is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride (±)-. Verapamil hydrochloride, USP is white or practically white crystalline powder. It is practically odorless and has a bitter taste with a molecular formula C27H38N2O4HCl, and a molecular weight of 491.06 g/mol. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.</Description>
  </NDC>
  <NDC>
    <NDCCode>70121-1686-1</NDCCode>
    <PackageDescription>1 CARTRIDGE in 1 CARTON (70121-1686-1)  / 2.4 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>70121-1686-01</NDC11Code>
    <ProductNDC>70121-1686</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Exenatide</ProprietaryName>
    <NonProprietaryName>Exenatide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20241122</StartMarketingDate>
    <EndMarketingDate>20270531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206697</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>EXENATIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20241122</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Exenatide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Exenatide is a synthetic peptide, GLP-1 receptor agonist, that was originally identified in the lizard Heloderma suspectum. Exenatide is a 39-amino acid peptide amide. Exenatide has the empirical formula C184H282N50O60S and molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below. H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2. Exenatide injection, USP is supplied for subcutaneous administration as a sterile, preserved isotonic solution in a glass cartridge that has been assembled in a pen-injector (pen). Each milliliter (mL) contains 250 micrograms (mcg) synthetic exenatide, USP; 2.2 mg metacresol as an antimicrobial preservative; mannitol as a tonicity-adjusting agent; and glacial acetic acid and sodium acetate trihydrate in water for injection as a buffering solution at pH 4.5. Two prefilled pens are available to deliver unit doses of 5 mcg per dose or 10 mcg per dose. Each prefilled pen will deliver 60 doses to provide for 30 days of twice daily administration (BID). Each prefilled device is filled with volume to allow delivery of 1.2 mL or 2.4 mL. Each device contains additional volume to allow for troubleshooting the device 4 times.</Description>
  </NDC>
  <NDC>
    <NDCCode>70121-1706-4</NDCCode>
    <PackageDescription>24 CARTON in 1 PACKAGE (70121-1706-4)  / 1 SYRINGE, GLASS in 1 CARTON (70121-1706-1)  / 10 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>70121-1706-04</NDC11Code>
    <ProductNDC>70121-1706</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropine Sulfate</ProprietaryName>
    <NonProprietaryName>Atropine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215342</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ATROPINE SULFATE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning and to treat bradyasystolic cardiac arrest.</IndicationAndUsage>
    <Description>Atropine sulfate injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg (adult strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 6.5. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine sulfate, USP is chemically designated 1α H, 5α H-tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 H2SO4 H2O, colorless, almost white to white solid. It is very soluble in water and glacial acetic acid, freely soluble in ethanol (96%) and practically insoluble in diethyl ether. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>70121-1754-1</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (70121-1754-1)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>70121-1754-01</NDC11Code>
    <ProductNDC>70121-1754</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alymsys</ProprietaryName>
    <NonProprietaryName>Bevacizumab-maly</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220415</StartMarketingDate>
    <EndMarketingDate>20281031</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761231</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BEVACIZUMAB</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/4mL</StrengthUnit>
    <Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20220415</StartMarketingDatePackage>
    <EndMarketingDatePackage>20281031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alymsys is a vascular endothelial growth factor inhibitor indicated for the treatment of: : 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1) , 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) .</IndicationAndUsage>
    <Description>Bevacizumab-maly is a vascular endothelial growth factor inhibitor. Bevacizumab-maly is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-maly has an approximate molecular weight of 149 kDa. Bevacizumab-maly is produced in a mammalian cell (Chinese Hamster Ovary) expression system.  Alymsys (bevacizumab-maly) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial for intravenous use. Alymsys contains bevacizumab-maly at a concentration of 25 mg/mL in either a 100 mg/4 mL or 400 mg/16 mL single-dose vial. Each mL of solution contains 25 mg bevacizumab-maly, α,α-trehalose dihydrate (60 mg), polysorbate 20 (0.4 mg), sodium phosphate dibasic, anhydrous (1.2 mg), sodium phosphate monobasic, monohydrate (5.8 mg), and Water for Injection, USP. The pH is 6.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>70121-1754-7</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (70121-1754-7)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>70121-1754-07</NDC11Code>
    <ProductNDC>70121-1754</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alymsys</ProprietaryName>
    <NonProprietaryName>Bevacizumab-maly</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220415</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761231</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BEVACIZUMAB</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/4mL</StrengthUnit>
    <Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alymsys is a vascular endothelial growth factor inhibitor indicated for the treatment of: : 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1) , 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) .</IndicationAndUsage>
    <Description>Bevacizumab-maly is a vascular endothelial growth factor inhibitor. Bevacizumab-maly is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-maly has an approximate molecular weight of 149 kDa. Bevacizumab-maly is produced in a mammalian cell (Chinese Hamster Ovary) expression system.  Alymsys (bevacizumab-maly) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial for intravenous use. Alymsys contains bevacizumab-maly at a concentration of 25 mg/mL in either a 100 mg/4 mL or 400 mg/16 mL single-dose vial. Each mL of solution contains 25 mg bevacizumab-maly, α,α-trehalose dihydrate (60 mg), polysorbate 20 (0.4 mg), sodium phosphate dibasic, anhydrous (1.2 mg), sodium phosphate monobasic, monohydrate (5.8 mg), and Water for Injection, USP. The pH is 6.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>70121-2308-4</NDCCode>
    <PackageDescription>24 CARTON in 1 CARTON (70121-2308-4)  / 1 SYRINGE, GLASS in 1 CARTON (70121-2308-1)  / 10 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>70121-2308-04</NDC11Code>
    <ProductNDC>70121-2308</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Chloride</ProprietaryName>
    <NonProprietaryName>Calcium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240717</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217524</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>CALCIUM CHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240717</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium chloride injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use. The safety and effectiveness of calcium chloride injection for long-term use has not been established.</IndicationAndUsage>
    <Description>10% Calcium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic, clear, colorless solution for single administration only. Each mL contains 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca++ and Cl−) in water for injection. It is provided in a 10 mL single-dose syringe and 10 mL single-dose vial for intravenous injection. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH of 10% calcium chloride injection, USP is between 5.5 to 7.5 when diluted with water for injection to make a 5% solution. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10% calcium chloride injection, USP is oxygen sensitive. Calcium chloride dihydrate, USP is chemically designated CaCl2  2H2O (dihydrate) and its structural formula is as below. It appears as white, hard, odorless fragments or granules. It is deliquescent. It is very soluble in boiling water, freely soluble in water, in alcohol and in boiling alcohol. Calcium chloride injection, USP contains no more than 1,000 mcg/L of aluminum [see Warnings and Precautions (5.2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>70121-2428-3</NDCCode>
    <PackageDescription>24 CARTON in 1 CARTON (70121-2428-3)  / 1 SYRINGE, GLASS in 1 CARTON (70121-2428-1)  / 4 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>70121-2428-03</NDC11Code>
    <ProductNDC>70121-2428</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251002</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218870</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</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>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251002</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol hydrochloride 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 hydrochloride 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 g/mol. 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, USP is a white to off-white powder, sparingly soluble in water and in ethanol (96%), practically insoluble in methylene chloride. Labetalol hydrochloride injection, USP 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>70121-2484-1</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (70121-2484-1)  / 1.4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>70121-2484-01</NDC11Code>
    <ProductNDC>70121-2484</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Boruzu</ProprietaryName>
    <NonProprietaryName>Bortezomib</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20240927</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212782</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BORTEZOMIB</SubstanceName>
    <StrengthNumber>3.5</StrengthNumber>
    <StrengthUnit>mg/1.4mL</StrengthUnit>
    <Pharm_Classes>Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240927</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BORUZU is a proteasome inhibitor indicated for: : 1 treatment of adult patients with multiple myeloma (1.1), 2 treatment of adult patients with mantle cell lymphoma (1.2).</IndicationAndUsage>
    <Description>Bortezomib, a proteasome inhibitor, is an antineoplastic agent available for intravenous or subcutaneous injection. The chemical name for bortezomib {(1R)-3-Methyl-1-[(2S)-3-phenyl-2-(pyrazin-2-carboxamido)propanamido]butyl}boronic acid. The structural formula is as follows. The molecular formula of bortezomib is C19H25BN4O4; it has a molecular weight of 384.24. Bortezomib is freely soluble in methanol, ethanol and dimethyl sulfoxide, practically insoluble in toluene, pH range of 4 to 6.5. BORUZU is available as a single-dose vial containing 3.5 mg of bortezomib as a sterile solution. Each 1 mL of solution contains 2.5 mg bortezomib, 25 mg mannitol, sodium chloride for isotonicity and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-1743-0</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (54868-1743-0)</PackageDescription>
    <NDC11Code>54868-1743-00</NDC11Code>
    <ProductNDC>54868-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA083365</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Endocrine Disorders  Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)   Congenital adrenal hyperplasia   Nonsuppurative thyroiditis   Hypercalcemia associated with cancer . Rheumatic Disorders  As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:   Psoriatic arthritis   Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy):   Ankylosing spondylitis   Acute and subacute bursitis   Acute nonspecific tenosynovitis   Acute gouty arthritis   Post-traumatic osteoarthritis   Synovitis or osteoarthritis   Epicondylitis . Collagen Diseases  During an exacerbation or as maintenance therapy in selected cases of:   Systemic lupus erythematosus   Acute rheumatic carditis   Systemic dermatomyositis (polymyositis) . Dermatologic Diseases  Pemphigus   Bullous dermatitis herpetiformis   Severe erythema multiforme (Stevens-Johnson syndrome)   Exfoliative dermatitis   Mycosis fungoides   Severe psoriasis   Severe seborrheic dermatitis . Allergic States  Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:   Seasonal or perennial allergic rhinitis   Bronchial asthma   Contact dermatitis   Atopic dermatitis   Serum sickness   Drug hypersensitivity reactions . Ophthalmic Diseases  Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:   Allergic conjunctivitis   Keratitis   Allergic corneal marginal ulcers   Herpes zoster ophthalmicus   Iritis and iridocyclitis   Chorioretinitis   Anterior segment inflammation   Diffuse posterior uveitis and choroiditis   Optic neuritis   Sympathetic ophthalmia . Respiratory Disease  Symptomatic sarcoidosis   Loeffler's syndrome not manageable by other means   Berylliosis   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy   Aspiration pneumonitis . Hematologic Disorder  Idiopathic thrombocytopenic purpura in adults   Secondary thrombocytopenia in adults   Acquired (autoimmune) hemolytic anemia   Erythroblastopenia (RBC anemia)   Congenital (erythroid) hypoplastic anemia . Neoplastic Disease  For palliative management of:   Leukemias and lymphomas in adults   Acute leukemia of childhood . Edematous States  To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus . Gastrointestinal Diseases  To tide the patient over a critical period of the disease in:   Ulcerative colitis   Regional enteritis . Miscellaneous  Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy   Trichinosis with neurologic or myocardial involvement .</IndicationAndUsage>
    <Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. The molecular weight is 362.47. It is designated chemically as 11B, 17,21-trihydroxy-pregn-4-ene-3,20-dione. The molecular formula is C21H30O5 and the structural formula is. Hydrocortisone is believed to be the principal hormone secreted by the adrenal cortex. Each tablet for oral administration contains 20 mg of hydrocortisone. Inactive Ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-1743-1</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (54868-1743-1)</PackageDescription>
    <NDC11Code>54868-1743-01</NDC11Code>
    <ProductNDC>54868-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA083365</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Endocrine Disorders  Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)   Congenital adrenal hyperplasia   Nonsuppurative thyroiditis   Hypercalcemia associated with cancer . Rheumatic Disorders  As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:   Psoriatic arthritis   Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy):   Ankylosing spondylitis   Acute and subacute bursitis   Acute nonspecific tenosynovitis   Acute gouty arthritis   Post-traumatic osteoarthritis   Synovitis or osteoarthritis   Epicondylitis . Collagen Diseases  During an exacerbation or as maintenance therapy in selected cases of:   Systemic lupus erythematosus   Acute rheumatic carditis   Systemic dermatomyositis (polymyositis) . Dermatologic Diseases  Pemphigus   Bullous dermatitis herpetiformis   Severe erythema multiforme (Stevens-Johnson syndrome)   Exfoliative dermatitis   Mycosis fungoides   Severe psoriasis   Severe seborrheic dermatitis . Allergic States  Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:   Seasonal or perennial allergic rhinitis   Bronchial asthma   Contact dermatitis   Atopic dermatitis   Serum sickness   Drug hypersensitivity reactions . Ophthalmic Diseases  Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:   Allergic conjunctivitis   Keratitis   Allergic corneal marginal ulcers   Herpes zoster ophthalmicus   Iritis and iridocyclitis   Chorioretinitis   Anterior segment inflammation   Diffuse posterior uveitis and choroiditis   Optic neuritis   Sympathetic ophthalmia . Respiratory Disease  Symptomatic sarcoidosis   Loeffler's syndrome not manageable by other means   Berylliosis   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy   Aspiration pneumonitis . Hematologic Disorder  Idiopathic thrombocytopenic purpura in adults   Secondary thrombocytopenia in adults   Acquired (autoimmune) hemolytic anemia   Erythroblastopenia (RBC anemia)   Congenital (erythroid) hypoplastic anemia . Neoplastic Disease  For palliative management of:   Leukemias and lymphomas in adults   Acute leukemia of childhood . Edematous States  To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus . Gastrointestinal Diseases  To tide the patient over a critical period of the disease in:   Ulcerative colitis   Regional enteritis . Miscellaneous  Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy   Trichinosis with neurologic or myocardial involvement .</IndicationAndUsage>
    <Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. The molecular weight is 362.47. It is designated chemically as 11B, 17,21-trihydroxy-pregn-4-ene-3,20-dione. The molecular formula is C21H30O5 and the structural formula is. Hydrocortisone is believed to be the principal hormone secreted by the adrenal cortex. Each tablet for oral administration contains 20 mg of hydrocortisone. Inactive Ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-1743-2</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (54868-1743-2)</PackageDescription>
    <NDC11Code>54868-1743-02</NDC11Code>
    <ProductNDC>54868-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA083365</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Endocrine Disorders  Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)   Congenital adrenal hyperplasia   Nonsuppurative thyroiditis   Hypercalcemia associated with cancer . Rheumatic Disorders  As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:   Psoriatic arthritis   Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy):   Ankylosing spondylitis   Acute and subacute bursitis   Acute nonspecific tenosynovitis   Acute gouty arthritis   Post-traumatic osteoarthritis   Synovitis or osteoarthritis   Epicondylitis . Collagen Diseases  During an exacerbation or as maintenance therapy in selected cases of:   Systemic lupus erythematosus   Acute rheumatic carditis   Systemic dermatomyositis (polymyositis) . Dermatologic Diseases  Pemphigus   Bullous dermatitis herpetiformis   Severe erythema multiforme (Stevens-Johnson syndrome)   Exfoliative dermatitis   Mycosis fungoides   Severe psoriasis   Severe seborrheic dermatitis . Allergic States  Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:   Seasonal or perennial allergic rhinitis   Bronchial asthma   Contact dermatitis   Atopic dermatitis   Serum sickness   Drug hypersensitivity reactions . Ophthalmic Diseases  Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:   Allergic conjunctivitis   Keratitis   Allergic corneal marginal ulcers   Herpes zoster ophthalmicus   Iritis and iridocyclitis   Chorioretinitis   Anterior segment inflammation   Diffuse posterior uveitis and choroiditis   Optic neuritis   Sympathetic ophthalmia . Respiratory Disease  Symptomatic sarcoidosis   Loeffler's syndrome not manageable by other means   Berylliosis   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy   Aspiration pneumonitis . Hematologic Disorder  Idiopathic thrombocytopenic purpura in adults   Secondary thrombocytopenia in adults   Acquired (autoimmune) hemolytic anemia   Erythroblastopenia (RBC anemia)   Congenital (erythroid) hypoplastic anemia . Neoplastic Disease  For palliative management of:   Leukemias and lymphomas in adults   Acute leukemia of childhood . Edematous States  To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus . Gastrointestinal Diseases  To tide the patient over a critical period of the disease in:   Ulcerative colitis   Regional enteritis . Miscellaneous  Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy   Trichinosis with neurologic or myocardial involvement .</IndicationAndUsage>
    <Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. The molecular weight is 362.47. It is designated chemically as 11B, 17,21-trihydroxy-pregn-4-ene-3,20-dione. The molecular formula is C21H30O5 and the structural formula is. Hydrocortisone is believed to be the principal hormone secreted by the adrenal cortex. Each tablet for oral administration contains 20 mg of hydrocortisone. Inactive Ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-1743-3</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (54868-1743-3)</PackageDescription>
    <NDC11Code>54868-1743-03</NDC11Code>
    <ProductNDC>54868-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA083365</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Endocrine Disorders  Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)   Congenital adrenal hyperplasia   Nonsuppurative thyroiditis   Hypercalcemia associated with cancer . Rheumatic Disorders  As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:   Psoriatic arthritis   Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy):   Ankylosing spondylitis   Acute and subacute bursitis   Acute nonspecific tenosynovitis   Acute gouty arthritis   Post-traumatic osteoarthritis   Synovitis or osteoarthritis   Epicondylitis . Collagen Diseases  During an exacerbation or as maintenance therapy in selected cases of:   Systemic lupus erythematosus   Acute rheumatic carditis   Systemic dermatomyositis (polymyositis) . Dermatologic Diseases  Pemphigus   Bullous dermatitis herpetiformis   Severe erythema multiforme (Stevens-Johnson syndrome)   Exfoliative dermatitis   Mycosis fungoides   Severe psoriasis   Severe seborrheic dermatitis . Allergic States  Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:   Seasonal or perennial allergic rhinitis   Bronchial asthma   Contact dermatitis   Atopic dermatitis   Serum sickness   Drug hypersensitivity reactions . Ophthalmic Diseases  Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:   Allergic conjunctivitis   Keratitis   Allergic corneal marginal ulcers   Herpes zoster ophthalmicus   Iritis and iridocyclitis   Chorioretinitis   Anterior segment inflammation   Diffuse posterior uveitis and choroiditis   Optic neuritis   Sympathetic ophthalmia . Respiratory Disease  Symptomatic sarcoidosis   Loeffler's syndrome not manageable by other means   Berylliosis   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy   Aspiration pneumonitis . Hematologic Disorder  Idiopathic thrombocytopenic purpura in adults   Secondary thrombocytopenia in adults   Acquired (autoimmune) hemolytic anemia   Erythroblastopenia (RBC anemia)   Congenital (erythroid) hypoplastic anemia . Neoplastic Disease  For palliative management of:   Leukemias and lymphomas in adults   Acute leukemia of childhood . Edematous States  To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus . Gastrointestinal Diseases  To tide the patient over a critical period of the disease in:   Ulcerative colitis   Regional enteritis . Miscellaneous  Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy   Trichinosis with neurologic or myocardial involvement .</IndicationAndUsage>
    <Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. The molecular weight is 362.47. It is designated chemically as 11B, 17,21-trihydroxy-pregn-4-ene-3,20-dione. The molecular formula is C21H30O5 and the structural formula is. Hydrocortisone is believed to be the principal hormone secreted by the adrenal cortex. Each tablet for oral administration contains 20 mg of hydrocortisone. Inactive Ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1743-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0115-1743-01) </PackageDescription>
    <NDC11Code>00115-1743-01</NDC11Code>
    <ProductNDC>0115-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glyburide</ProprietaryName>
    <NonProprietaryName>Glyburide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206079</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>GLYBURIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glyburide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glyburide Tablets, USP are an oral blood-glucose-lowering drug of the sulfonylurea class. It is a white, crystalline compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5 mg strengths for oral administration. Glyburide Tablets, USP contain the active ingredient glyburide and the following inactive ingredients: dibasic calcium phosphate anhydrous USP, dibasic calcium phosphate dihydrate USP, magnesium stearate NF, microcrystalline cellulose NF, sodium alginate NF, talc USP. Glyburide Tablets USP, 1.25 mg also contain FD&amp;C Yellow #6 Aluminum Lake. Glyburide Tablets USP, 2.5 mg also contain D&amp;C Red #27 Aluminum Lake. Glyburide Tablets USP, 5 mg also contain FD&amp;C Blue #1 Aluminum Lake. Chemically, glyburide is identified as 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea. The CAS Registry Number is 10238-21-8. The structural formula is. The molecular weight is 493.99. The aqueous solubility of glyburide increases with pH as a result of salt formation.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1743-03</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (0115-1743-03) </PackageDescription>
    <NDC11Code>00115-1743-03</NDC11Code>
    <ProductNDC>0115-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glyburide</ProprietaryName>
    <NonProprietaryName>Glyburide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206079</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>GLYBURIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glyburide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glyburide Tablets, USP are an oral blood-glucose-lowering drug of the sulfonylurea class. It is a white, crystalline compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5 mg strengths for oral administration. Glyburide Tablets, USP contain the active ingredient glyburide and the following inactive ingredients: dibasic calcium phosphate anhydrous USP, dibasic calcium phosphate dihydrate USP, magnesium stearate NF, microcrystalline cellulose NF, sodium alginate NF, talc USP. Glyburide Tablets USP, 1.25 mg also contain FD&amp;C Yellow #6 Aluminum Lake. Glyburide Tablets USP, 2.5 mg also contain D&amp;C Red #27 Aluminum Lake. Glyburide Tablets USP, 5 mg also contain FD&amp;C Blue #1 Aluminum Lake. Chemically, glyburide is identified as 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea. The CAS Registry Number is 10238-21-8. The structural formula is. The molecular weight is 493.99. The aqueous solubility of glyburide increases with pH as a result of salt formation.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-1743-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1743-01)</PackageDescription>
    <NDC11Code>00378-1743-01</NDC11Code>
    <ProductNDC>0378-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078183</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>212.6; 287.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-05-15</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0378-1743-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1743-05)</PackageDescription>
    <NDC11Code>00378-1743-05</NDC11Code>
    <ProductNDC>0378-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078183</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>212.6; 287.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-05-15</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0378-1743-89</NDCCode>
    <PackageDescription>50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1743-89) </PackageDescription>
    <NDC11Code>00378-1743-89</NDC11Code>
    <ProductNDC>0378-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070322</StartMarketingDate>
    <EndMarketingDate>20200131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078183</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN</SubstanceName>
    <StrengthNumber>287.5; 212.6</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-05-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20070322</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0527-1743-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0527-1743-01) </PackageDescription>
    <NDC11Code>00527-1743-01</NDC11Code>
    <ProductNDC>0527-1743</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110720</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201961</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine,  [seeClinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N  HCl    M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as oral capsules containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base).  Each phentermine hydrochloride capsule also contains the following inactive ingredients: lactose monohydrate, corn starch, hypromellose, and magnesium stearate. The light turquoise blue opaque/white opaque capsules contain gelatin, titanium dioxide, D&amp;C Red No. 28, FD&amp;C Blue No.1, and FD&amp;C Red No. 40. The capsule imprinting ink contains: shellac glaze in ethanol, iron oxide black, N-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, FD&amp;C Blue No.1 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake.</Description>
  </NDC>
</NDCList>