RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "58160-819-12",
      "PackageDescription": "1 KIT in 1 CARTON (58160-819-12)  *  .5 mL in 1 VIAL (58160-828-01)  *  .5 mL in 1 VIAL (58160-829-01) ",
      "NDC11Code": "58160-0819-12",
      "ProductNDC": "58160-819",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Shingrix",
      "NonProprietaryName": "Zoster Vaccine Recombinant, Adjuvanted",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20171020",
      "EndMarketingDate": "20250823",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125614",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20171020",
      "EndMarketingDatePackage": "20250823",
      "SamplePackage": "N",
      "IndicationAndUsage": "SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles): 1 in adults aged 50 years and older., 2 in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.",
      "Description": "SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) is a sterile injectable suspension for intramuscular use that contains recombinant varicella zoster virus gE antigen adjuvanted with AS01B. The vial and vial presentation is supplied as a vial of lyophilized recombinant varicella zoster virus surface gE antigen component (Lyophilized gE Antigen Component), which must be reconstituted at the time of use with the accompanying vial of AS01B (Adjuvant Suspension Component) to form SHINGRIX. The SHINGRIX prefilled syringe presentation does not require reconstitution. SHINGRIX is a sterile, opalescent, colorless to pale brownish liquid. The gE antigen is obtained by culturing genetically engineered Chinese Hamster Ovary cells, which carry a truncated gE gene, in media containing amino acids, with no albumin, antibiotics, or animal‑derived proteins. The gE protein is purified by several chromatographic steps and formulated with excipients. The AS01B adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) derived from Salmonella minnesota and QS‑21, a saponin purified from Quillaja saponaria Molina plant extract, and is combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. Each 0.5‑mL dose is formulated to contain 50 mcg of the recombinant gE antigen, 50 mcg of MPL, and 50 mcg of QS‑21. Each dose also contains 20 mg of sucrose, 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. SHINGRIX does not contain preservatives. Each dose may also contain residual amounts of host cell proteins (≤3.0%) and DNA (≤2.1 picograms) from the manufacturing process. In the vial and vial presentation, the vial stoppers are not made with natural rubber latex. In the prefilled syringe presentation, the tip cap and rubber plunger stopper are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-882-12",
      "PackageDescription": "1 KIT in 1 CARTON (58160-882-12)  *  .5 mL in 1 VIAL (58160-719-03)  *  .5 mL in 1 SYRINGE (58160-749-07) ",
      "NDC11Code": "58160-0882-12",
      "ProductNDC": "58160-882",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Arexvy",
      "NonProprietaryName": "Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20260430",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125775",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260430",
      "SamplePackage": "N",
      "IndicationAndUsage": "AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: 1 individuals 60 years of age and older;, 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
      "Description": "AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre‑fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial or prefilled syringe of AS01E adjuvant as the Adjuvant Suspension Component. The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal‑derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. The AS01E adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS‑21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution of the vial and vial presentation, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. After reconstitution of the vial and prefilled syringe presentation, each dose (approximately 0.5 mL) is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 16.3 mg of Trehalose, 4.4 mg of sodium chloride, 0.87 mg of potassium dihydrogen phosphate, 0.29 mg of dipotassium phosphate, 0.20 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY contains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process. The stopper of the vial containing Lyophilized Antigen Component or Adjuvant Suspension Component and the tip cap and plunger stopper of the prefilled syringe containing Adjuvant Suspension Component are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-964-12",
      "PackageDescription": "1 KIT in 1 CARTON (58160-964-12)  *  1 mL in 1 VIAL, GLASS (58160-966-01)  *  1 mL in 1 SYRINGE (58160-967-02) ",
      "NDC11Code": "58160-0964-12",
      "ProductNDC": "58160-964",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Rabavert",
      "NonProprietaryName": "Rabies Vaccine",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20161219",
      "EndMarketingDate": "20240131",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103334",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161219",
      "EndMarketingDatePackage": "20240131",
      "SamplePackage": "N",
      "IndicationAndUsage": "RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. Usually an immunization series is initiated and completed with 1 vaccine product. No clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. However, for booster immunization, RabAvert was shown to elicit protective antibody level responses in persons tested who received a primary series with HDCV.4,11.",
      "Description": "RabAvert Rabies Vaccine produced by GlaxoSmithKline GmbH is a sterile, freeze-dried vaccine obtained by growing the fixed-virus strain Flury Low Egg Passage (LEP) in primary cultures of chicken fibroblasts. The strain Flury LEP was obtained from American Type Culture Collection as the 59th egg passage. The growth medium for propagation of the virus is a synthetic cell culture medium with the addition of human albumin, polygeline (processed bovine gelatin), and antibiotics. The virus is inactivated with β-propiolactone and further processed by zonal centrifugation in a sucrose density gradient. The vaccine is lyophilized after addition of a stabilizer solution that consists of buffered polygeline and potassium glutamate. One dose of reconstituted vaccine contains ≤12 mg polygeline (processed bovine gelatin), ≤0.3 mg human serum albumin, 1 mg potassium glutamate, and 0.3 mg sodium EDTA. Small quantities of bovine serum are used in the cell culture process. Bovine components originate only from the United States, Australia, and New Zealand. Minimal amounts of chicken protein may be present in the final product; ovalbumin content is ≤3 ng/dose (1 mL), based on ELISA. Antibiotics (neomycin, chlortetracycline, amphotericin B) added during cell and virus propagation are largely removed during subsequent steps in the manufacturing process. In the final vaccine, neomycin is present at ≤10 mcg, chlortetracycline at ≤200 ng, and amphotericin B at ≤20 ng per dose. RabAvert is intended for intramuscular (IM) injection. The vaccine contains no preservative and should be used immediately after reconstitution with the supplied Sterile Diluent for RabAvert (Water for Injection). The potency of the final product is determined by the National Institutes of Health (NIH) mouse potency test using the United States (US) reference standard. The potency of 1 dose (1.0 mL) of RabAvert is at least 2.5 IU of rabies antigen. RabAvert is a white, freeze-dried vaccine for reconstitution with the diluent prior to use; the reconstituted vaccine is a clear to slightly opalescent, colorless to slightly pink suspension."
    },
    {
      "NDCCode": "30142-819-12",
      "PackageDescription": "236 mL in 1 TUBE (30142-819-12) ",
      "NDC11Code": "30142-0819-12",
      "ProductNDC": "30142-819",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Simple Truth Mineral Based Spf 50 Sunscreen",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180920",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "THE KROGER COMPANY",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "30; 150",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2023-10-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180920",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "37000-819-12",
      "PackageDescription": "1 TUBE in 1 CARTON (37000-819-12)  > 164 g in 1 TUBE",
      "NDC11Code": "37000-0819-12",
      "ProductNDC": "37000-819",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Crest Complete Multi-benefit",
      "ProprietaryNameSuffix": "Whitening Plus Deep Clean",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20110701",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-27"
    },
    {
      "NDCCode": "59779-819-58",
      "PackageDescription": "12 CAN in 1 CASE (59779-819-58)  > 121.6 g in 1 CAN (59779-819-57)",
      "NDC11Code": "59779-0819-58",
      "ProductNDC": "59779-819",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sensitive Tooth Paste",
      "ProprietaryNameSuffix": "Multi Action",
      "NonProprietaryName": "Fluoride",
      "DosageFormName": "GEL",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20111213",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
      "StrengthNumber": "5; .15",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "63868-819-12",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (63868-819-12)  / 6 TABLET in 1 BLISTER PACK",
      "NDC11Code": "63868-0819-12",
      "ProductNDC": "63868-819",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Fexofenadine Hydrochloride 60 Mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210517",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076502",
      "LabelerName": "Chain Drug Marketing Association INC",
      "SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210517",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "69097-819-12",
      "PackageDescription": "500 TABLET in 1 BOTTLE (69097-819-12) ",
      "NDC11Code": "69097-0819-12",
      "ProductNDC": "69097-819",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160722",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079162",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-05-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160722",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial- onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
      "Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch (maize), sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and, opadry pink (titanium dioxide, hypromellose 6cp, PEG 400,iron oxide red) for 200 mg tablets."
    },
    {
      "NDCCode": "69842-929-12",
      "PackageDescription": "1 KIT in 1 CARTON (69842-929-12)  *  1 BOTTLE in 1 CARTON (69842-699-26)  / 118 mL in 1 BOTTLE *  1 BOTTLE in 1 CARTON (69842-819-26)  / 118 mL in 1 BOTTLE",
      "NDC11Code": "69842-0929-12",
      "ProductNDC": "69842-929",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tussin Dm Max Daytime Nighttime",
      "NonProprietaryName": "Dextromethorphan Hbr, Doxylamine Succinate, Guaifesesin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20180720",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "CVS Pharmacy",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180720",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "74000-819-12",
      "PackageDescription": ".354882 L in 1 BOTTLE (74000-819-12) ",
      "NDC11Code": "74000-0819-12",
      "ProductNDC": "74000-819",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Yellowhammer Brewing Hand Sanitizer",
      "NonProprietaryName": "Ethanol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200325",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Yellowhammer Brewing, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "80",
      "StrengthUnit": "L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200325",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "58160-726-15",
      "PackageDescription": "1 KIT in 1 CARTON (58160-726-15)  *  .5 mL in 1 VIAL (58160-816-03)  *  .85 mL in 1 SYRINGE (58160-817-02) ",
      "NDC11Code": "58160-0726-15",
      "ProductNDC": "58160-726",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Hiberix",
      "NonProprietaryName": "Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231220",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125347",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "Status": "Active",
      "LastUpdate": "2026-09-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231220",
      "SamplePackage": "N",
      "IndicationAndUsage": "HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae (H. influenzae) type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).",
      "Description": "HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] is a solution for intramuscular injection, supplied as a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent. HIBERIX contains Haemophilus b capsular polysaccharide (polyribosyl‑ribitol‑phosphate [PRP]), a high molecular weight polymer prepared from the H. influenzae type b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification. The tetanus toxin, prepared from Clostridium tetani grown in a semi‑synthetic medium, is detoxified with formaldehyde and purified. The capsular polysaccharide is covalently bound to the tetanus toxoid. After purification, the conjugate is lyophilized in the presence of lactose as a stabilizer. The diluent for HIBERIX is a sterile saline solution (0.9% sodium chloride) supplied in prefilled syringes. After reconstitution, each approximately 0.5‑mL dose of HIBERIX contains 10 mcg of purified capsular polysaccharide conjugated to approximately 25 mcg of tetanus toxoid, 12.6 mg of lactose, and ≤0.5 mcg of residual formaldehyde. HIBERIX does not contain a preservative. The stopper of the vial containing Lyophilized Antigen Component and the tip cap and rubber plunger stopper of the prefilled syringe containing Sterile Saline Diluent are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-740-21",
      "PackageDescription": "10 APPLICATOR in 1 CARTON (58160-740-21)  / 1.5 mL in 1 APPLICATOR (58160-740-02) ",
      "NDC11Code": "58160-0740-21",
      "ProductNDC": "58160-740",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Rotarix",
      "NonProprietaryName": "Rotavirus Vaccine, Live, Oral",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230201",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125265",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN",
      "StrengthNumber": "1000",
      "StrengthUnit": "[CCID_50]/mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Live Attenuated Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Vaccines, Attenuated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230201",
      "SamplePackage": "N",
      "IndicationAndUsage": "ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.",
      "Description": "ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus vaccine strain is propagated on Vero cells. There are two formulations of ROTARIX: a reconstituted lyophilized formulation (supplied in a vial and oral dosing applicator presentation) and a liquid formulation (supplied in an oral dosing applicator only presentation). Formulation for the Vial and Oral Dosing Applicator Presentation. After reconstitution of the lyophilized vaccine component, each 1 mL dose of the ROTARIX formulation for the vial and oral dosing applicator presentation contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The lyophilized vaccine component of this ROTARIX formulation contains amino acids, dextran, Dulbecco’s Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in this ROTARIX formulation. PCV-1 is not known to cause disease in humans. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral dosing applicator of liquid diluent [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex; the vial stoppers are not made with natural rubber latex. This ROTARIX formulation contains no preservatives. Formulation for the Oral Dosing Applicator Only Presentation. Each 1.5 mL dose of the ROTARIX formulation for the oral dosing applicator only presentation contains at least 106.0 CCID50 of live, attenuated rotavirus. This ROTARIX formulation contains disodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sucrose, and sterile water. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. This ROTARIX formulation contains an antacid component (disodium adipate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose prefilled oral dosing applicator [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex. This ROTARIX formulation contains no preservatives."
    },
    {
      "NDCCode": "58160-806-05",
      "PackageDescription": "10 VIAL in 1 CARTON (58160-806-05)  > .5 mL in 1 VIAL (58160-806-01)",
      "NDC11Code": "58160-0806-05",
      "ProductNDC": "58160-806",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Hiberix",
      "NonProprietaryName": "Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20090824",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125347",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN",
      "StrengthNumber": "10",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Inactivated Haemophilus Influenzae B Vaccine [EPC],Actively Acquired Immunity [PE],Haemophilus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "58160-809-05",
      "PackageDescription": "10 VIAL in 1 CARTON (58160-809-05)  > .5 mL in 1 VIAL (58160-809-01)",
      "NDC11Code": "58160-0809-05",
      "ProductNDC": "58160-809",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Menhibrix",
      "NonProprietaryName": "Meningococcal Groups C And Y And Haemophilus B Tetanus Toxoid Conjugate Vaccine",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130903",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125363",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE ANTIGEN; NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE ANTIGEN; HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN",
      "StrengthNumber": "5; 5; 2.5",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Pharm_Classes": "Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Haemophilus Influenzae B Vaccine [EPC],Actively Acquired Immunity [PE],Haemophilus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "58160-810-11",
      "PackageDescription": "10 VIAL in 1 CARTON (58160-810-11)  > .5 mL in 1 VIAL (58160-810-01) ",
      "NDC11Code": "58160-0810-11",
      "ProductNDC": "58160-810",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Infanrix",
      "NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20090724",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103647",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "25; 8; 25; 10; 25",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20090724",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58160-815-11",
      "PackageDescription": "10 VIAL in 1 CARTON (58160-815-11)  > 1 mL in 1 VIAL (58160-815-01)",
      "NDC11Code": "58160-0815-11",
      "ProductNDC": "58160-815",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Twinrix",
      "NonProprietaryName": "Hepatitis A And Hepatitis B (recombinant) Vaccine",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20070607",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103850",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "720; 20",
      "StrengthUnit": "[iU]/mL; ug/mL",
      "Pharm_Classes": "Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-12",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "58160-815-34",
      "PackageDescription": "1 SYRINGE in 1 CARTON (58160-815-34)  > 1 mL in 1 SYRINGE (58160-815-05)",
      "NDC11Code": "58160-0815-34",
      "ProductNDC": "58160-815",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Twinrix",
      "NonProprietaryName": "Hepatitis A And Hepatitis B (recombinant) Vaccine",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20070607",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103850",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "720; 20",
      "StrengthUnit": "[iU]/mL; ug/mL",
      "Pharm_Classes": "Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-12",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "58160-818-11",
      "PackageDescription": "1 KIT in 1 CARTON (58160-818-11)  *  10 VIAL in 1 CARTON (58160-816-05)  / .5 mL in 1 VIAL (58160-816-01)  *  10 VIAL in 1 PACKAGE (58160-817-05)  / .85 mL in 1 VIAL (58160-817-01) ",
      "NDC11Code": "58160-0818-11",
      "ProductNDC": "58160-818",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Hiberix",
      "NonProprietaryName": "Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20151221",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125347",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "Status": "Active",
      "LastUpdate": "2026-09-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20151221",
      "SamplePackage": "N",
      "IndicationAndUsage": "HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae (H. influenzae) type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).",
      "Description": "HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] is a solution for intramuscular injection, supplied as a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent. HIBERIX contains Haemophilus b capsular polysaccharide (polyribosyl‑ribitol‑phosphate [PRP]), a high molecular weight polymer prepared from the H. influenzae type b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification. The tetanus toxin, prepared from Clostridium tetani grown in a semi‑synthetic medium, is detoxified with formaldehyde and purified. The capsular polysaccharide is covalently bound to the tetanus toxoid. After purification, the conjugate is lyophilized in the presence of lactose as a stabilizer. The diluent for HIBERIX is a sterile saline solution (0.9% sodium chloride) supplied in prefilled syringes. After reconstitution, each approximately 0.5‑mL dose of HIBERIX contains 10 mcg of purified capsular polysaccharide conjugated to approximately 25 mcg of tetanus toxoid, 12.6 mg of lactose, and ≤0.5 mcg of residual formaldehyde. HIBERIX does not contain a preservative. The stopper of the vial containing Lyophilized Antigen Component and the tip cap and rubber plunger stopper of the prefilled syringe containing Sterile Saline Diluent are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-820-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-820-52)  / .5 mL in 1 SYRINGE (58160-820-43) ",
      "NDC11Code": "58160-0820-52",
      "ProductNDC": "58160-820",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Engerix-b",
      "NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20070425",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103239",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "10",
      "StrengthUnit": "ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070425",
      "SamplePackage": "N",
      "IndicationAndUsage": "ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.",
      "Description": "ENGERIX‑B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX‑B result in a product that contains no more than 5% yeast protein. Each 0.5 mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1 mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX‑B contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL). ENGERIX‑B is available in vials (adult dose only) and prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. ENGERIX‑B is formulated without preservatives."
    },
    {
      "NDCCode": "58160-821-11",
      "PackageDescription": "10 VIAL in 1 CARTON (58160-821-11)  / 1 mL in 1 VIAL (58160-821-01) ",
      "NDC11Code": "58160-0821-11",
      "ProductNDC": "58160-821",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Engerix-b",
      "NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20070328",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103239",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "20",
      "StrengthUnit": "ug/mL",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070328",
      "SamplePackage": "N",
      "IndicationAndUsage": "ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.",
      "Description": "ENGERIX‑B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX‑B result in a product that contains no more than 5% yeast protein. Each 0.5 mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1 mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX‑B contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL). ENGERIX‑B is available in vials (adult dose only) and prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. ENGERIX‑B is formulated without preservatives."
    },
    {
      "NDCCode": "58160-821-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-821-52)  / 1 mL in 1 SYRINGE (58160-821-43) ",
      "NDC11Code": "58160-0821-52",
      "ProductNDC": "58160-821",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Engerix-b",
      "NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20070328",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103239",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "20",
      "StrengthUnit": "ug/mL",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070328",
      "SamplePackage": "N",
      "IndicationAndUsage": "ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.",
      "Description": "ENGERIX‑B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX‑B result in a product that contains no more than 5% yeast protein. Each 0.5 mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1 mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX‑B contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL). ENGERIX‑B is available in vials (adult dose only) and prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. ENGERIX‑B is formulated without preservatives."
    },
    {
      "NDCCode": "58160-824-15",
      "PackageDescription": "1 KIT in 1 CARTON (58160-824-15)  *  .5 mL in 1 VIAL (58160-831-03)  *  .5 mL in 1 SYRINGE (58160-833-02) ",
      "NDC11Code": "58160-0824-15",
      "ProductNDC": "58160-824",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Priorix",
      "NonProprietaryName": "Measels, Mumps, And Rubella Vaccine, Live",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20220603",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125748",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "Status": "Active",
      "LastUpdate": "2026-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220603",
      "SamplePackage": "N",
      "IndicationAndUsage": "PRIORIX is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.",
      "Description": "PRIORIX (Measles, Mumps, and Rubella Vaccine, Live) is an injectable suspension for subcutaneous use. PRIORIX is supplied as a sterile, Lyophilized Antigen Component, Live which is reconstituted at the time of use with the accompanying Sterile Water Diluent Component. The Lyophilized Antigen Component, Live is a whitish to slightly pink powder, a portion of which may be yellowish to slightly orange. PRIORIX contains the Schwarz strain of live attenuated measles virus, the RIT 4385 strain of live attenuated mumps virus (derived from the Jeryl Lynn strain), both propagated in chick‑embryo fibroblasts from embryonated eggs of specific pathogen-free flocks and the Wistar RA 27/3 strain of live attenuated rubella virus propagated in MRC-5 human diploid cells. The 3 virus strains are cultured in media containing amino acids, a small amount of neomycin sulfate and bovine serum albumin and are stabilized after multiple washing steps in media free from antibiotics and albumin. The attenuated measles, mumps and rubella viruses are then mixed with a stabilizer prior to lyophilization. After reconstitution, each approximately 0.5-mL dose contains not less than 3.4 log10 Cell Culture Infective Dose 50% (CCID50) of measles virus, 4.2 log10 CCID50 of mumps virus, and 3.3 log10 CCID50 of rubella virus. Each dose also contains 32 mg of anhydrous lactose, 9 mg of sorbitol, 9 mg of amino acids, and 8 mg of mannitol. Each dose may also contain residual amounts of neomycin sulphate (≤25 mcg), ovalbumin (≤60 ng), and bovine serum albumin (≤50 ng), from the manufacturing process. After reconstitution, PRIORIX is a clear peach- to fuchsia pink-colored suspension. PRIORIX contains no preservative. The tip caps of the prefilled syringes of Sterile Water Diluent Component contain natural rubber latex. The plungers of the syringes and the stoppers of the Lyophilized Antigen Component, Live vials are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-830-34",
      "PackageDescription": "1 SYRINGE in 1 CARTON (58160-830-34)  > .5 mL in 1 SYRINGE (58160-830-05)",
      "NDC11Code": "58160-0830-34",
      "ProductNDC": "58160-830",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Cervarix",
      "NonProprietaryName": "Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20091016",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125259",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN",
      "StrengthNumber": "20; 20",
      "StrengthUnit": "ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "58160-830-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-830-52)  > .5 mL in 1 SYRINGE (58160-830-43)",
      "NDC11Code": "58160-0830-52",
      "ProductNDC": "58160-830",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Cervarix",
      "NonProprietaryName": "Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20091016",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125259",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN",
      "StrengthNumber": "20; 20",
      "StrengthUnit": "ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "58160-854-52",
      "PackageDescription": "1 KIT in 1 CARTON (58160-854-52)  *  10 VIAL in 1 CARTON (58160-851-10)  / 1 mL in 1 VIAL (58160-851-01)  *  1 mL in 1 APPLICATOR (58160-853-02) ",
      "NDC11Code": "58160-0854-52",
      "ProductNDC": "58160-854",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Rotarix",
      "NonProprietaryName": "Rotavirus Vaccine, Live, Oral",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20110113",
      "EndMarketingDate": "20250224",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125265",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110113",
      "EndMarketingDatePackage": "20250224",
      "SamplePackage": "N",
      "IndicationAndUsage": "ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.",
      "Description": "ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus vaccine strain is propagated on Vero cells. There are two formulations of ROTARIX: a reconstituted lyophilized formulation (supplied in a vial and oral dosing applicator presentation) and a liquid formulation (supplied in an oral dosing applicator only presentation). Formulation for the Vial and Oral Dosing Applicator Presentation. After reconstitution of the lyophilized vaccine component, each 1 mL dose of the ROTARIX formulation for the vial and oral dosing applicator presentation contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The lyophilized vaccine component of this ROTARIX formulation contains amino acids, dextran, Dulbecco’s Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in this ROTARIX formulation. PCV-1 is not known to cause disease in humans. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral dosing applicator of liquid diluent [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex; the vial stoppers are not made with natural rubber latex. This ROTARIX formulation contains no preservatives. Formulation for the Oral Dosing Applicator Only Presentation. Each 1.5 mL dose of the ROTARIX formulation for the oral dosing applicator only presentation contains at least 106.0 CCID50 of live, attenuated rotavirus. This ROTARIX formulation contains disodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sucrose, and sterile water. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. This ROTARIX formulation contains an antacid component (disodium adipate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose prefilled oral dosing applicator [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex. This ROTARIX formulation contains no preservatives."
    },
    {
      "NDCCode": "58160-903-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-903-52)  > .5 mL in 1 SYRINGE (58160-903-41)",
      "NDC11Code": "58160-0903-52",
      "ProductNDC": "58160-903",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2015/2016",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20150701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "58160-976-20",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-976-20)  / .5 mL in 1 SYRINGE (58160-976-02) ",
      "NDC11Code": "58160-0976-20",
      "ProductNDC": "58160-976",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Bexsero",
      "NonProprietaryName": "Neisseria Meningitidis Serogroup B Nhba Fusion Protein Antigen, Neisseria Meningitidis Serogroup B Fhbp Fusion Protein Antigen And Neisseria Meningitidis Serogroup B Nada Protein Antigen",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20161201",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125546",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN",
      "StrengthNumber": "50; 50; 50; 25",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2025-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161201",
      "SamplePackage": "N",
      "IndicationAndUsage": "BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals aged 10 through 25 years.",
      "Description": "BEXSERO (Meningococcal Group B Vaccine) is a sterile, white, opalescent, injectable suspension for intramuscular use. Each 0.5-mL dose of BEXSERO is formulated to contain 50 mcg each of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), and 25 mcg of Outer Membrane Vesicles (OMV), 1.5 mg aluminum hydroxide (0.519 mg of Al3+), 3.125 mg sodium chloride, 0.776 mg histidine, and 10 mg sucrose at pH 6.4 to 6.7. The NadA component is a fragment of the full-length protein derived from N. meningitidis strain 2996 (peptide 8 variant 2/3)1. The NHBA component is a recombinant fusion protein comprised of NHBA (peptide 2)1 and accessory protein 953 derived from N. meningitidis strains NZ98/254 and 2996, respectively. The fHbp component is a recombinant fusion protein comprised of fHbp (variant 1.1)1 and the accessory protein 936 derived from N. meningitidis strains MC58 and 2996, respectively. These 3 recombinant proteins are individually produced in Escherichia coli and purified through a series of column chromatography steps. The OMV antigenic component is produced by fermentation of N. meningitidis strain NZ98/254 (expressing outer membrane protein Porin A [PorA] serosubtype P1.4)2, followed by inactivation of the bacteria by deoxycholate, which also mediates vesicle formation. The antigens are adsorbed onto aluminum hydroxide. Each dose contains less than 0.01 mcg kanamycin (by calculation). The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex."
    },
    {
      "NDCCode": "10237-819-60",
      "PackageDescription": "170 g in 1 CAN (10237-819-60)",
      "NDC11Code": "10237-0819-60",
      "ProductNDC": "10237-819",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arrid Extra Extra Dry Xx",
      "ProprietaryNameSuffix": "Ultra Clear Ultra Clean",
      "NonProprietaryName": "Aluminum Chlorohydrate",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110422",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALUMINUM CHLOROHYDRATE",
      "StrengthNumber": "246",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "11673-819-08",
      "PackageDescription": "80 TABLET in 1 BOTTLE (11673-819-08) ",
      "NDC11Code": "11673-0819-08",
      "ProductNDC": "11673-819",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Naproxen Sodium And Diphenhydramine Hcl",
      "NonProprietaryName": "Naproxen Sodium And Diphenhydramine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213663",
      "LabelerName": "TARGET CORPORATION",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM",
      "StrengthNumber": "25; 220",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240301",
      "SamplePackage": "N",
      "IndicationAndUsage": " for relief of occasional sleeplessness when associated with minor aches and pains  helps you fall asleep and stay asleep."
    },
    {
      "NDCCode": "16714-819-01",
      "PackageDescription": "10 CAPSULE in 1 CARTON (16714-819-01) ",
      "NDC11Code": "16714-0819-01",
      "ProductNDC": "16714-819",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oseltamivir Phosphate",
      "NonProprietaryName": "Oseltamivir Phosphate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180903",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209438",
      "LabelerName": "NorthStar RxLLC",
      "SubstanceName": "OSELTAMIVIR PHOSPHATE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180903",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oseltamivir phosphate  is an influenza neuraminidase inhibitor (NAI) indicated for:  Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)  Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use:   Not a substitute for annual influenza vaccination. (1.3)  Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3)  Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
      "Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as:  Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch.  Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:."
    }
  ]
}
                    

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<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>58160-819-12</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (58160-819-12)  *  .5 mL in 1 VIAL (58160-828-01)  *  .5 mL in 1 VIAL (58160-829-01) </PackageDescription>
    <NDC11Code>58160-0819-12</NDC11Code>
    <ProductNDC>58160-819</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Shingrix</ProprietaryName>
    <NonProprietaryName>Zoster Vaccine Recombinant, Adjuvanted</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20171020</StartMarketingDate>
    <EndMarketingDate>20250823</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125614</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20171020</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250823</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles): 1 in adults aged 50 years and older., 2 in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.</IndicationAndUsage>
    <Description>SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) is a sterile injectable suspension for intramuscular use that contains recombinant varicella zoster virus gE antigen adjuvanted with AS01B. The vial and vial presentation is supplied as a vial of lyophilized recombinant varicella zoster virus surface gE antigen component (Lyophilized gE Antigen Component), which must be reconstituted at the time of use with the accompanying vial of AS01B (Adjuvant Suspension Component) to form SHINGRIX. The SHINGRIX prefilled syringe presentation does not require reconstitution. SHINGRIX is a sterile, opalescent, colorless to pale brownish liquid. The gE antigen is obtained by culturing genetically engineered Chinese Hamster Ovary cells, which carry a truncated gE gene, in media containing amino acids, with no albumin, antibiotics, or animal‑derived proteins. The gE protein is purified by several chromatographic steps and formulated with excipients. The AS01B adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) derived from Salmonella minnesota and QS‑21, a saponin purified from Quillaja saponaria Molina plant extract, and is combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. Each 0.5‑mL dose is formulated to contain 50 mcg of the recombinant gE antigen, 50 mcg of MPL, and 50 mcg of QS‑21. Each dose also contains 20 mg of sucrose, 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. SHINGRIX does not contain preservatives. Each dose may also contain residual amounts of host cell proteins (≤3.0%) and DNA (≤2.1 picograms) from the manufacturing process. In the vial and vial presentation, the vial stoppers are not made with natural rubber latex. In the prefilled syringe presentation, the tip cap and rubber plunger stopper are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-882-12</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (58160-882-12)  *  .5 mL in 1 VIAL (58160-719-03)  *  .5 mL in 1 SYRINGE (58160-749-07) </PackageDescription>
    <NDC11Code>58160-0882-12</NDC11Code>
    <ProductNDC>58160-882</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Arexvy</ProprietaryName>
    <NonProprietaryName>Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20260430</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125775</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: 1 individuals 60 years of age and older;, 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
    <Description>AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre‑fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial or prefilled syringe of AS01E adjuvant as the Adjuvant Suspension Component. The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal‑derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. The AS01E adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS‑21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution of the vial and vial presentation, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. After reconstitution of the vial and prefilled syringe presentation, each dose (approximately 0.5 mL) is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 16.3 mg of Trehalose, 4.4 mg of sodium chloride, 0.87 mg of potassium dihydrogen phosphate, 0.29 mg of dipotassium phosphate, 0.20 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY contains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process. The stopper of the vial containing Lyophilized Antigen Component or Adjuvant Suspension Component and the tip cap and plunger stopper of the prefilled syringe containing Adjuvant Suspension Component are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-964-12</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (58160-964-12)  *  1 mL in 1 VIAL, GLASS (58160-966-01)  *  1 mL in 1 SYRINGE (58160-967-02) </PackageDescription>
    <NDC11Code>58160-0964-12</NDC11Code>
    <ProductNDC>58160-964</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Rabavert</ProprietaryName>
    <NonProprietaryName>Rabies Vaccine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20161219</StartMarketingDate>
    <EndMarketingDate>20240131</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103334</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20161219</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. Usually an immunization series is initiated and completed with 1 vaccine product. No clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. However, for booster immunization, RabAvert was shown to elicit protective antibody level responses in persons tested who received a primary series with HDCV.4,11.</IndicationAndUsage>
    <Description>RabAvert Rabies Vaccine produced by GlaxoSmithKline GmbH is a sterile, freeze-dried vaccine obtained by growing the fixed-virus strain Flury Low Egg Passage (LEP) in primary cultures of chicken fibroblasts. The strain Flury LEP was obtained from American Type Culture Collection as the 59th egg passage. The growth medium for propagation of the virus is a synthetic cell culture medium with the addition of human albumin, polygeline (processed bovine gelatin), and antibiotics. The virus is inactivated with β-propiolactone and further processed by zonal centrifugation in a sucrose density gradient. The vaccine is lyophilized after addition of a stabilizer solution that consists of buffered polygeline and potassium glutamate. One dose of reconstituted vaccine contains ≤12 mg polygeline (processed bovine gelatin), ≤0.3 mg human serum albumin, 1 mg potassium glutamate, and 0.3 mg sodium EDTA. Small quantities of bovine serum are used in the cell culture process. Bovine components originate only from the United States, Australia, and New Zealand. Minimal amounts of chicken protein may be present in the final product; ovalbumin content is ≤3 ng/dose (1 mL), based on ELISA. Antibiotics (neomycin, chlortetracycline, amphotericin B) added during cell and virus propagation are largely removed during subsequent steps in the manufacturing process. In the final vaccine, neomycin is present at ≤10 mcg, chlortetracycline at ≤200 ng, and amphotericin B at ≤20 ng per dose. RabAvert is intended for intramuscular (IM) injection. The vaccine contains no preservative and should be used immediately after reconstitution with the supplied Sterile Diluent for RabAvert (Water for Injection). The potency of the final product is determined by the National Institutes of Health (NIH) mouse potency test using the United States (US) reference standard. The potency of 1 dose (1.0 mL) of RabAvert is at least 2.5 IU of rabies antigen. RabAvert is a white, freeze-dried vaccine for reconstitution with the diluent prior to use; the reconstituted vaccine is a clear to slightly opalescent, colorless to slightly pink suspension.</Description>
  </NDC>
  <NDC>
    <NDCCode>30142-819-12</NDCCode>
    <PackageDescription>236 mL in 1 TUBE (30142-819-12) </PackageDescription>
    <NDC11Code>30142-0819-12</NDC11Code>
    <ProductNDC>30142-819</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Simple Truth Mineral Based Spf 50 Sunscreen</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180920</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>THE KROGER COMPANY</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>30; 150</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>37000-819-12</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (37000-819-12)  &gt; 164 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0819-12</NDC11Code>
    <ProductNDC>37000-819</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest Complete Multi-benefit</ProprietaryName>
    <ProprietaryNameSuffix>Whitening Plus Deep Clean</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20110701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-27</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>59779-819-58</NDCCode>
    <PackageDescription>12 CAN in 1 CASE (59779-819-58)  &gt; 121.6 g in 1 CAN (59779-819-57)</PackageDescription>
    <NDC11Code>59779-0819-58</NDC11Code>
    <ProductNDC>59779-819</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sensitive Tooth Paste</ProprietaryName>
    <ProprietaryNameSuffix>Multi Action</ProprietaryNameSuffix>
    <NonProprietaryName>Fluoride</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20111213</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>5; .15</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63868-819-12</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (63868-819-12)  / 6 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63868-0819-12</NDC11Code>
    <ProductNDC>63868-819</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Fexofenadine Hydrochloride 60 Mg</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210517</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076502</ApplicationNumber>
    <LabelerName>Chain Drug Marketing Association INC</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69097-819-12</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (69097-819-12) </PackageDescription>
    <NDC11Code>69097-0819-12</NDC11Code>
    <ProductNDC>69097-819</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160722</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079162</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial- onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch (maize), sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and, opadry pink (titanium dioxide, hypromellose 6cp, PEG 400,iron oxide red) for 200 mg tablets.</Description>
  </NDC>
  <NDC>
    <NDCCode>69842-929-12</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (69842-929-12)  *  1 BOTTLE in 1 CARTON (69842-699-26)  / 118 mL in 1 BOTTLE *  1 BOTTLE in 1 CARTON (69842-819-26)  / 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69842-0929-12</NDC11Code>
    <ProductNDC>69842-929</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tussin Dm Max Daytime Nighttime</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr, Doxylamine Succinate, Guaifesesin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20180720</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>74000-819-12</NDCCode>
    <PackageDescription>.354882 L in 1 BOTTLE (74000-819-12) </PackageDescription>
    <NDC11Code>74000-0819-12</NDC11Code>
    <ProductNDC>74000-819</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Yellowhammer Brewing Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethanol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200325</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Yellowhammer Brewing, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200325</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58160-726-15</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (58160-726-15)  *  .5 mL in 1 VIAL (58160-816-03)  *  .85 mL in 1 SYRINGE (58160-817-02) </PackageDescription>
    <NDC11Code>58160-0726-15</NDC11Code>
    <ProductNDC>58160-726</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Hiberix</ProprietaryName>
    <NonProprietaryName>Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231220</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125347</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae (H. influenzae) type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).</IndicationAndUsage>
    <Description>HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] is a solution for intramuscular injection, supplied as a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent. HIBERIX contains Haemophilus b capsular polysaccharide (polyribosyl‑ribitol‑phosphate [PRP]), a high molecular weight polymer prepared from the H. influenzae type b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification. The tetanus toxin, prepared from Clostridium tetani grown in a semi‑synthetic medium, is detoxified with formaldehyde and purified. The capsular polysaccharide is covalently bound to the tetanus toxoid. After purification, the conjugate is lyophilized in the presence of lactose as a stabilizer. The diluent for HIBERIX is a sterile saline solution (0.9% sodium chloride) supplied in prefilled syringes. After reconstitution, each approximately 0.5‑mL dose of HIBERIX contains 10 mcg of purified capsular polysaccharide conjugated to approximately 25 mcg of tetanus toxoid, 12.6 mg of lactose, and ≤0.5 mcg of residual formaldehyde. HIBERIX does not contain a preservative. The stopper of the vial containing Lyophilized Antigen Component and the tip cap and rubber plunger stopper of the prefilled syringe containing Sterile Saline Diluent are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-740-21</NDCCode>
    <PackageDescription>10 APPLICATOR in 1 CARTON (58160-740-21)  / 1.5 mL in 1 APPLICATOR (58160-740-02) </PackageDescription>
    <NDC11Code>58160-0740-21</NDC11Code>
    <ProductNDC>58160-740</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Rotarix</ProprietaryName>
    <NonProprietaryName>Rotavirus Vaccine, Live, Oral</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230201</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125265</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>[CCID_50]/mL</StrengthUnit>
    <Pharm_Classes>Actively Acquired Immunity [PE], Live Attenuated Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Vaccines, Attenuated [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.</IndicationAndUsage>
    <Description>ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus vaccine strain is propagated on Vero cells. There are two formulations of ROTARIX: a reconstituted lyophilized formulation (supplied in a vial and oral dosing applicator presentation) and a liquid formulation (supplied in an oral dosing applicator only presentation). Formulation for the Vial and Oral Dosing Applicator Presentation. After reconstitution of the lyophilized vaccine component, each 1 mL dose of the ROTARIX formulation for the vial and oral dosing applicator presentation contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The lyophilized vaccine component of this ROTARIX formulation contains amino acids, dextran, Dulbecco’s Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in this ROTARIX formulation. PCV-1 is not known to cause disease in humans. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral dosing applicator of liquid diluent [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex; the vial stoppers are not made with natural rubber latex. This ROTARIX formulation contains no preservatives. Formulation for the Oral Dosing Applicator Only Presentation. Each 1.5 mL dose of the ROTARIX formulation for the oral dosing applicator only presentation contains at least 106.0 CCID50 of live, attenuated rotavirus. This ROTARIX formulation contains disodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sucrose, and sterile water. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. This ROTARIX formulation contains an antacid component (disodium adipate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose prefilled oral dosing applicator [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex. This ROTARIX formulation contains no preservatives.</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-806-05</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (58160-806-05)  &gt; .5 mL in 1 VIAL (58160-806-01)</PackageDescription>
    <NDC11Code>58160-0806-05</NDC11Code>
    <ProductNDC>58160-806</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Hiberix</ProprietaryName>
    <NonProprietaryName>Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20090824</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125347</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Inactivated Haemophilus Influenzae B Vaccine [EPC],Actively Acquired Immunity [PE],Haemophilus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58160-809-05</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (58160-809-05)  &gt; .5 mL in 1 VIAL (58160-809-01)</PackageDescription>
    <NDC11Code>58160-0809-05</NDC11Code>
    <ProductNDC>58160-809</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Menhibrix</ProprietaryName>
    <NonProprietaryName>Meningococcal Groups C And Y And Haemophilus B Tetanus Toxoid Conjugate Vaccine</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20130903</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125363</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE ANTIGEN; NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE ANTIGEN; HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN</SubstanceName>
    <StrengthNumber>5; 5; 2.5</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Pharm_Classes>Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Haemophilus Influenzae B Vaccine [EPC],Actively Acquired Immunity [PE],Haemophilus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58160-810-11</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (58160-810-11)  &gt; .5 mL in 1 VIAL (58160-810-01) </PackageDescription>
    <NDC11Code>58160-0810-11</NDC11Code>
    <ProductNDC>58160-810</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Infanrix</ProprietaryName>
    <NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20090724</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103647</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>25; 8; 25; 10; 25</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL</StrengthUnit>
    <Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>58160-815-11</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (58160-815-11)  &gt; 1 mL in 1 VIAL (58160-815-01)</PackageDescription>
    <NDC11Code>58160-0815-11</NDC11Code>
    <ProductNDC>58160-815</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Twinrix</ProprietaryName>
    <NonProprietaryName>Hepatitis A And Hepatitis B (recombinant) Vaccine</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103850</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
    <StrengthNumber>720; 20</StrengthNumber>
    <StrengthUnit>[iU]/mL; ug/mL</StrengthUnit>
    <Pharm_Classes>Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-12</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58160-815-34</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (58160-815-34)  &gt; 1 mL in 1 SYRINGE (58160-815-05)</PackageDescription>
    <NDC11Code>58160-0815-34</NDC11Code>
    <ProductNDC>58160-815</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Twinrix</ProprietaryName>
    <NonProprietaryName>Hepatitis A And Hepatitis B (recombinant) Vaccine</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103850</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
    <StrengthNumber>720; 20</StrengthNumber>
    <StrengthUnit>[iU]/mL; ug/mL</StrengthUnit>
    <Pharm_Classes>Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-12</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58160-818-11</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (58160-818-11)  *  10 VIAL in 1 CARTON (58160-816-05)  / .5 mL in 1 VIAL (58160-816-01)  *  10 VIAL in 1 PACKAGE (58160-817-05)  / .85 mL in 1 VIAL (58160-817-01) </PackageDescription>
    <NDC11Code>58160-0818-11</NDC11Code>
    <ProductNDC>58160-818</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Hiberix</ProprietaryName>
    <NonProprietaryName>Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20151221</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125347</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae (H. influenzae) type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).</IndicationAndUsage>
    <Description>HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] is a solution for intramuscular injection, supplied as a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent. HIBERIX contains Haemophilus b capsular polysaccharide (polyribosyl‑ribitol‑phosphate [PRP]), a high molecular weight polymer prepared from the H. influenzae type b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification. The tetanus toxin, prepared from Clostridium tetani grown in a semi‑synthetic medium, is detoxified with formaldehyde and purified. The capsular polysaccharide is covalently bound to the tetanus toxoid. After purification, the conjugate is lyophilized in the presence of lactose as a stabilizer. The diluent for HIBERIX is a sterile saline solution (0.9% sodium chloride) supplied in prefilled syringes. After reconstitution, each approximately 0.5‑mL dose of HIBERIX contains 10 mcg of purified capsular polysaccharide conjugated to approximately 25 mcg of tetanus toxoid, 12.6 mg of lactose, and ≤0.5 mcg of residual formaldehyde. HIBERIX does not contain a preservative. The stopper of the vial containing Lyophilized Antigen Component and the tip cap and rubber plunger stopper of the prefilled syringe containing Sterile Saline Diluent are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-820-52</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (58160-820-52)  / .5 mL in 1 SYRINGE (58160-820-43) </PackageDescription>
    <NDC11Code>58160-0820-52</NDC11Code>
    <ProductNDC>58160-820</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Engerix-b</ProprietaryName>
    <NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070425</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103239</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070425</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.</IndicationAndUsage>
    <Description>ENGERIX‑B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX‑B result in a product that contains no more than 5% yeast protein. Each 0.5 mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1 mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX‑B contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL). ENGERIX‑B is available in vials (adult dose only) and prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. ENGERIX‑B is formulated without preservatives.</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-821-11</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (58160-821-11)  / 1 mL in 1 VIAL (58160-821-01) </PackageDescription>
    <NDC11Code>58160-0821-11</NDC11Code>
    <ProductNDC>58160-821</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Engerix-b</ProprietaryName>
    <NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070328</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103239</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.</IndicationAndUsage>
    <Description>ENGERIX‑B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX‑B result in a product that contains no more than 5% yeast protein. Each 0.5 mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1 mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX‑B contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL). ENGERIX‑B is available in vials (adult dose only) and prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. ENGERIX‑B is formulated without preservatives.</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-821-52</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (58160-821-52)  / 1 mL in 1 SYRINGE (58160-821-43) </PackageDescription>
    <NDC11Code>58160-0821-52</NDC11Code>
    <ProductNDC>58160-821</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Engerix-b</ProprietaryName>
    <NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20070328</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103239</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.</IndicationAndUsage>
    <Description>ENGERIX‑B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX‑B result in a product that contains no more than 5% yeast protein. Each 0.5 mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1 mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX‑B contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL). ENGERIX‑B is available in vials (adult dose only) and prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. ENGERIX‑B is formulated without preservatives.</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-824-15</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (58160-824-15)  *  .5 mL in 1 VIAL (58160-831-03)  *  .5 mL in 1 SYRINGE (58160-833-02) </PackageDescription>
    <NDC11Code>58160-0824-15</NDC11Code>
    <ProductNDC>58160-824</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Priorix</ProprietaryName>
    <NonProprietaryName>Measels, Mumps, And Rubella Vaccine, Live</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20220603</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125748</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PRIORIX is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.</IndicationAndUsage>
    <Description>PRIORIX (Measles, Mumps, and Rubella Vaccine, Live) is an injectable suspension for subcutaneous use. PRIORIX is supplied as a sterile, Lyophilized Antigen Component, Live which is reconstituted at the time of use with the accompanying Sterile Water Diluent Component. The Lyophilized Antigen Component, Live is a whitish to slightly pink powder, a portion of which may be yellowish to slightly orange. PRIORIX contains the Schwarz strain of live attenuated measles virus, the RIT 4385 strain of live attenuated mumps virus (derived from the Jeryl Lynn strain), both propagated in chick‑embryo fibroblasts from embryonated eggs of specific pathogen-free flocks and the Wistar RA 27/3 strain of live attenuated rubella virus propagated in MRC-5 human diploid cells. The 3 virus strains are cultured in media containing amino acids, a small amount of neomycin sulfate and bovine serum albumin and are stabilized after multiple washing steps in media free from antibiotics and albumin. The attenuated measles, mumps and rubella viruses are then mixed with a stabilizer prior to lyophilization. After reconstitution, each approximately 0.5-mL dose contains not less than 3.4 log10 Cell Culture Infective Dose 50% (CCID50) of measles virus, 4.2 log10 CCID50 of mumps virus, and 3.3 log10 CCID50 of rubella virus. Each dose also contains 32 mg of anhydrous lactose, 9 mg of sorbitol, 9 mg of amino acids, and 8 mg of mannitol. Each dose may also contain residual amounts of neomycin sulphate (≤25 mcg), ovalbumin (≤60 ng), and bovine serum albumin (≤50 ng), from the manufacturing process. After reconstitution, PRIORIX is a clear peach- to fuchsia pink-colored suspension. PRIORIX contains no preservative. The tip caps of the prefilled syringes of Sterile Water Diluent Component contain natural rubber latex. The plungers of the syringes and the stoppers of the Lyophilized Antigen Component, Live vials are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-830-34</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (58160-830-34)  &gt; .5 mL in 1 SYRINGE (58160-830-05)</PackageDescription>
    <NDC11Code>58160-0830-34</NDC11Code>
    <ProductNDC>58160-830</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Cervarix</ProprietaryName>
    <NonProprietaryName>Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20091016</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125259</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN</SubstanceName>
    <StrengthNumber>20; 20</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58160-830-52</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (58160-830-52)  &gt; .5 mL in 1 SYRINGE (58160-830-43)</PackageDescription>
    <NDC11Code>58160-0830-52</NDC11Code>
    <ProductNDC>58160-830</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Cervarix</ProprietaryName>
    <NonProprietaryName>Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20091016</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125259</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN</SubstanceName>
    <StrengthNumber>20; 20</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58160-854-52</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (58160-854-52)  *  10 VIAL in 1 CARTON (58160-851-10)  / 1 mL in 1 VIAL (58160-851-01)  *  1 mL in 1 APPLICATOR (58160-853-02) </PackageDescription>
    <NDC11Code>58160-0854-52</NDC11Code>
    <ProductNDC>58160-854</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Rotarix</ProprietaryName>
    <NonProprietaryName>Rotavirus Vaccine, Live, Oral</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20110113</StartMarketingDate>
    <EndMarketingDate>20250224</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125265</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110113</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250224</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.</IndicationAndUsage>
    <Description>ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus vaccine strain is propagated on Vero cells. There are two formulations of ROTARIX: a reconstituted lyophilized formulation (supplied in a vial and oral dosing applicator presentation) and a liquid formulation (supplied in an oral dosing applicator only presentation). Formulation for the Vial and Oral Dosing Applicator Presentation. After reconstitution of the lyophilized vaccine component, each 1 mL dose of the ROTARIX formulation for the vial and oral dosing applicator presentation contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The lyophilized vaccine component of this ROTARIX formulation contains amino acids, dextran, Dulbecco’s Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in this ROTARIX formulation. PCV-1 is not known to cause disease in humans. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral dosing applicator of liquid diluent [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex; the vial stoppers are not made with natural rubber latex. This ROTARIX formulation contains no preservatives. Formulation for the Oral Dosing Applicator Only Presentation. Each 1.5 mL dose of the ROTARIX formulation for the oral dosing applicator only presentation contains at least 106.0 CCID50 of live, attenuated rotavirus. This ROTARIX formulation contains disodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sucrose, and sterile water. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. This ROTARIX formulation contains an antacid component (disodium adipate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose prefilled oral dosing applicator [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex. This ROTARIX formulation contains no preservatives.</Description>
  </NDC>
  <NDC>
    <NDCCode>58160-903-52</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (58160-903-52)  &gt; .5 mL in 1 SYRINGE (58160-903-41)</PackageDescription>
    <NDC11Code>58160-0903-52</NDC11Code>
    <ProductNDC>58160-903</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
    <ProprietaryNameSuffix>2015/2016</ProprietaryNameSuffix>
    <NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20150701</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125127</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58160-976-20</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (58160-976-20)  / .5 mL in 1 SYRINGE (58160-976-02) </PackageDescription>
    <NDC11Code>58160-0976-20</NDC11Code>
    <ProductNDC>58160-976</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Bexsero</ProprietaryName>
    <NonProprietaryName>Neisseria Meningitidis Serogroup B Nhba Fusion Protein Antigen, Neisseria Meningitidis Serogroup B Fhbp Fusion Protein Antigen And Neisseria Meningitidis Serogroup B Nada Protein Antigen</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20161201</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125546</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <SubstanceName>NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN</SubstanceName>
    <StrengthNumber>50; 50; 50; 25</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals aged 10 through 25 years.</IndicationAndUsage>
    <Description>BEXSERO (Meningococcal Group B Vaccine) is a sterile, white, opalescent, injectable suspension for intramuscular use. Each 0.5-mL dose of BEXSERO is formulated to contain 50 mcg each of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), and 25 mcg of Outer Membrane Vesicles (OMV), 1.5 mg aluminum hydroxide (0.519 mg of Al3+), 3.125 mg sodium chloride, 0.776 mg histidine, and 10 mg sucrose at pH 6.4 to 6.7. The NadA component is a fragment of the full-length protein derived from N. meningitidis strain 2996 (peptide 8 variant 2/3)1. The NHBA component is a recombinant fusion protein comprised of NHBA (peptide 2)1 and accessory protein 953 derived from N. meningitidis strains NZ98/254 and 2996, respectively. The fHbp component is a recombinant fusion protein comprised of fHbp (variant 1.1)1 and the accessory protein 936 derived from N. meningitidis strains MC58 and 2996, respectively. These 3 recombinant proteins are individually produced in Escherichia coli and purified through a series of column chromatography steps. The OMV antigenic component is produced by fermentation of N. meningitidis strain NZ98/254 (expressing outer membrane protein Porin A [PorA] serosubtype P1.4)2, followed by inactivation of the bacteria by deoxycholate, which also mediates vesicle formation. The antigens are adsorbed onto aluminum hydroxide. Each dose contains less than 0.01 mcg kanamycin (by calculation). The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>10237-819-60</NDCCode>
    <PackageDescription>170 g in 1 CAN (10237-819-60)</PackageDescription>
    <NDC11Code>10237-0819-60</NDC11Code>
    <ProductNDC>10237-819</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Arrid Extra Extra Dry Xx</ProprietaryName>
    <ProprietaryNameSuffix>Ultra Clear Ultra Clean</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110422</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
    <StrengthNumber>246</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>11673-819-08</NDCCode>
    <PackageDescription>80 TABLET in 1 BOTTLE (11673-819-08) </PackageDescription>
    <NDC11Code>11673-0819-08</NDC11Code>
    <ProductNDC>11673-819</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naproxen Sodium And Diphenhydramine Hcl</ProprietaryName>
    <NonProprietaryName>Naproxen Sodium And Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213663</ApplicationNumber>
    <LabelerName>TARGET CORPORATION</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM</SubstanceName>
    <StrengthNumber>25; 220</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> for relief of occasional sleeplessness when associated with minor aches and pains  helps you fall asleep and stay asleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-819-01</NDCCode>
    <PackageDescription>10 CAPSULE in 1 CARTON (16714-819-01) </PackageDescription>
    <NDC11Code>16714-0819-01</NDC11Code>
    <ProductNDC>16714-819</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
    <NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180903</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209438</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180903</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oseltamivir phosphate  is an influenza neuraminidase inhibitor (NAI) indicated for:  Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)  Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use:   Not a substitute for annual influenza vaccination. (1.3)  Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3)  Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
    <Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as:  Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&amp;C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch.  Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>58160-819-12</NDCCode><ProprietaryName>Shingrix</ProprietaryName><NonProprietaryName>Zoster Vaccine Recombinant, Adjuvanted</NonProprietaryName></NDC><NDC><NDCCode>58160-882-12</NDCCode><ProprietaryName>Arexvy</ProprietaryName><NonProprietaryName>Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted</NonProprietaryName></NDC><NDC><NDCCode>58160-964-12</NDCCode><ProprietaryName>Rabavert</ProprietaryName><NonProprietaryName>Rabies Vaccine</NonProprietaryName></NDC><NDC><NDCCode>30142-819-12</NDCCode><ProprietaryName>Simple Truth Mineral Based Spf 50 Sunscreen</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>37000-819-12</NDCCode><ProprietaryName>Crest Complete Multi-benefit</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>59779-819-58</NDCCode><ProprietaryName>Sensitive Tooth Paste</ProprietaryName><NonProprietaryName>Fluoride</NonProprietaryName></NDC><NDC><NDCCode>63868-819-12</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Fexofenadine Hydrochloride 60 Mg</NonProprietaryName></NDC><NDC><NDCCode>69097-819-12</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</NonProprietaryName></NDC><NDC><NDCCode>69842-929-12</NDCCode><ProprietaryName>Tussin Dm Max Daytime Nighttime</ProprietaryName><NonProprietaryName>Dextromethorphan Hbr, Doxylamine Succinate, Guaifesesin</NonProprietaryName></NDC><NDC><NDCCode>74000-819-12</NDCCode><ProprietaryName>Yellowhammer Brewing Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethanol</NonProprietaryName></NDC><NDC><NDCCode>58160-726-15</NDCCode><ProprietaryName>Hiberix</ProprietaryName><NonProprietaryName>Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)</NonProprietaryName></NDC><NDC><NDCCode>58160-740-21</NDCCode><ProprietaryName>Rotarix</ProprietaryName><NonProprietaryName>Rotavirus Vaccine, Live, Oral</NonProprietaryName></NDC><NDC><NDCCode>58160-806-05</NDCCode><ProprietaryName>Hiberix</ProprietaryName><NonProprietaryName>Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)</NonProprietaryName></NDC><NDC><NDCCode>58160-809-05</NDCCode><ProprietaryName>Menhibrix</ProprietaryName><NonProprietaryName>Meningococcal Groups C And Y And Haemophilus B Tetanus Toxoid Conjugate Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-810-11</NDCCode><ProprietaryName>Infanrix</ProprietaryName><NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed</NonProprietaryName></NDC><NDC><NDCCode>58160-815-11</NDCCode><ProprietaryName>Twinrix</ProprietaryName><NonProprietaryName>Hepatitis A And Hepatitis B (recombinant) Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-815-34</NDCCode><ProprietaryName>Twinrix</ProprietaryName><NonProprietaryName>Hepatitis A And Hepatitis B (recombinant) Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-818-11</NDCCode><ProprietaryName>Hiberix</ProprietaryName><NonProprietaryName>Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)</NonProprietaryName></NDC><NDC><NDCCode>58160-820-52</NDCCode><ProprietaryName>Engerix-b</ProprietaryName><NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>58160-821-11</NDCCode><ProprietaryName>Engerix-b</ProprietaryName><NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>58160-821-52</NDCCode><ProprietaryName>Engerix-b</ProprietaryName><NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>58160-824-15</NDCCode><ProprietaryName>Priorix</ProprietaryName><NonProprietaryName>Measels, Mumps, And Rubella Vaccine, Live</NonProprietaryName></NDC><NDC><NDCCode>58160-830-34</NDCCode><ProprietaryName>Cervarix</ProprietaryName><NonProprietaryName>Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant</NonProprietaryName></NDC><NDC><NDCCode>58160-830-52</NDCCode><ProprietaryName>Cervarix</ProprietaryName><NonProprietaryName>Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant</NonProprietaryName></NDC><NDC><NDCCode>58160-854-52</NDCCode><ProprietaryName>Rotarix</ProprietaryName><NonProprietaryName>Rotavirus Vaccine, Live, Oral</NonProprietaryName></NDC><NDC><NDCCode>58160-903-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-976-20</NDCCode><ProprietaryName>Bexsero</ProprietaryName><NonProprietaryName>Neisseria Meningitidis Serogroup B Nhba Fusion Protein Antigen, Neisseria Meningitidis Serogroup B Fhbp Fusion Protein Antigen And Neisseria Meningitidis Serogroup B Nada Protein Antigen</NonProprietaryName></NDC><NDC><NDCCode>10237-819-60</NDCCode><ProprietaryName>Arrid Extra Extra Dry Xx</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>11673-819-08</NDCCode><ProprietaryName>Naproxen Sodium And Diphenhydramine Hcl</ProprietaryName><NonProprietaryName>Naproxen Sodium And Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>16714-819-01</NDCCode><ProprietaryName>Oseltamivir Phosphate</ProprietaryName><NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
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      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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