RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>21695-549-22</NDCCode>
    <PackageDescription>22.5 mL in 1 BOTTLE (21695-549-22)</PackageDescription>
    <NDC11Code>21695-0549-22</NDC11Code>
    <ProductNDC>21695-549</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065419</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp.</LabelerName>
    <SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Azithromycin for oral suspension is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.</IndicationAndUsage>
    <Description>Azithromycin for oral suspension, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, 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. Azithromycin has the following structural formula. C38H72N2O12 M. W. 749.00. Azithromycin, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.02. 5 mL of constituted suspension of azithromycin for oral suspension, 100 mg/5 mL and 200 mg/5 mL, contains 6 mg of sodium. Azithromycin for oral suspension, USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: arabic gum, artificial aromatic substances, ethyl vanillin, FD&amp;C Red #40, hydroxypropyl cellulose, maltodextrin, nature aromatic substances, nature identical aromatic substances, sucrose, tribasic sodium phosphate dodecahydrate, vanillin, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-188-22</NDCCode>
    <PackageDescription>22 g in 1 TUBE (21695-188-22)</PackageDescription>
    <NDC11Code>21695-0188-22</NDC11Code>
    <ProductNDC>21695-188</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mupirocin</ProprietaryName>
    <NonProprietaryName>Mupirocin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20051130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065192</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp.</LabelerName>
    <SubstanceName>MUPIROCIN</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Mupirocin ointment, 2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes.</IndicationAndUsage>
    <Description>Each gram of mupirocin ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid,ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C26H44O9 and the molecular weight is 500.63. The chemical structure is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-549-15</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE (21695-549-15)</PackageDescription>
    <NDC11Code>21695-0549-15</NDC11Code>
    <ProductNDC>21695-549</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065419</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp.</LabelerName>
    <SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Azithromycin for oral suspension is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.</IndicationAndUsage>
    <Description>Azithromycin for oral suspension, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, 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. Azithromycin has the following structural formula. C38H72N2O12 M. W. 749.00. Azithromycin, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.02. 5 mL of constituted suspension of azithromycin for oral suspension, 100 mg/5 mL and 200 mg/5 mL, contains 6 mg of sodium. Azithromycin for oral suspension, USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: arabic gum, artificial aromatic substances, ethyl vanillin, FD&amp;C Red #40, hydroxypropyl cellulose, maltodextrin, nature aromatic substances, nature identical aromatic substances, sucrose, tribasic sodium phosphate dodecahydrate, vanillin, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-549-30</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (21695-549-30)</PackageDescription>
    <NDC11Code>21695-0549-30</NDC11Code>
    <ProductNDC>21695-549</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065419</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp.</LabelerName>
    <SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Azithromycin for oral suspension is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.</IndicationAndUsage>
    <Description>Azithromycin for oral suspension, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, 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. Azithromycin has the following structural formula. C38H72N2O12 M. W. 749.00. Azithromycin, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.02. 5 mL of constituted suspension of azithromycin for oral suspension, 100 mg/5 mL and 200 mg/5 mL, contains 6 mg of sodium. Azithromycin for oral suspension, USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: arabic gum, artificial aromatic substances, ethyl vanillin, FD&amp;C Red #40, hydroxypropyl cellulose, maltodextrin, nature aromatic substances, nature identical aromatic substances, sucrose, tribasic sodium phosphate dodecahydrate, vanillin, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-549-31</NDCCode>
    <PackageDescription>31 TABLET, FILM COATED in 1 BOTTLE (10544-549-31)</PackageDescription>
    <NDC11Code>10544-0549-31</NDC11Code>
    <ProductNDC>10544-549</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prenatal Plus</ProprietaryName>
    <NonProprietaryName>Vitamin A Acetate, Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin,</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101209</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>VITAMIN A ACETATE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE</SubstanceName>
    <StrengthNumber>3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2</StrengthNumber>
    <StrengthUnit>[iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception.</IndicationAndUsage>
    <Description>Prenatal Plus Vitamin and Mineral Tablet is an Tan-Yellow colored, modified oval biconvex film coated tablet debossed G12 on one side, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.Each Prenatal Plus tablet Contains:Vitamin A (Acetate and Beta Carotene) .......................................4000 I.U. Vitamin C (Ascorbic acid)……………………………………...........….120 mgVitamin D-3 (Cholecalciferol)……………….....................................400 I.U.Vitamin E (dl- Alpha Tocopheryl Acetate)……………………...............22 mgThiamine (Vitamin B-1 from Thiamine Mononitrate………............…1.84 mgRiboflavin (Vitamin B-2)………………………………………...............…3 mgNiacin(Niacinamide)……………………………………………………....  20 mgVitamin B-6 (Pyridoxine HCl)…………………………………................10 mgFolic Acid……………………………………………………............……...1 mgVitamin B-12 (Cyanocobalamin)……………………………................12 mcgCalcium (Calcium Carbonate)……………………………….........…....200 mgIron (Ferrous Fumarate)………………………………………...........…...27 mgZinc (Zinc Oxide)………………………………………………...........…..25 mgCopper (Cupric Oxide)…………………………………………...........… ..2 mgOther ingredients: Ascorbyl Palmitate, Butylated Hydroxytoluene, Croscarmellose sodium, Dicalcium phosphate Dihydrate, DL-alpha-tocopherol, FD&amp;C Blue # 2 lake, FD&amp;C Red # 40, FD&amp;C Red # 40 lake, FD&amp;C yellow # 5, FD&amp;C yellow # 6, FD&amp;C yellow # 6 lake, Gelatin, Hypromellose, Magnesium stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized corn starch, Propylene Glycol, Silica, Sodium Ascorbate, Sodium Benzoate, Sorbic Acid, Starch, Stearic Acid, Sucrose, SUnflower Oil, Titanium dioxide, Triacetin, Triglycerides.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-549-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (43598-549-10)  / 100 mL in 1 VIAL (43598-549-52) </PackageDescription>
    <NDC11Code>43598-0549-10</NDC11Code>
    <ProductNDC>43598-549</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propofol Injectable Emulsion</ProprietaryName>
    <NonProprietaryName>Propofol Injectable Emulsion</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205067</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories, Inc.</LabelerName>
    <SubstanceName>PROPOFOL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for.  Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age.  Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age.  Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients.  Sedation for Adult Patients in Combination with Regional Anesthesia.  Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients. Limitations of Use. Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use (8.4)]. Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)]. Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)].</IndicationAndUsage>
    <Description>Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight:178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 4.5 to 7.4. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), and benzyl alcohol (0.15%); with sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion is isotonic and has a pH of 5.5 to 7.4.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-605-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (49281-605-01)  *  .5 mL in 1 VIAL, SINGLE-DOSE (49281-606-58)  *  .6 mL in 1 VIAL, SINGLE-DOSE (49281-549-58) </PackageDescription>
    <NDC11Code>49281-0605-01</NDC11Code>
    <ProductNDC>49281-605</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Dengvaxia</ProprietaryName>
    <NonProprietaryName>Dengue Tetravalent Vaccine, Live</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20190501</StartMarketingDate>
    <EndMarketingDate>20260831</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125682</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190501</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DENGVAXIA® (Dengue Tetravalent Vaccine, Live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4. DENGVAXIA is approved for use in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.</IndicationAndUsage>
    <Description>DENGVAXIA (Dengue Tetravalent Vaccine, Live) is a sterile suspension for subcutaneous injection. DENGVAXIA is supplied as a vial of lyophilized vaccine antigen, which must be reconstituted at the time of use with 0.6 mL from the accompanying vial of diluent (0.4% sodium chloride). After reconstitution, DENGVAXIA is a clear, colorless suspension (trace amounts of white to translucent proteinaceous particles may be present). [See Dosage and Administration (2.3).]. After reconstitution, each 0.5 mL dose of DENGVAXIA contains 4.5 – 6.0 log10 CCID50 of each of the chimeric yellow fever dengue (CYD) virus serotypes 1, 2, 3, and 4. Each 0.5 mL dose is formulated to contain 2 mg sodium chloride and the following ingredients as stabilizers: 0.56 mg essential amino acids (including L-phenylalanine), 0.2 mg non-essential amino acids, 2.5 mg L-arginine hydrochloride, 18.75 mg sucrose, 13.75 mg D-trehalose dihydrate, 9.38 mg D-sorbitol, 0.18 mg trometamol, and 0.63 mg urea. Each of the four CYD viruses (CYD-1, CYD-2, CYD-3, and CYD-4) in DENGVAXIA was constructed using recombinant DNA technology by replacing the sequences encoding the pre-membrane (prM) and envelope (E) proteins in the yellow fever (YF) 17D204 vaccine virus genome with those encoding for the homologous sequences of dengue virus serotypes 1, 2, 3, and 4, respectively. Each CYD virus is cultured separately in Vero cells (African Green Monkey kidney) under serum-free conditions, harvested from the supernatant of the Vero cells and purified by membrane chromatography and ultrafiltration. The purified and concentrated harvest of each CYD virus is then diluted in a stabilizer solution to produce the four monovalent drug substances. The final bulk product is a mixture of the four monovalent drug substances diluted in the stabilizer solution. The final bulk product is sterilized by filtration at 0.22 µm, filled into vials and freeze-dried. DENGVAXIA does not contain preservative. The vial stoppers for the Lyophilized Vaccine Antigen and Diluent vials of DENGVAXIA are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>68084-549-21</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21)  / 1 CAPSULE in 1 BLISTER PACK (68084-549-11) </PackageDescription>
    <NDC11Code>68084-0549-21</NDC11Code>
    <ProductNDC>68084-549</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temazepam</ProprietaryName>
    <NonProprietaryName>Temazepam</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120801</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018163</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>TEMAZEPAM</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temazepam Capsules USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
    <Description>Temazepam Capsules USP are benzodiazepine hypnotic agents. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2 H-1,4-benzodiazepin-2-one, and the structural formula is:. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg, and 30 mg CapsulesActive Ingredient:temazepam USP. 7.5 mg CapsulesInactive Ingredients: FD&amp;C Blue #1, FD&amp;C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. May also include: n-butyl alcohol, iron oxide red, shellac, shellac glaze, SD-35A alcohol. 15 mg CapsulesInactive Ingredients: FD&amp;C Blue #1, FD&amp;C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. May also include: n-butyl alcohol, FD&amp;C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol. 22.5 mg CapsulesInactive Ingredients: FD&amp;C Blue #1, FD&amp;C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. May also include: n-butyl alcohol, FD&amp;C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol. 30 mg CapsulesInactive Ingredients: FD&amp;C Blue #1, FD&amp;C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. May also include: n-butyl alcohol, FD&amp;C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-091-10</NDCCode>
    <PackageDescription>10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-091-10)</PackageDescription>
    <NDC11Code>21695-0091-10</NDC11Code>
    <ProductNDC>21695-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nexium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110708</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021153</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>NEXIUM is a proton pump inhibitor indicated for the following: 1  Treatment of gastroesophageal reflux disease (GERD) (1.1), 2  Risk reduction of NSAID-associated gastric ulcer (1.2), 3  H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4  Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
    <Description>The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&amp;C Blue #1, FD&amp;C Red #40, D&amp;C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&amp;C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-091-30</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-091-30)</PackageDescription>
    <NDC11Code>21695-0091-30</NDC11Code>
    <ProductNDC>21695-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nexium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110708</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021153</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>NEXIUM is a proton pump inhibitor indicated for the following: 1  Treatment of gastroesophageal reflux disease (GERD) (1.1), 2  Risk reduction of NSAID-associated gastric ulcer (1.2), 3  H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4  Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
    <Description>The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&amp;C Blue #1, FD&amp;C Red #40, D&amp;C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&amp;C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-091-60</NDCCode>
    <PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-091-60)</PackageDescription>
    <NDC11Code>21695-0091-60</NDC11Code>
    <ProductNDC>21695-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nexium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110708</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021153</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>NEXIUM is a proton pump inhibitor indicated for the following: 1  Treatment of gastroesophageal reflux disease (GERD) (1.1), 2  Risk reduction of NSAID-associated gastric ulcer (1.2), 3  H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4  Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
    <Description>The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&amp;C Blue #1, FD&amp;C Red #40, D&amp;C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&amp;C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-092-15</NDCCode>
    <PackageDescription>15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-092-15)</PackageDescription>
    <NDC11Code>21695-0092-15</NDC11Code>
    <ProductNDC>21695-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nexium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110708</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021153</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>NEXIUM is a proton pump inhibitor indicated for the following: 1  Treatment of gastroesophageal reflux disease (GERD) (1.1), 2  Risk reduction of NSAID-associated gastric ulcer (1.2), 3  H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4  Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
    <Description>The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&amp;C Blue #1, FD&amp;C Red #40, D&amp;C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&amp;C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-092-30</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-092-30)</PackageDescription>
    <NDC11Code>21695-0092-30</NDC11Code>
    <ProductNDC>21695-092</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nexium</ProprietaryName>
    <NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110708</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021153</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>NEXIUM is a proton pump inhibitor indicated for the following: 1  Treatment of gastroesophageal reflux disease (GERD) (1.1), 2  Risk reduction of NSAID-associated gastric ulcer (1.2), 3  H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4  Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
    <Description>The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&amp;C Blue #1, FD&amp;C Red #40, D&amp;C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&amp;C Yellow #10. Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-108-15</NDCCode>
    <PackageDescription>15 TABLET, DELAYED RELEASE in 1 BOTTLE (21695-108-15)</PackageDescription>
    <NDC11Code>21695-0108-15</NDC11Code>
    <ProductNDC>21695-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Protonix</ProprietaryName>
    <NonProprietaryName>Pantoprazoel Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010828</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020987</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for.</IndicationAndUsage>
    <Description>The active ingredient in PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. PROTONIX (pantoprazole sodium) is supplied as a for delayed-release oral suspension, available in one strength (40 mg), and as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each PROTONIX (pantoprazole sodium) Delayed-Release Tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. PROTONIX Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2. PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension, 40 mg, contains the active ingredient pantoprazole sodium sesquihydrate in the form of enteric‑coated granules in unit dose packets. Each unit dose packet contains enteric-coated granules containing 45.1 mg pantoprazole sodium sesquihydrate (equivalent to 40 mg of pantoprazole) with the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-424-01</NDCCode>
    <PackageDescription>10 mL in 1 VIAL (21695-424-01)</PackageDescription>
    <NDC11Code>21695-0424-01</NDC11Code>
    <ProductNDC>21695-424</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sterile Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20081231</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065397</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC],Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-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 is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride 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, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride 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 has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. The parenteral form of Sterile Vancomycin Hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin 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>Sterile Vancomycin Hydrochloride, USP is a lyophilized powder, for preparing intravenous (IV) infusions. Each vial contains the equivalent of 500 mg or 1 gram vancomycin base; 500 mg of base is equivalent to 0.34 mmol. Vancomycin hydrochloride is an off-white to tan colored lyophilized powder. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. When reconstituted with Sterile Water for Injection, USP it forms a clear solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin hydrochloride is prepared as a solution and lyophilized in its final container. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The molecular formula is C66H75Cl2N9O24   HCl and the molecular weight is 1,485.71. Vancomycin Hydrochloride has the following chemical designation. (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino- 2,3,6-trideoxy-3-C-methyl-(-L-lyxo-hexopyranosyl)- (-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-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-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. Its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-527-15</NDCCode>
    <PackageDescription>15 CAPSULE in 1 BOTTLE (21695-527-15)</PackageDescription>
    <NDC11Code>21695-0527-15</NDC11Code>
    <ProductNDC>21695-527</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rifampin</ProprietaryName>
    <NonProprietaryName>Rifampin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970528</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064150</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>RIFAMPIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Rifamycin Antibacterial [EPC],Rifamycins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin capsule and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
    <Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl) imino]-methyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino) naphtho [2,1-b]furan-1,11(2H)-dione 21-acetate. The structural formula is. Rifampin capsules for oral administration contain 150 mg or 300 mg rifampin per capsule. In addition, the 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&amp;C Yellow #10 aluminum lake, docusate sodium, FD&amp;C blue #1, calcium stearate, D&amp;C yellow #10 aluminum lake, FD&amp;C blue #1, FD&amp;C blue #1 aluminum lake, FD&amp;C blue #2 aluminum lake, FD&amp;C red #40, FD&amp;C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain, D&amp;C yellow #10, D&amp;C Red #28.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-527-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE (21695-527-20)</PackageDescription>
    <NDC11Code>21695-0527-20</NDC11Code>
    <ProductNDC>21695-527</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rifampin</ProprietaryName>
    <NonProprietaryName>Rifampin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970528</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064150</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>RIFAMPIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Rifamycin Antibacterial [EPC],Rifamycins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin capsule and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
    <Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl) imino]-methyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino) naphtho [2,1-b]furan-1,11(2H)-dione 21-acetate. The structural formula is. Rifampin capsules for oral administration contain 150 mg or 300 mg rifampin per capsule. In addition, the 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&amp;C Yellow #10 aluminum lake, docusate sodium, FD&amp;C blue #1, calcium stearate, D&amp;C yellow #10 aluminum lake, FD&amp;C blue #1, FD&amp;C blue #1 aluminum lake, FD&amp;C blue #2 aluminum lake, FD&amp;C red #40, FD&amp;C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain, D&amp;C yellow #10, D&amp;C Red #28.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-527-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (21695-527-30)</PackageDescription>
    <NDC11Code>21695-0527-30</NDC11Code>
    <ProductNDC>21695-527</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rifampin</ProprietaryName>
    <NonProprietaryName>Rifampin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970528</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064150</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>RIFAMPIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Rifamycin Antibacterial [EPC],Rifamycins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin capsule and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
    <Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl) imino]-methyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino) naphtho [2,1-b]furan-1,11(2H)-dione 21-acetate. The structural formula is. Rifampin capsules for oral administration contain 150 mg or 300 mg rifampin per capsule. In addition, the 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&amp;C Yellow #10 aluminum lake, docusate sodium, FD&amp;C blue #1, calcium stearate, D&amp;C yellow #10 aluminum lake, FD&amp;C blue #1, FD&amp;C blue #1 aluminum lake, FD&amp;C blue #2 aluminum lake, FD&amp;C red #40, FD&amp;C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain, D&amp;C yellow #10, D&amp;C Red #28.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-678-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (21695-678-30)</PackageDescription>
    <NDC11Code>21695-0678-30</NDC11Code>
    <ProductNDC>21695-678</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Digoxin</ProprietaryName>
    <NonProprietaryName>Digoxin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075659</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>DIGOXIN</SubstanceName>
    <StrengthNumber>.125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-10</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.</IndicationAndUsage>
    <Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as(3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. lts molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-770-01</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 POUCH (21695-770-01)  &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>21695-0770-01</NDC11Code>
    <ProductNDC>21695-770</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tri-sprintec</ProprietaryName>
    <NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20110125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075808</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tri-Sprintec Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec Tablets are indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In four clinical trials with norgestimate and ethinyl estradiol, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on norgestimate and ethinyl estradiol, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years. In two double-blind, placebo-controlled, six month, multicenter clinical trials, norgestimate and ethinyl estradiol showed a statistically significant decrease in inflammatory lesion count and total lesion count (TABLE II). The adverse reaction profile of norgestimate and ethinyl estradiol from these two controlled clinical trials is consistent with what has been noted from previous studies involving norgestimate and ethinyl estradiol and are the known risks associated with oral contraceptives.</IndicationAndUsage>
    <Description>Tri-Sprintec® Tablets are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Each gray tablet contains 0.18 mg of the progestational compound, norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&amp;C blue no. 2, FD&amp;C red no. 40, FD&amp;C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized starch. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&amp;C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each blue tablet contains 0.25 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&amp;C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formula is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-771-30</NDCCode>
    <PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (21695-771-30)</PackageDescription>
    <NDC11Code>21695-0771-30</NDC11Code>
    <ProductNDC>21695-771</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101012</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077056</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
    <Description>The active ingredient in pantoprazole sodium delayed-release tablets USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. The structural formula is. C16H14F2N3NaO4S1.5 H2O M.W. 432.4. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5.0 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet USP contains 45.1 mg or 22.6 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium carbonate, calcium stearate, D&amp;C yellow #10 aluminum lake, FD&amp;C yellow #6 aluminum lake, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, low-substituted hydroxypropyl cellulose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, shellac glaze, sodium carbonate anhydrous, stearic acid, talc, titanium dioxide, and triethyl citrate. The imprinting ink may contain antifoam DC 1510, propylene glycol, and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>0023-6498-01</NDCCode>
    <PackageDescription>1 PACKET in 1 BOX (0023-6498-01)  / 1 TABLET in 1 PACKET</PackageDescription>
    <NDC11Code>00023-6498-01</NDC11Code>
    <ProductNDC>0023-6498</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ubrelvy</ProprietaryName>
    <NonProprietaryName>Ubrogepant</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA211765</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>UBROGEPANT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191223</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. UBRELVY is not indicated for the preventive treatment of migraine.</IndicationAndUsage>
    <Description>The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula. The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water. UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0023-6498-04</NDCCode>
    <PackageDescription>4 PACKET in 1 BOX (0023-6498-04)  / 1 TABLET in 1 PACKET</PackageDescription>
    <NDC11Code>00023-6498-04</NDC11Code>
    <ProductNDC>0023-6498</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ubrelvy</ProprietaryName>
    <NonProprietaryName>Ubrogepant</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA211765</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
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    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-15</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191223</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. UBRELVY is not indicated for the preventive treatment of migraine.</IndicationAndUsage>
    <Description>The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula. The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water. UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.</Description>
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    <IndicationAndUsage>UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. UBRELVY is not indicated for the preventive treatment of migraine.</IndicationAndUsage>
    <Description>The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula. The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water. UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.</Description>
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    <LabelerName>Allergan, Inc.</LabelerName>
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    <IndicationAndUsage>UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. UBRELVY is not indicated for the preventive treatment of migraine.</IndicationAndUsage>
    <Description>The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula. The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water. UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.</Description>
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    <PackageDescription>30 PACKET in 1 BOX (0023-6498-30)  / 1 TABLET in 1 PACKET (0023-6498-02) </PackageDescription>
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    <ProprietaryName>Ubrelvy</ProprietaryName>
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    <ApplicationNumber>NDA211765</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>UBROGEPANT</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
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    <LastUpdate>2026-09-15</LastUpdate>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. UBRELVY is not indicated for the preventive treatment of migraine.</IndicationAndUsage>
    <Description>The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula. The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water. UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.</Description>
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    <PackageDescription>1 PACKET in 1 BOX (0023-6501-01)  / 1 TABLET in 1 PACKET</PackageDescription>
    <NDC11Code>00023-6501-01</NDC11Code>
    <ProductNDC>0023-6501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ubrelvy</ProprietaryName>
    <NonProprietaryName>Ubrogepant</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
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    <StartMarketingDate>20191223</StartMarketingDate>
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    <ApplicationNumber>NDA211765</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>UBROGEPANT</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191223</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. UBRELVY is not indicated for the preventive treatment of migraine.</IndicationAndUsage>
    <Description>The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula. The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water. UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.</Description>
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    <NDCCode>0023-6501-10</NDCCode>
    <PackageDescription>10 PACKET in 1 BOX (0023-6501-10)  / 1 TABLET in 1 PACKET (0023-6501-02) </PackageDescription>
    <NDC11Code>00023-6501-10</NDC11Code>
    <ProductNDC>0023-6501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ubrelvy</ProprietaryName>
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    <DosageFormName>TABLET</DosageFormName>
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    <ApplicationNumber>NDA211765</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>UBROGEPANT</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. UBRELVY is not indicated for the preventive treatment of migraine.</IndicationAndUsage>
    <Description>The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula. The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water. UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.</Description>
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    <PackageDescription>16 PACKET in 1 BOX (0023-6501-16)  / 1 TABLET in 1 PACKET (0023-6501-02) </PackageDescription>
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    <ProprietaryName>Ubrelvy</ProprietaryName>
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    <ApplicationNumber>NDA211765</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
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    <LastUpdate>2026-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. UBRELVY is not indicated for the preventive treatment of migraine.</IndicationAndUsage>
    <Description>The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula. The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water. UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.</Description>
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    <LabelerName>Allergan, Inc.</LabelerName>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. UBRELVY is not indicated for the preventive treatment of migraine.</IndicationAndUsage>
    <Description>The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula. The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water. UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.</Description>
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