RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>70436-222-36</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (70436-222-36)  / 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>70436-0222-36</NDC11Code>
    <ProductNDC>70436-222</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin Dihydrate</ProprietaryName>
    <NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217036</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration ( 2)].</IndicationAndUsage>
    <Description>Azithromycin for Oral Suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>11084-076-36</NDCCode>
    <PackageDescription>222 mL in 1 BOTTLE, PLASTIC (11084-076-36)</PackageDescription>
    <NDC11Code>11084-0076-36</NDC11Code>
    <ProductNDC>11084-076</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Deb Gold</ProprietaryName>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Deb USA, Inc.</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.15</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses. For handwashing to reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-222-36</NDCCode>
    <PackageDescription>18 POUCH in 1 CARTON (41250-222-36)  / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
    <NDC11Code>41250-0222-36</NDC11Code>
    <ProductNDC>41250-222</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Meijer Effervescent Antacid And Pain Relief</ProprietaryName>
    <NonProprietaryName>Aspirin, Anhydrous Citric Acid, Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Meijer Distribution Inc</LabelerName>
    <SubstanceName>ASPIRIN; SODIUM BICARBONATE; ANHYDROUS CITRIC ACID</SubstanceName>
    <StrengthNumber>325; 1916; 1000</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Usesfor the temporary relief of. ■ minor aches and pains with heartburn, sour stomach or acid indigestion, and upset stomach associated with these symptoms. ■ headache, muscular aches, backache, and pain alone.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70436-110-36</NDCCode>
    <PackageDescription>30 mL in 1 VIAL (70436-110-36) </PackageDescription>
    <NDC11Code>70436-0110-36</NDC11Code>
    <ProductNDC>70436-110</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tobramycin</ProprietaryName>
    <NonProprietaryName>Tobramycin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217029</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>TOBRAMYCIN</SubstanceName>
    <StrengthNumber>1200</StrengthNumber>
    <StrengthUnit>mg/30mL</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Septicemia in the neonate, child, and adult caused by P. aeruginosa, E. coli, and Klebsiellasp. Lower respiratory tract infections caused by P. aeruginosa, Klebsiellasp, Enterobactersp, Serratiasp, E. coli, and S. aureus(penicillinase and non-penicillinase-producing strains). Serious central-nervous-system infections (meningitis) caused by susceptible organisms. Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiellasp, and Enterobactersp. Skin, bone, and skin structure infections caused by P. aeruginosa, Proteussp, E. coli, Klebsiellasp, Enterobactersp, and S. aureus. Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteussp (indole-positive and indole-negative), E. coli, Klebsiellasp, Enterobactersp, Serratiasp, S. aureus, Providenciasp, and Citrobactersp. Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGSbox above. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Tobramycin for Injection, USP is a white or off-white lyophilized porous cake for parenteral administration. Each vial contains tobramycin sulfate equivalent to 1200 mg of tobramycin; After reconstitution, each mL contains 40 mg of tobramycin, contains sulfuric acid and may contain sodium hydroxide for pH adjustment. Tobramycin sulfate is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O-[2,6-diamino-2,3,6-trideoxy-α-D- ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine, (2:5)(salt) and has the chemical formula (C 18H 37N 5O 9) 25H 2SO 4. The molecular weight is 1,425.39. The structural formula for tobramycin is as follows:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION: Directions for proper use of Pharmacy Bulk Package).</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-201-82</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70436-201-82)  / 20 mL in 1 VIAL, SINGLE-DOSE (70436-201-36) </PackageDescription>
    <NDC11Code>70436-0201-82</NDC11Code>
    <ProductNDC>70436-201</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240722</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217685</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE ANHYDROUS</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline for Injection, USP is indicated in infections caused by the following microorganisms: 1 Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsial pox and tick fevers)., 2 Mycoplasma pneumoniae(PPLO, Eaton Agent). , 3 Agents of psittacosis and ornithosis., 4 Agents of lymphogranuloma venereum and granuloma inguinale., 5 The spirochetal agent of relapsing fever ( Borrelia recurrentis). .</IndicationAndUsage>
    <Description>Doxycycline for Injection, USP is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate (doxycycline hydrochloride hemiethanolate hemihydrate). The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Each 100 mg vial contains: Doxycycline hyclate equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3. Each 200 mg vial contains: Doxycycline hyclate equivalent to 200 mg doxycycline; ascorbic acid 960 mg; mannitol 600 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-216-81</NDCCode>
    <PackageDescription>5 VIAL, MULTI-DOSE in 1 CARTON (70436-216-81)  / 30 mL in 1 VIAL, MULTI-DOSE (70436-216-36) </PackageDescription>
    <NDC11Code>70436-0216-81</NDC11Code>
    <ProductNDC>70436-216</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gadobutrol</ProprietaryName>
    <NonProprietaryName>Gadobutrol</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250416</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217480</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>GADOBUTROL</SubstanceName>
    <StrengthNumber>604.72</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):.</IndicationAndUsage>
    <Description>Gadobutrol injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging. The chemical name for gadobutrol is 10–[(1SR,2RS)–2,3–dihydroxy–1–hydroxymethylpropyl]–1,4,7,10–tetraazacyclododecane–1,4,7–triacetic acid, gadolinium complex. Gadobutrol has a molecular formula of C 18H 31GdN 4O 9and a molecular weight of 604.72. Gadobutrol injection is a sterile, clear, colorless to pale yellow solution containing 604.72 mg (1 mmol) of gadobutrol per mL as the active ingredient with 0.513 mg of calcobutrol sodium, 1.211 mg of trometamol, hydrochloric acid (for pH adjustment), and water for injection. Gadobutrol injection contains no preservatives. The main physicochemical properties of gadobutrol injection (1 mmol/mL solution for injection) are listed below. The thermodynamic stability constants for gadobutrol (log K thermand log K condat pH 7.4) are 21.8 and 15.3, respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-219-52</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70436-219-52)  / 30 mL in 1 VIAL, SINGLE-DOSE (70436-219-36) </PackageDescription>
    <NDC11Code>70436-0219-52</NDC11Code>
    <ProductNDC>70436-219</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iopamidol</ProprietaryName>
    <NonProprietaryName>Iopamidol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>20240415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217134</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>IOPAMIDOL</SubstanceName>
    <StrengthNumber>612</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iopamidol Injection, USP is a radiographic contrast agent indicated for. Intra-arterial Procedures*( 1.1) : 1 Cerebral arteriography in adults, 2 Peripheral arteriography in adults, 3 Selective visceral arteriography and aortography in adults, 4 Coronary arteriography and cardiac ventriculography in adults, 5 Angiocardiography in pediatric patients.</IndicationAndUsage>
    <Description>Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:. Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: 1 Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine., 2 Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine., 3 Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine., 4 Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-020-82</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (70436-020-82)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>70436-0020-82</NDC11Code>
    <ProductNDC>70436-020</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212332</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin Hydrochloride for Injection USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridansor S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride for Injection USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis(formerly Nocardia orientals). The chemical name for vancomycin hydrochloride is 3S- [3 R*,6 S*( S*),7 S*,22 S*, 23 R*,26 R*,36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9] oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-021-82</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (70436-021-82)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>70436-0021-82</NDC11Code>
    <ProductNDC>70436-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212332</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin Hydrochloride for Injection USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridansor S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride for Injection USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis(formerly Nocardia orientals). The chemical name for vancomycin hydrochloride is 3S- [3 R*,6 S*( S*),7 S*,22 S*, 23 R*,26 R*,36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9] oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
  </NDC>
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    <NDCCode>70436-022-82</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (70436-022-82)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
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    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
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    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215821</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin hydrochloride for injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride for injection has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection and other antibacterial drugs, vancomycin hydrochloride for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride for injection may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
    <Description>Vancomycin hydrochloride for injection, USP is an off-white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3 R*,6 S*( S*),7 S*,22 S*,23 R*,26R*, 36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl- a-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36, 37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadi-azacyclohexadecino[4,5- m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.</Description>
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  <NDC>
    <NDCCode>70436-023-82</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (70436-023-82)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215821</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
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    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin hydrochloride for injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride for injection has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection and other antibacterial drugs, vancomycin hydrochloride for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride for injection may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
    <Description>Vancomycin hydrochloride for injection, USP is an off-white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3 R*,6 S*( S*),7 S*,22 S*,23 R*,26R*, 36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl- a-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36, 37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadi-azacyclohexadecino[4,5- m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.</Description>
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    <PackageDescription>222 mL in 1 CAN (11523-7219-2) </PackageDescription>
    <NDC11Code>11523-7219-02</NDC11Code>
    <ProductNDC>11523-7219</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coppertone Sport Accuspray</ProprietaryName>
    <ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Oxybenzone</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140131</StartMarketingDate>
    <EndMarketingDate>20181201</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bayer HealthCare LLC.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE</SubstanceName>
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    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140131</StartMarketingDatePackage>
    <EndMarketingDatePackage>20181201</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70436-001-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70436-001-01) </PackageDescription>
    <NDC11Code>70436-0001-01</NDC11Code>
    <ProductNDC>70436-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209314</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
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    <LastUpdate>2025-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-Release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
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    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70436-001-02) </PackageDescription>
    <NDC11Code>70436-0001-02</NDC11Code>
    <ProductNDC>70436-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209314</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
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    <LastUpdate>2025-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-Release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-001-03</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70436-001-03) </PackageDescription>
    <NDC11Code>70436-0001-03</NDC11Code>
    <ProductNDC>70436-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209314</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-Release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-002-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70436-002-01) </PackageDescription>
    <NDC11Code>70436-0002-01</NDC11Code>
    <ProductNDC>70436-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209314</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-Release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-002-02</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70436-002-02) </PackageDescription>
    <NDC11Code>70436-0002-02</NDC11Code>
    <ProductNDC>70436-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209314</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-Release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-002-03</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70436-002-03) </PackageDescription>
    <NDC11Code>70436-0002-03</NDC11Code>
    <ProductNDC>70436-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209314</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-Release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-003-10</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (70436-003-10) </PackageDescription>
    <NDC11Code>70436-0003-10</NDC11Code>
    <ProductNDC>70436-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactulose Solution</ProprietaryName>
    <NonProprietaryName>Lactulose Solution</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209517</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LACTULOSE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/15mL</StrengthUnit>
    <Pharm_Classes>Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70436-003-11</NDCCode>
    <PackageDescription>120 mL in 1 BOTTLE (70436-003-11) </PackageDescription>
    <NDC11Code>70436-0003-11</NDC11Code>
    <ProductNDC>70436-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactulose Solution</ProprietaryName>
    <NonProprietaryName>Lactulose Solution</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209517</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LACTULOSE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/15mL</StrengthUnit>
    <Pharm_Classes>Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70436-003-13</NDCCode>
    <PackageDescription>200 mL in 1 BOTTLE (70436-003-13) </PackageDescription>
    <NDC11Code>70436-0003-13</NDC11Code>
    <ProductNDC>70436-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactulose Solution</ProprietaryName>
    <NonProprietaryName>Lactulose Solution</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209517</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LACTULOSE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/15mL</StrengthUnit>
    <Pharm_Classes>Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70436-003-14</NDCCode>
    <PackageDescription>300 mL in 1 BOTTLE (70436-003-14) </PackageDescription>
    <NDC11Code>70436-0003-14</NDC11Code>
    <ProductNDC>70436-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactulose Solution</ProprietaryName>
    <NonProprietaryName>Lactulose Solution</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209517</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LACTULOSE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/15mL</StrengthUnit>
    <Pharm_Classes>Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70436-003-16</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE (70436-003-16) </PackageDescription>
    <NDC11Code>70436-0003-16</NDC11Code>
    <ProductNDC>70436-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactulose Solution</ProprietaryName>
    <NonProprietaryName>Lactulose Solution</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209517</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LACTULOSE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/15mL</StrengthUnit>
    <Pharm_Classes>Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70436-003-18</NDCCode>
    <PackageDescription>1000 mL in 1 BOTTLE (70436-003-18) </PackageDescription>
    <NDC11Code>70436-0003-18</NDC11Code>
    <ProductNDC>70436-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lactulose Solution</ProprietaryName>
    <NonProprietaryName>Lactulose Solution</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209517</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LACTULOSE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/15mL</StrengthUnit>
    <Pharm_Classes>Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70436-004-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70436-004-06) </PackageDescription>
    <NDC11Code>70436-0004-06</NDC11Code>
    <ProductNDC>70436-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Galantamine</ProprietaryName>
    <NonProprietaryName>Galantamine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170802</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077604</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.</IndicationAndUsage>
    <Description>Galantamine Tablets USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C 17H 21NO 3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. Galantamine Tablets USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide. The 4 mg tablets contain polyethylene glycol and polysorbate 80. The 8 mg tablets contain D&amp;C red #27, FD&amp;C blue #1, and triacetin. The 12 mg tablets contain FD&amp;C yellow # 6, iron oxide yellow, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-005-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70436-005-06) </PackageDescription>
    <NDC11Code>70436-0005-06</NDC11Code>
    <ProductNDC>70436-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Galantamine</ProprietaryName>
    <NonProprietaryName>Galantamine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170802</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077604</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.</IndicationAndUsage>
    <Description>Galantamine Tablets USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C 17H 21NO 3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. Galantamine Tablets USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide. The 4 mg tablets contain polyethylene glycol and polysorbate 80. The 8 mg tablets contain D&amp;C red #27, FD&amp;C blue #1, and triacetin. The 12 mg tablets contain FD&amp;C yellow # 6, iron oxide yellow, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-006-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70436-006-06) </PackageDescription>
    <NDC11Code>70436-0006-06</NDC11Code>
    <ProductNDC>70436-006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Galantamine</ProprietaryName>
    <NonProprietaryName>Galantamine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170802</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077604</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.</IndicationAndUsage>
    <Description>Galantamine Tablets USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C 17H 21NO 3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. Galantamine Tablets USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide. The 4 mg tablets contain polyethylene glycol and polysorbate 80. The 8 mg tablets contain D&amp;C red #27, FD&amp;C blue #1, and triacetin. The 12 mg tablets contain FD&amp;C yellow # 6, iron oxide yellow, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-007-04</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70436-007-04) </PackageDescription>
    <NDC11Code>70436-0007-04</NDC11Code>
    <ProductNDC>70436-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cinacalcet Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cinacalcet Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190306</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210207</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals</LabelerName>
    <SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cinacalcet tablets are a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1), 2  Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis , 3 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 4 Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3).</IndicationAndUsage>
    <Description>Cinacalcet Tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N·HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated, tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive IngredientsThe following are the inactive ingredients in cinacalcet tablets: colloidal silicon dioxide, corn/maize starch, crospovidone, FD&amp;C Blue #2/Indigo carmine AL, iron oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pre-gelatinized starch, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-008-04</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70436-008-04) </PackageDescription>
    <NDC11Code>70436-0008-04</NDC11Code>
    <ProductNDC>70436-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cinacalcet Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cinacalcet Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190306</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210207</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals</LabelerName>
    <SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cinacalcet tablets are a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1), 2  Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis , 3 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 4 Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3).</IndicationAndUsage>
    <Description>Cinacalcet Tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N·HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated, tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive IngredientsThe following are the inactive ingredients in cinacalcet tablets: colloidal silicon dioxide, corn/maize starch, crospovidone, FD&amp;C Blue #2/Indigo carmine AL, iron oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pre-gelatinized starch, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>70436-009-04</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70436-009-04) </PackageDescription>
    <NDC11Code>70436-0009-04</NDC11Code>
    <ProductNDC>70436-009</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cinacalcet Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cinacalcet Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190306</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210207</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals</LabelerName>
    <SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cinacalcet tablets are a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1), 2  Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis , 3 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 4 Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3).</IndicationAndUsage>
    <Description>Cinacalcet Tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N·HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated, tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive IngredientsThe following are the inactive ingredients in cinacalcet tablets: colloidal silicon dioxide, corn/maize starch, crospovidone, FD&amp;C Blue #2/Indigo carmine AL, iron oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pre-gelatinized starch, titanium dioxide and triacetin.</Description>
  </NDC>
</NDCList>