RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "0006-4171-00",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4171-00)  / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4171-01) ",
      "NDC11Code": "00006-4171-00",
      "ProductNDC": "0006-4171",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Proquad",
      "NonProprietaryName": "Measles, Mumps, Rubella And Varicella Virus Vaccine Live",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "20150701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125108",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN; MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN; RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN; VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN",
      "StrengthNumber": "1000; 20000; 1000; 9772",
      "StrengthUnit": "[TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL; [PFU]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Chickenpox Vaccine [CS], Herpes Zoster Vaccine [CS], Live Attenuated Herpes Zoster Virus Vaccine [EPC], Live Attenuated Measles Virus Vaccine [EPC], Live Attenuated Mumps Virus Vaccine [EPC], Live Attenuated Rubella Virus Vaccine [EPC], Live Attenuated Varicella Zoster Virus Vaccine [EPC], Measles Vaccine [CS], Mumps Vaccine [CS], Rubella Vaccine [CS], Vaccines, Attenuated [CS], Vaccines, Attenuated [CS], Vaccines, Attenuated [CS], Vaccines, Attenuated [CS]",
      "Status": "Active",
      "LastUpdate": "2025-11-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150701",
      "SamplePackage": "N",
      "IndicationAndUsage": "ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age.",
      "Description": "ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) is a combined, attenuated, live virus vaccine containing measles, mumps, rubella, and varicella viruses. ProQuad is a sterile lyophilized preparation of (1) the components of M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live): Measles Virus Vaccine Live, a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; Mumps Virus Vaccine Live, the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell culture; Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts; and (2) Varicella Virus Vaccine Live (Oka/Merck), the Oka/Merck strain of varicella-zoster virus propagated in MRC-5 cells. The cells, virus pools, bovine serum, and recombinant human albumin used in manufacturing are all tested to provide assurance that the final product is free of potential adventitious agents. ProQuad, when reconstituted as directed, is a sterile injectable suspension for intramuscular or subcutaneous use. Each approximately 0.5 mL dose contains not less than 3.00 log10 TCID50 of measles virus; 4.30 log10 TCID50 of mumps virus; 3.00 log10 TCID50 of rubella virus; and not less than 3.99 log10 PFU of Oka/Merck varicella virus. After reconstitution, each 0.5 mL dose of the vaccine also contains 21 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.4 mg of sodium chloride, 1.8 mg of sorbitol, 0.40 mg of monosodium L-glutamate, 0.34 mg of sodium phosphate dibasic, 0.31 mg of recombinant human albumin, 0.17 mg of sodium bicarbonate, 72 mcg of potassium phosphate monobasic, 60 mcg of potassium chloride; 36 mcg of potassium phosphate dibasic; and residual components from the manufacturing process: MRC-5 cells including DNA and protein; <16 mcg of neomycin, ≤0.5 mcg of bovine calf serum, and other buffer and media ingredients. The product contains no preservative."
    },
    {
      "NDCCode": "0498-4171-01",
      "PackageDescription": "1 KIT in 1 KIT (0498-4171-01)  *  30 mL in 1 BOTTLE (0498-0100-01)  *  .3 mL in 1 POUCH (0498-0121-00)  *  .9 g in 1 PACKET",
      "NDC11Code": "00498-4171-01",
      "ProductNDC": "0498-4171",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "4171 First Aid Kit",
      "NonProprietaryName": "4171 First Aid Kit",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20181018",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Honeywell Safety Products USA, INC",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20181018",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0591-4171-00",
      "PackageDescription": "6234 CAPSULE in 1 BOX (0591-4171-00) ",
      "NDC11Code": "00591-4171-00",
      "ProductNDC": "0591-4171",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Penicillamine",
      "DosageFormName": "CAPSULE",
      "StartMarketingDate": "20190625",
      "EndMarketingDate": "20270630",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Actavis Pharma, Inc.",
      "SubstanceName": "PENICILLAMINE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-04-01",
      "StartMarketingDatePackage": "25-JUN-19",
      "EndMarketingDatePackage": "30-JUN-27"
    },
    {
      "NDCCode": "50090-4171-0",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-4171-0) ",
      "NDC11Code": "50090-4171-00",
      "ProductNDC": "50090-4171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carvedilol",
      "NonProprietaryName": "Carvedilol",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077614",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "CARVEDILOL",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190306",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients(1.2), 3 hypertension(1.3).",
      "Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol, USP is a white to almost white crystalline powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Each carvedilol tablet, USP intended for oral administration contains 3.125 mg or 6.25 mg or 12.5 mg or 25 mg of carvedilol. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide. The product meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "53002-4171-0",
      "PackageDescription": "100 TABLET in 1 BOTTLE (53002-4171-0) ",
      "NDC11Code": "53002-4171-00",
      "ProductNDC": "53002-4171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glyburide",
      "NonProprietaryName": "Glyburide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950830",
      "EndMarketingDate": "20241231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074388",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "SubstanceName": "GLYBURIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240101",
      "EndMarketingDatePackage": "20241231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "54868-4171-0",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-4171-0)",
      "NDC11Code": "54868-4171-00",
      "ProductNDC": "54868-4171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010110",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074761",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days.",
      "Description": "Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula is. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Each tablet for oral administration contains 10 mg ketorolac tromethamine, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "55154-4171-0",
      "PackageDescription": "10 BLISTER PACK in 1 BAG (55154-4171-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "55154-4171-00",
      "ProductNDC": "55154-4171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078993",
      "LabelerName": "Cardinal Health 107, LLC",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-09-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
      "Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration.The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water.  In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red.Meets USP dissolution test 2."
    },
    {
      "NDCCode": "70518-4171-0",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4171-0) ",
      "NDC11Code": "70518-4171-00",
      "ProductNDC": "70518-4171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240828",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078403",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240828",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]:  Major depressive disorder (MDD)  Obsessive-compulsive disorder (OCD)  Panic disorder (PD)  Posttraumatic stress disorder (PTSD)  Social anxiety disorder (SAD)  Premenstrual dysphoric disorder (PMDD).",
      "Description": "Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3."
    },
    {
      "NDCCode": "0006-3025-00",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3025-00)  / 40 mL in 1 VIAL, SINGLE-DOSE (0006-3025-01) ",
      "NDC11Code": "00006-3025-00",
      "ProductNDC": "0006-3025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zinplava",
      "NonProprietaryName": "Bezlotoxumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20161021",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761046",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "BEZLOTOXUMAB",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161021",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZINPLAVA is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence.",
      "Description": "Bezlotoxumab is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects. Bezlotoxumab is an IgG1 immunoglobulin with an approximate molecular weight of 148.2 kDa. ZINPLAVA (bezlotoxumab) Injection is a sterile, preservative-free, clear to moderately opalescent, colorless to pale yellow solution that requires dilution for intravenous infusion. The product is provided in a 50 mL vial that contains 1000 mg of bezlotoxumab in 40 mL of solution. Each mL of solution contains bezlotoxumab (25 mg), citric acid monohydrate (0.8 mg), diethylenetriaminepentaacetic acid (0.0078 mg), polysorbate 80 (0.25 mg), sodium chloride (8.77 mg), sodium citrate dihydrate (4.75 mg), and Water for Injection, USP. The vial may contain sodium hydroxide to adjust the pH to 6.0."
    },
    {
      "NDCCode": "0006-3061-00",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-00)  / 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-01) ",
      "NDC11Code": "00006-3061-00",
      "ProductNDC": "0006-3061",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Emend",
      "NonProprietaryName": "Fosaprepitant Dimeglumine",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170203",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022023",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "FOSAPREPITANT DIMEGLUMINE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170203",
      "SamplePackage": "N",
      "IndicationAndUsage": "EMEND® for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: : 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin., 2 delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).",
      "Description": "EMEND (fosaprepitant) for injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]phosphonate (2:1) (salt). Its empirical formula is C23H22F7N4O6P ∙ 2(C7H17NO5) and its structural formula is. Fosaprepitant dimeglumine is a white to off-white amorphous powder with a molecular weight of 1004.83. It is freely soluble in water. Each vial of EMEND for injection for administration as an intravenous infusion contains 150 mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: edetate disodium (5.4 mg), polysorbate 80 (75 mg), lactose anhydrous (375 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment)."
    },
    {
      "NDCCode": "0006-3335-00",
      "PackageDescription": "1 kg in 1 DRUM (0006-3335-00)",
      "NDC11Code": "00006-3335-00",
      "ProductNDC": "0006-3335",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cilastatin Sodium",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19870108",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "CILASTATIN SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0006-3340-00",
      "PackageDescription": "1 kg in 1 DRUM (0006-3340-00)",
      "NDC11Code": "00006-3340-00",
      "ProductNDC": "0006-3340",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Ertapenem Sodium",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20011121",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "ERTAPENEM SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0006-4045-00",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4045-00)  / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4045-01) ",
      "NDC11Code": "00006-4045-00",
      "ProductNDC": "0006-4045",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Gardasil",
      "NonProprietaryName": "Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) Vaccine, Recombinant",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20060608",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125126",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN",
      "StrengthNumber": "20; 40; 40; 20",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Human Papillomavirus Vaccine [EPC], Inactivated Human Papillomavirus Vaccine [EPC], Inactivated Human Papillomavirus Vaccine [EPC], Inactivated Human Papillomavirus Vaccine [EPC], Papillomavirus Vaccines [CS], Papillomavirus Vaccines [CS], Papillomavirus Vaccines [CS], Papillomavirus Vaccines [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20060608",
      "SamplePackage": "N",
      "IndicationAndUsage": "GARDASIL is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine: 1 Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18. (1.1), 2 Genital warts (condyloma acuminata) caused by HPV types 6 and 11. (1.1).",
      "Description": "GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant, is a non-infectious recombinant quadrivalent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18. The L1 proteins are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs. The fermentation process involves growth of S. cerevisiae on chemically-defined fermentation media which include vitamins, amino acids, mineral salts, and carbohydrates. The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods. The purified VLPs are adsorbed on preformed aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate). The quadrivalent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer. GARDASIL is a sterile suspension for intramuscular administration. Each 0.5-mL dose contains approximately 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein. Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, <7 mcg yeast protein/dose, and water for injection. The product does not contain a preservative or antibiotics. After thorough agitation, GARDASIL is a white, cloudy liquid."
    },
    {
      "NDCCode": "0006-4084-00",
      "PackageDescription": "1 KIT in 1 CARTON (0006-4084-00)  *  1 mL in 1 VIAL (0006-9011-00)  *  2.5 mL in 1 VIAL (0006-9002-00)  *  2.5 mL in 1 VIAL",
      "NDC11Code": "00006-4084-00",
      "ProductNDC": "0006-4084",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Antivenin",
      "NonProprietaryName": "Latrodectus Mactans",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19470514",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101062",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "Status": "Deprecated",
      "LastUpdate": "2015-03-27"
    },
    {
      "NDCCode": "0006-4309-00",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4309-00)  / .7 mL in 1 VIAL, SINGLE-DOSE (0006-4309-01) ",
      "NDC11Code": "00006-4309-00",
      "ProductNDC": "0006-4309",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Sterile Diluent",
      "NonProprietaryName": "Sterile Water",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "20060525",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125123",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "WATER",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/.7mL",
      "Status": "Active",
      "LastUpdate": "2025-12-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20060525",
      "SamplePackage": "N",
      "IndicationAndUsage": "M-M-R II is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.",
      "Description": "M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; (2) Mumps Virus Vaccine Live, the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell culture; and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts. {21,22} The cells, virus pools, recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and determined to be free of adventitious agents. M-M-R II is an injectable suspension for intramuscular or subcutaneous use. After reconstitution, each approximately 0.5 mL dose contains not less than 3.0 log10 TCID50 (tissue culture infectious doses) of measles virus; 4.1 log10 TCID50 of mumps virus; and 3.0 log10 TCID50 of rubella virus. Each dose is calculated to contain sorbitol (14.5 mg), sucrose (1.9 mg), hydrolyzed gelatin (14.5 mg), recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin and other buffer and media ingredients. The product contains no preservative."
    },
    {
      "NDCCode": "0006-4681-00",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4681-00)  / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4681-01) ",
      "NDC11Code": "00006-4681-00",
      "ProductNDC": "0006-4681",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "M-m-r Ii",
      "NonProprietaryName": "Measles, Mumps, And Rubella Virus Vaccine Live",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "19710421",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101069",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN; MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN; RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN",
      "StrengthNumber": "1000; 12500; 1000",
      "StrengthUnit": "[TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Live Attenuated Measles Virus Vaccine [EPC], Live Attenuated Mumps Virus Vaccine [EPC], Live Attenuated Rubella Virus Vaccine [EPC], Measles Vaccine [CS], Mumps Vaccine [CS], Rubella Vaccine [CS], Vaccines, Attenuated [CS], Vaccines, Attenuated [CS], Vaccines, Attenuated [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19710421",
      "SamplePackage": "N",
      "IndicationAndUsage": "M-M-R II is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.",
      "Description": "M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; (2) Mumps Virus Vaccine Live, the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell culture; and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts. {21,22} The cells, virus pools, recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and determined to be free of adventitious agents. M-M-R II is an injectable suspension for intramuscular or subcutaneous use. After reconstitution, each approximately 0.5 mL dose contains not less than 3.0 log10 TCID50 (tissue culture infectious doses) of measles virus; 4.1 log10 TCID50 of mumps virus; and 3.0 log10 TCID50 of rubella virus. Each dose is calculated to contain sorbitol (14.5 mg), sucrose (1.9 mg), hydrolyzed gelatin (14.5 mg), recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin and other buffer and media ingredients. The product contains no preservative."
    },
    {
      "NDCCode": "0006-4739-00",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0006-4739-00)  > .5 mL in 1 VIAL, MULTI-DOSE (0006-4739-01)",
      "NDC11Code": "00006-4739-00",
      "ProductNDC": "0006-4739",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Pneumovax 23",
      "NonProprietaryName": "Pneumococcal Vaccine Polyvalent",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "19830707",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101094",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN",
      "StrengthNumber": "25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Pharm_Classes": "Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-07",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0006-4826-00",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4826-00)  / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4826-01) ",
      "NDC11Code": "00006-4826-00",
      "ProductNDC": "0006-4826",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Varivax",
      "NonProprietaryName": "Varicella Virus Vaccine Live",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19950317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103552",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN",
      "StrengthNumber": "1350",
      "StrengthUnit": "[PFU]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Chickenpox Vaccine [CS], Herpes Zoster Vaccine [CS], Live Attenuated Herpes Zoster Virus Vaccine [EPC], Live Attenuated Varicella Zoster Virus Vaccine [EPC], Vaccines, Attenuated [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19950317",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0006-4827-00",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4827-00)  / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4827-01) ",
      "NDC11Code": "00006-4827-00",
      "ProductNDC": "0006-4827",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Varivax",
      "NonProprietaryName": "Varicella Virus Vaccine Live",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19950317",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103552",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN",
      "StrengthNumber": "1350",
      "StrengthUnit": "[PFU]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Chickenpox Vaccine [CS], Herpes Zoster Vaccine [CS], Live Attenuated Herpes Zoster Virus Vaccine [EPC], Live Attenuated Varicella Zoster Virus Vaccine [EPC], Vaccines, Attenuated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19950317",
      "SamplePackage": "N",
      "IndicationAndUsage": "VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.",
      "Description": "VARIVAX [Varicella Virus Vaccine Live] is a preparation of the Oka/Merck strain of live, attenuated varicella virus. The virus was initially obtained from a child with wild-type varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Research Laboratories of Merck Sharp & Dohme, LLC, Rahway, NJ, USA in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers. VARIVAX, when reconstituted as directed, is a sterile preparation for intramuscular or subcutaneous injection. Each approximately 0.5 mL dose contains a minimum of 1350 plaque-forming units (PFU) of Oka/Merck varicella virus when reconstituted and stored at room temperature for a maximum of 30 minutes. Each approximately 0.5 mL dose also contains approximately 24 mg of sucrose, 12.0 mg hydrolyzed gelatin, 3.1 mg of sodium chloride, 0.5 mg of monosodium L-glutamate, 0.44 mg of sodium phosphate dibasic, 0.08 mg of potassium phosphate monobasic, and 0.08 mg of potassium chloride. The product also contains residual components of MRC-5 cells including DNA and protein and trace quantities of sodium phosphate monobasic, EDTA, neomycin and fetal bovine serum. The product contains no preservative."
    },
    {
      "NDCCode": "0006-4841-00",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4841-00)  / 1 mL in 1 VIAL, SINGLE-DOSE (0006-4841-01) ",
      "NDC11Code": "00006-4841-00",
      "ProductNDC": "0006-4841",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Vaqta",
      "NonProprietaryName": "Hepatitis A Vaccine, Inactivated",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19960329",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103606",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "50",
      "StrengthUnit": "[iU]/mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19960329",
      "SamplePackage": "N",
      "IndicationAndUsage": "VAQTA is a vaccine indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV. (1.1).",
      "Description": "VAQTA is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, purified by a combination of physical and high performance liquid chromatographic techniques developed at the Research Laboratories of Merck Sharp & Dohme LLC, Rahway, NJ, USA, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulfate. VAQTA is a sterile suspension for intramuscular injection. One milliliter of the vaccine contains approximately 50U of hepatitis A virus antigen, which is purified and formulated without a preservative. Within the limits of current assay variability, the 50U dose of VAQTA contains less than 0.1 mcg of non-viral protein, less than 4 × 10–6 mcg of DNA, less than 10–4 mcg of bovine albumin, and less than 0.8 mcg of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb), including neomycin. Each 0.5-mL pediatric dose contains 25U of hepatitis A virus antigen and adsorbed onto approximately 0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride. Each 1-mL adult dose contains 50U of hepatitis A virus antigen and adsorbed onto approximately 0.45 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 70 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride."
    },
    {
      "NDCCode": "0006-4897-00",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4897-00)  / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4897-01) ",
      "NDC11Code": "00006-4897-00",
      "ProductNDC": "0006-4897",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Pedvaxhib",
      "NonProprietaryName": "Haemophilus B Conjugate Vaccine (meningococcal Protein Conjugate)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19891220",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103237",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN",
      "StrengthNumber": "7.5",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Haemophilus Vaccines [CS], Inactivated Haemophilus Influenzae B Vaccine [EPC], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19891220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Liquid PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age. Liquid PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis. As with any vaccine, vaccination with Liquid PedvaxHIB may not result in a protective antibody response in all individuals given the vaccine. BECAUSE OF THE POTENTIAL FOR IMMUNE TOLERANCE, Liquid PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE. (See PRECAUTIONS.).",
      "Description": "PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is a highly purified capsular polysaccharide (polyribosylribitol phosphate or PRP) of Haemophilus influenzae type b (Haemophilus b, Ross strain) that is covalently bound to an outer membrane protein complex (OMPC) of the B11 strain of Neisseria meningitidis serogroup B. The covalent bonding of the PRP to the OMPC which is necessary for enhanced immunogenicity of the PRP is confirmed by quantitative analysis of the conjugate's components following chemical treatment which yields a unique amino acid. The potency of PedvaxHIB is determined by assay of PRP. Haemophilus influenzae type b and Neisseria meningitidis serogroup B are grown in complex fermentation media. The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. The OMPC from Neisseria meningitidis is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration. Liquid PedvaxHIB is ready to use and does not require a diluent. Each 0.5 mL dose of Liquid PedvaxHIB is a sterile product formulated to contain: 7.5 mcg of Haemophilus b PRP, 125 mcg of Neisseria meningitidis OMPC and 225 mcg of aluminum as amorphous aluminum hydroxyphosphate sulfate (previously referred to as aluminum hydroxide), in 0.9% sodium chloride, but does not contain lactose or thimerosal. Liquid PedvaxHIB is a slightly opaque white suspension. This vaccine is for intramuscular administration and not for intravenous injection. (See DOSAGE AND ADMINISTRATION.)."
    },
    {
      "NDCCode": "0006-4898-00",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4898-00)  > .5 mL in 1 VIAL, SINGLE-DOSE (0006-4898-01)",
      "NDC11Code": "00006-4898-00",
      "ProductNDC": "0006-4898",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Comvax",
      "NonProprietaryName": "Haemophilus B Conjugate (meningococcal Protein Conjugate) And Hepatitis B (recombinant) Vaccine",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19961002",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103623",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN; HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "7.5; 5",
      "StrengthUnit": "ug/.5mL; ug/.5mL",
      "Pharm_Classes": "Inactivated Haemophilus Influenzae B Vaccine [EPC],Actively Acquired Immunity [PE],Haemophilus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0006-4943-00",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4943-00)  / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4943-01) ",
      "NDC11Code": "00006-4943-00",
      "ProductNDC": "0006-4943",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Pneumovax 23",
      "NonProprietaryName": "Pneumococcal Vaccine Polyvalent",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "19830707",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101094",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN",
      "StrengthNumber": "25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19830707",
      "SamplePackage": "N",
      "IndicationAndUsage": "PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). (1.1). PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease. (1.1, 14.1).",
      "Description": "PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine consisting of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). PNEUMOVAX 23 is a clear, colorless solution. Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative. The vaccine is used directly as supplied. No dilution or reconstitution is necessary. The vial stoppers, syringe plunger stopper and syringe tip cap are not made with natural rubber latex."
    },
    {
      "NDCCode": "0006-4963-00",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4963-00)  > .65 mL in 1 VIAL, SINGLE-DOSE (0006-4963-01) ",
      "NDC11Code": "00006-4963-00",
      "ProductNDC": "0006-4963",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Zostavax",
      "NonProprietaryName": "Zoster Vaccine Live",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20060525",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125123",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN",
      "StrengthNumber": "19400",
      "StrengthUnit": "[PFU]/.65mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Chickenpox Vaccine [CS], Herpes Zoster Vaccine [CS], Live Attenuated Herpes Zoster Virus Vaccine [EPC], Live Attenuated Varicella Zoster Virus Vaccine [EPC], Vaccines, Attenuated [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20060525",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0006-4981-00",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4981-00)  / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4981-01) ",
      "NDC11Code": "00006-4981-00",
      "ProductNDC": "0006-4981",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Recombivax Hb",
      "NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "19860723",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101066",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "5",
      "StrengthUnit": "ug/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis B Vaccines [CS], Inactivated Hepatitis B Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19860723",
      "SamplePackage": "N",
      "IndicationAndUsage": "RECOMBIVAX HB® [Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older.",
      "Description": "RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is a sterile suspension of non-infectious subunit viral vaccine derived from HBsAg produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Research Laboratories of Merck Sharp & Dohme LLC, Rahway, NJ, USA. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. Each dose contains less than 1% yeast protein. The vaccine produced by the Merck Sharp & Dohme LLC, Rahway, NJ, USA method has been shown to be comparable to the plasma-derived vaccine in terms of animal potency (mouse, monkey, and chimpanzee) and protective efficacy (chimpanzee and human). The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products. RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations. [See How Supplied/Storage and Handling (16).]. Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen. Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen. Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of hepatitis B surface antigen. All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains <15 mcg/mL residual formaldehyde. The vaccine is of the adw subtype."
    },
    {
      "NDCCode": "0006-4992-00",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4992-00)  / 1 mL in 1 VIAL, SINGLE-DOSE (0006-4992-01) ",
      "NDC11Code": "00006-4992-00",
      "ProductNDC": "0006-4992",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Recombivax Hb",
      "NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "19860723",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101066",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "40",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis B Vaccines [CS], Inactivated Hepatitis B Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19860723",
      "SamplePackage": "N",
      "IndicationAndUsage": "RECOMBIVAX HB® [Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older.",
      "Description": "RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is a sterile suspension of non-infectious subunit viral vaccine derived from HBsAg produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Research Laboratories of Merck Sharp & Dohme LLC, Rahway, NJ, USA. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. Each dose contains less than 1% yeast protein. The vaccine produced by the Merck Sharp & Dohme LLC, Rahway, NJ, USA method has been shown to be comparable to the plasma-derived vaccine in terms of animal potency (mouse, monkey, and chimpanzee) and protective efficacy (chimpanzee and human). The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products. RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations. [See How Supplied/Storage and Handling (16).]. Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen. Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen. Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of hepatitis B surface antigen. All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains <15 mcg/mL residual formaldehyde. The vaccine is of the adw subtype."
    },
    {
      "NDCCode": "0006-4995-00",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4995-00)  / 1 mL in 1 VIAL, SINGLE-DOSE (0006-4995-01) ",
      "NDC11Code": "00006-4995-00",
      "ProductNDC": "0006-4995",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Recombivax Hb",
      "NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "19860723",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101066",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "10",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis B Vaccines [CS], Inactivated Hepatitis B Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19860723",
      "SamplePackage": "N",
      "IndicationAndUsage": "RECOMBIVAX HB® [Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older.",
      "Description": "RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is a sterile suspension of non-infectious subunit viral vaccine derived from HBsAg produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Research Laboratories of Merck Sharp & Dohme LLC, Rahway, NJ, USA. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. Each dose contains less than 1% yeast protein. The vaccine produced by the Merck Sharp & Dohme LLC, Rahway, NJ, USA method has been shown to be comparable to the plasma-derived vaccine in terms of animal potency (mouse, monkey, and chimpanzee) and protective efficacy (chimpanzee and human). The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products. RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations. [See How Supplied/Storage and Handling (16).]. Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen. Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen. Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of hepatitis B surface antigen. All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains <15 mcg/mL residual formaldehyde. The vaccine is of the adw subtype."
    },
    {
      "NDCCode": "0006-4999-00",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4999-00)  > .5 mL in 1 VIAL, SINGLE-DOSE (0006-4999-01) ",
      "NDC11Code": "00006-4999-00",
      "ProductNDC": "0006-4999",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Proquad",
      "NonProprietaryName": "Measles, Mumps, Rubella And Varicella Virus Vaccine Live",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20050906",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125108",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN; MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN; RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN; VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN",
      "StrengthNumber": "1000; 20000; 1000; 9772",
      "StrengthUnit": "[TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL; [PFU]/.5mL",
      "Pharm_Classes": "Live Attenuated Measles Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Measles Vaccine [Chemical/Ingredient],Live Attenuated Mumps Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Mumps Vaccine [Chemical/Ingredient],Live Attenuated Rubella Virus Vaccine [EPC],Actively Acquired Immunity [PE],Rubella Vaccine [Chemical/Ingredient],Vaccines, Attenuated [Chemical/Ingredient],Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Chickenpox Vaccine [Chemical/Ingredient],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20050906",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0006-5424-02",
      "PackageDescription": "1 KIT in 1 CARTON (0006-5424-02)  *  2.5 mL in 1 VIAL (0006-4084-01)  *  1 mL in 1 VIAL (0006-9011-00) ",
      "NDC11Code": "00006-5424-02",
      "ProductNDC": "0006-5424",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Antivenin",
      "NonProprietaryName": "Latrodectus Mactans",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141201",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101062",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20141201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Antivenin (Latrodectus mactans) is used to treat patients with symptoms due to bites by the black widow spider (Latrodectus mactans). Early use of the Antivenin is emphasized for prompt relief. Local muscular cramps begin from 15 minutes to several hours after the bite which usually produces a sharp pain similar to that caused by puncture with a needle. The exact sequence of symptoms depends somewhat on the location of the bite. The venom acts on the myoneural junctions or on the nerve endings, causing an ascending motor paralysis or destruction of the peripheral nerve endings. The groups of muscles most frequently affected at first are those of the thigh, shoulder, and back. After a varying length of time, the pain becomes more severe, spreading to the abdomen, and weakness and tremor usually develop. The abdominal muscles assume a boardlike rigidity, but tenderness is slight. Respiration is thoracic. The patient is restless and anxious. Feeble pulse, cold, clammy skin, labored breathing and speech, light stupor, and delirium may occur. Convulsions also may occur, particularly in small children. The temperature may be normal or slightly elevated. Urinary retention, shock, cyanosis, nausea and vomiting, insomnia, and cold sweats also have been reported. The syndrome following the bite of the black widow spider may be confused easily with any medical or surgical condition with acute abdominal symptoms. The symptoms of black widow spider bite increase in severity for several hours, perhaps a day, and then very slowly become less severe, gradually passing off in the course of two or three days except in fatal cases. Residual symptoms such as general weakness, tingling, nervousness, and transient muscle spasm may persist for weeks or months after recovery from the acute stage. If possible, the patient should be hospitalized. Other additional measures giving greatest relief are prolonged warm baths and intravenous injection of 10 mL of 10 percent solution of calcium gluconate repeated as necessary to control muscle pain. Morphine also may be required to control pain. Barbiturates may be used for extreme restlessness. However, as the venom is a neurotoxin, it can cause respiratory paralysis. This must be borne in mind when considering use of morphine or a barbiturate. Adrenocorticosteroids have been used with varying degrees of success. Supportive therapy is indicated by the condition of the patient. Local treatment of the site of the bite is of no value. Nothing is gained by applying a tourniquet or by attempting to remove venom from the site of the bite by incision and suction. In otherwise healthy individuals between the ages of 16 and 60, the use of Antivenin may be deferred and treatment with muscle relaxants may be considered.",
      "Description": "Antivenin (Latrodectus mactans) is a sterile, non-pyrogenic preparation derived by drying a frozen solution of specific venom-neutralizing globulins obtained from the blood serum of healthy horses immunized against venom of black widow spiders (Latrodectus mactans). It is standardized by biological assay on mice, in terms of one dose of Antivenin neutralizing the venom in not less than 6000 mouse LD50 of Latrodectus mactans. Thimerosal (mercury derivative) 1:10,000 is added as a preservative. When constituted as specified, it is opalescent, ranging in color from light (straw) to very dark (iced tea), and contains not more than 20.0 percent of solids. Each single-dose vial contains not less than 6000 Antivenin units. One unit of Antivenin will neutralize one average mouse lethal dose of black widow spider venom when the Antivenin and the venom are injected simultaneously in mice under suitable conditions."
    },
    {
      "NDCCode": "10210-0006-0",
      "PackageDescription": "4.25 g in 1 CYLINDER (10210-0006-0)",
      "NDC11Code": "10210-0006-00",
      "ProductNDC": "10210-0006",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Carmex Vanilla Broad Spectrum Spf 15 Sunscreen",
      "NonProprietaryName": "Avobenzone, Octisalate, Homosalate, Octocrylene",
      "DosageFormName": "SALVE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130926",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Carma Laboratories, Inc.",
      "SubstanceName": "AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE",
      "StrengthNumber": "2.5; 3; 5; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-23",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    }
  ]
}
                    

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