RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "42494-415-25",
      "PackageDescription": "25 VIAL in 1 BOX, UNIT-DOSE (42494-415-25)  / 1 mL in 1 VIAL",
      "NDC11Code": "42494-0415-25",
      "ProductNDC": "42494-415",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenobarbital Sodium",
      "NonProprietaryName": "Phenobarbital Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20200205",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "PHENOBARBITAL SODIUM",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates. Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see CLINICAL PHARMACOLOGY). Preanesthetic. Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression. Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.",
      "Description": "The barbiturates are nonselective central nervous system (CNS) depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (CIV). Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system activity. CNS activity is obtained by substituting alkyl, alkenyl or aryl groups on the pyrimidine ring. Phenobarbital Sodium Injection, USP is a sterile solution for intramuscular or slow intravenous administration as a long-acting barbiturate. Each mL contains phenobarbital sodium either 65 mg or 130 mg, alcohol 0.1 mL, propylene glycol 0.678 mL and benzyl alcohol 0.015 mL in Water for Injection; hydrochloric acid added, if needed, for pH adjustment. The pH range is 9.2-10.2. Chemically, phenobarbital sodium is 2,4,6(1H,3H,5H)-Pyrimidinetrione,5-ethyl-5-phenyl-, monosodium salt and has the following structural formula.        C12 H 11 N 2 NaO 3       MW 254.22. The sodium salt of phenobarbital occurs as a white, slightly bitter powder, crystalline granules or flaky crystals; it is soluble in alcohol and practically insoluble in ether or chloroform."
    },
    {
      "NDCCode": "42494-415-03",
      "PackageDescription": "3 VIAL in 1 BOX, UNIT-DOSE (42494-415-03)  / 1 mL in 1 VIAL",
      "NDC11Code": "42494-0415-03",
      "ProductNDC": "42494-415",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenobarbital Sodium",
      "NonProprietaryName": "Phenobarbital Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20200205",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "PHENOBARBITAL SODIUM",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates. Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see CLINICAL PHARMACOLOGY). Preanesthetic. Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression. Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.",
      "Description": "The barbiturates are nonselective central nervous system (CNS) depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (CIV). Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system activity. CNS activity is obtained by substituting alkyl, alkenyl or aryl groups on the pyrimidine ring. Phenobarbital Sodium Injection, USP is a sterile solution for intramuscular or slow intravenous administration as a long-acting barbiturate. Each mL contains phenobarbital sodium either 65 mg or 130 mg, alcohol 0.1 mL, propylene glycol 0.678 mL and benzyl alcohol 0.015 mL in Water for Injection; hydrochloric acid added, if needed, for pH adjustment. The pH range is 9.2-10.2. Chemically, phenobarbital sodium is 2,4,6(1H,3H,5H)-Pyrimidinetrione,5-ethyl-5-phenyl-, monosodium salt and has the following structural formula.        C12 H 11 N 2 NaO 3       MW 254.22. The sodium salt of phenobarbital occurs as a white, slightly bitter powder, crystalline granules or flaky crystals; it is soluble in alcohol and practically insoluble in ether or chloroform."
    },
    {
      "NDCCode": "42494-416-25",
      "PackageDescription": "25 VIAL in 1 BOX, UNIT-DOSE (42494-416-25)  / 1 mL in 1 VIAL",
      "NDC11Code": "42494-0416-25",
      "ProductNDC": "42494-416",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenobarbital Sodium",
      "NonProprietaryName": "Phenobarbital Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20200205",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "PHENOBARBITAL SODIUM",
      "StrengthNumber": "130",
      "StrengthUnit": "mg/mL",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-06-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates. Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see CLINICAL PHARMACOLOGY). Preanesthetic. Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression. Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.",
      "Description": "The barbiturates are nonselective central nervous system (CNS) depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (CIV). Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system activity. CNS activity is obtained by substituting alkyl, alkenyl or aryl groups on the pyrimidine ring. Phenobarbital Sodium Injection, USP is a sterile solution for intramuscular or slow intravenous administration as a long-acting barbiturate. Each mL contains phenobarbital sodium either 65 mg or 130 mg, alcohol 0.1 mL, propylene glycol 0.678 mL and benzyl alcohol 0.015 mL in Water for Injection; hydrochloric acid added, if needed, for pH adjustment. The pH range is 9.2-10.2. Chemically, phenobarbital sodium is 2,4,6(1H,3H,5H)-Pyrimidinetrione,5-ethyl-5-phenyl-, monosodium salt and has the following structural formula.        C12 H 11 N 2 NaO 3       MW 254.22. The sodium salt of phenobarbital occurs as a white, slightly bitter powder, crystalline granules or flaky crystals; it is soluble in alcohol and practically insoluble in ether or chloroform."
    },
    {
      "NDCCode": "42494-435-25",
      "PackageDescription": "25 VIAL in 1 CARTON (42494-435-25)  / 4 mL in 1 VIAL",
      "NDC11Code": "42494-0435-25",
      "ProductNDC": "42494-435",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetylcysteine",
      "NonProprietaryName": "Acetylcysteine",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250821",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214177",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "ACETYLCYSTEINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250821",
      "SamplePackage": "N",
      "Description": "Acetylcysteine solution is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solutions (not for injection). The solutions contain 20% (Acetylcysteine Solution 20%) or 10% (Acetylcysteine Solution 10%) acetylcysteine, with disodium edetate in water for injection. Sodium hydroxide and/or hydrochloric acid is added to adjust to pH (range 6.0 - 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, L-cysteine. The compound is a white crystalline powder with the molecular formula C5H9NO3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula. This product contains the following inactive ingredients: edetate disodium, sodium hydroxide and water for injection."
    },
    {
      "NDCCode": "42494-436-25",
      "PackageDescription": "25 VIAL in 1 CARTON (42494-436-25)  / 4 mL in 1 VIAL",
      "NDC11Code": "42494-0436-25",
      "ProductNDC": "42494-436",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetylcysteine",
      "NonProprietaryName": "Acetylcysteine",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250821",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214177",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "ACETYLCYSTEINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250821",
      "SamplePackage": "N",
      "Description": "Acetylcysteine solution is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solutions (not for injection). The solutions contain 20% (Acetylcysteine Solution 20%) or 10% (Acetylcysteine Solution 10%) acetylcysteine, with disodium edetate in water for injection. Sodium hydroxide and/or hydrochloric acid is added to adjust to pH (range 6.0 - 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, L-cysteine. The compound is a white crystalline powder with the molecular formula C5H9NO3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula. This product contains the following inactive ingredients: edetate disodium, sodium hydroxide and water for injection."
    },
    {
      "NDCCode": "42494-441-25",
      "PackageDescription": "25 VIAL in 1 BOX, UNIT-DOSE (42494-441-25)  / 1 mL in 1 VIAL",
      "NDC11Code": "42494-0441-25",
      "ProductNDC": "42494-441",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenobarbital Sodium",
      "NonProprietaryName": "Phenobarbital Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230602",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "PHENOBARBITAL SODIUM",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230602",
      "SamplePackage": "N",
      "IndicationAndUsage": "a.Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates. b.Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see CLINICAL PHARMACOLOGY). c.Preanesthetic. d.Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression. e.Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.",
      "Description": "The barbiturates are nonselective central nervous system (CNS) depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (CIV). Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system activity. CNS activity is obtained by substituting alkyl, alkenyl or aryl groups on the pyrimidine ring. Phenobarbital Sodium Injection, USP is a sterile solution for intramuscular or slow intravenous administration as a long-acting barbiturate. Each mL contains phenobarbital sodium either 65 mg or 130 mg, alcohol 0.1 mL, propylene glycol 0.678 mL and benzyl alcohol 0.015 mL in Water for Injection; hydrochloric acid added, if needed, for pH adjustment. The pH range is 9.2-10.2. Chemically, phenobarbital sodium is 2,4,6(1H,3H,5H)-Pyrimidinetrione,5-ethyl-5-phenyl-, monosodium salt and has the following structural formula. C12 H 11 N 2 NaO 3    MW 254.22. The sodium salt of phenobarbital occurs as a white, slightly bitter powder, crystalline granules or flaky crystals; it is soluble in alcohol and practically insoluble in ether or chloroform."
    },
    {
      "NDCCode": "42494-442-25",
      "PackageDescription": "3 VIAL in 1 BOX, UNIT-DOSE (42494-442-25)  / 1 mL in 1 VIAL",
      "NDC11Code": "42494-0442-25",
      "ProductNDC": "42494-442",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenobarbital Sodium",
      "NonProprietaryName": "Phenobarbital Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230602",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "PHENOBARBITAL SODIUM",
      "StrengthNumber": "130",
      "StrengthUnit": "mg/mL",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230602",
      "SamplePackage": "N",
      "IndicationAndUsage": "a.Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates. b.Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see CLINICAL PHARMACOLOGY). c.Preanesthetic. d.Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression. e.Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.",
      "Description": "The barbiturates are nonselective central nervous system (CNS) depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (CIV). Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system activity. CNS activity is obtained by substituting alkyl, alkenyl or aryl groups on the pyrimidine ring. Phenobarbital Sodium Injection, USP is a sterile solution for intramuscular or slow intravenous administration as a long-acting barbiturate. Each mL contains phenobarbital sodium either 65 mg or 130 mg, alcohol 0.1 mL, propylene glycol 0.678 mL and benzyl alcohol 0.015 mL in Water for Injection; hydrochloric acid added, if needed, for pH adjustment. The pH range is 9.2-10.2. Chemically, phenobarbital sodium is 2,4,6(1H,3H,5H)-Pyrimidinetrione,5-ethyl-5-phenyl-, monosodium salt and has the following structural formula. C12 H 11 N 2 NaO 3    MW 254.22. The sodium salt of phenobarbital occurs as a white, slightly bitter powder, crystalline granules or flaky crystals; it is soluble in alcohol and practically insoluble in ether or chloroform."
    },
    {
      "NDCCode": "43547-415-25",
      "PackageDescription": "2500 TABLET in 1 BOTTLE (43547-415-25) ",
      "NDC11Code": "43547-0415-25",
      "ProductNDC": "43547-415",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril",
      "NonProprietaryName": "Lisinopril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170830",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075743",
      "LabelerName": "Solco healthcare U.S., LLC",
      "SubstanceName": "LISINOPRIL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170830",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
      "Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Lisinopril Tablets 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg contain the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, mannitol, pregelatinized corn starch and talc."
    },
    {
      "NDCCode": "59779-415-25",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (59779-415-25)  > 25 CAPSULE in 1 BOTTLE, PLASTIC",
      "NDC11Code": "59779-0415-25",
      "ProductNDC": "59779-415",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Indoor/outdoor Allergy Relief Softgels",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130301",
      "EndMarketingDate": "20201231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022429",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20130301",
      "EndMarketingDatePackage": "20201231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71288-415-06",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-415-06)  / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-05) ",
      "NDC11Code": "71288-0415-06",
      "ProductNDC": "71288-415",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glycopyrrolate",
      "NonProprietaryName": "Glycopyrrolate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20210706",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212802",
      "LabelerName": "Meitheal Pharmaceuticals Inc.",
      "SubstanceName": "GLYCOPYRROLATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210706",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glycopyrrolate Injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).",
      "Description": "Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.34. Its structural formula is as follows. C19H28BrNO3             398.34. Glycopyrrolate occurs as a white, odorless, crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. It is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid with a pH of 2.0 to 3.0. The partition coefficient of glycopyrrolate in n-octanol/water system is 0.304 (log10 P = -1.52) at ambient room temperature (24°C). Glycopyrrolate Injection, USP is intended for intramuscular or intravenous administration. Each 1 mL contains 0.2 mg of glycopyrrolate, water for injection, and hydrochloric acid or sodium hydroxide as pH adjusters."
    },
    {
      "NDCCode": "71288-415-96",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-415-96)  / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-95) ",
      "NDC11Code": "71288-0415-96",
      "ProductNDC": "71288-415",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glycopyrrolate",
      "NonProprietaryName": "Glycopyrrolate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20210706",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212802",
      "LabelerName": "Meitheal Pharmaceuticals Inc.",
      "SubstanceName": "GLYCOPYRROLATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210706",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.",
      "Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains. Glycopyrrolate, USP 0.2 mg. Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative). pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.34. Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 – 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
    },
    {
      "NDCCode": "72603-415-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (72603-415-25)  / 30 mL in 1 VIAL, SINGLE-DOSE (72603-415-01) ",
      "NDC11Code": "72603-0415-25",
      "ProductNDC": "72603-415",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine Hydrochloride",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20241001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217821",
      "LabelerName": "NorthStar RxLLC",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection is recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see  Dosage and Administration (2.2)]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see  Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.5, 5.7, 5.9)].",
      "Description": "Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine hydrochloride, USP is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white or almost white, crystalline powder or colorless crystals that is soluble in water, freely soluble in alcohol. It has the molecular formula C 18H 28N 2O.HCl.H 2O and it has the following structural formula:.    Bupivacaine hydrochloride injection, USP is a clear and colorless sterile, isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection."
    },
    {
      "NDCCode": "42494-119-90",
      "PackageDescription": "90 CAPSULE, GELATIN COATED in 1 BOTTLE (42494-119-90)",
      "NDC11Code": "42494-0119-90",
      "ProductNDC": "42494-119",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Se-tan Dha",
      "NonProprietaryName": "Ferrous Fumarate And Polysaccharide Iron",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091001",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "FERROUS FUMARATE; IRON DEXTRAN; SODIUM ASCORBATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; OMEGA-3 FATTY ACIDS; DOCONEXENT; ICOSAPENT",
      "StrengthNumber": "15; 15; 20; 1; 25; 310.1; 215.12; 53.46",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-13"
    },
    {
      "NDCCode": "42494-301-01",
      "PackageDescription": "1 SUPPOSITORY in 1 BLISTER PACK (42494-301-01) ",
      "NDC11Code": "42494-0301-01",
      "ProductNDC": "42494-301",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone Acetate",
      "NonProprietaryName": "Hydrocortisone Acetate",
      "DosageFormName": "SUPPOSITORY",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20170501",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "HYDROCORTISONE ACETATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani.",
      "Description": "Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11ß) with the following structural formula. Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable base."
    },
    {
      "NDCCode": "42494-301-12",
      "PackageDescription": "12 SUPPOSITORY in 1 BOX (42494-301-12) ",
      "NDC11Code": "42494-0301-12",
      "ProductNDC": "42494-301",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone Acetate",
      "NonProprietaryName": "Hydrocortisone Acetate",
      "DosageFormName": "SUPPOSITORY",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20170501",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "HYDROCORTISONE ACETATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani.",
      "Description": "Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11ß) with the following structural formula. Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable base."
    },
    {
      "NDCCode": "42494-301-24",
      "PackageDescription": "24 SUPPOSITORY in 1 BOX (42494-301-24) ",
      "NDC11Code": "42494-0301-24",
      "ProductNDC": "42494-301",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone Acetate",
      "NonProprietaryName": "Hydrocortisone Acetate",
      "DosageFormName": "SUPPOSITORY",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20170501",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "HYDROCORTISONE ACETATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani.",
      "Description": "Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11ß) with the following structural formula. Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable base."
    },
    {
      "NDCCode": "42494-341-12",
      "PackageDescription": "1 BLISTER PACK in 1 BOX (42494-341-12)  / 12 SUPPOSITORY in 1 BLISTER PACK",
      "NDC11Code": "42494-0341-12",
      "ProductNDC": "42494-341",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone Acetate",
      "NonProprietaryName": "Hydrocortisone Acetate",
      "DosageFormName": "SUPPOSITORY",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20220401",
      "EndMarketingDate": "20260430",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals, Limited Liability Company",
      "SubstanceName": "HYDROCORTISONE ACETATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220401",
      "EndMarketingDatePackage": "20260430",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42494-341-24",
      "PackageDescription": "2 BLISTER PACK in 1 BOX (42494-341-24)  / 12 SUPPOSITORY in 1 BLISTER PACK",
      "NDC11Code": "42494-0341-24",
      "ProductNDC": "42494-341",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone Acetate",
      "NonProprietaryName": "Hydrocortisone Acetate",
      "DosageFormName": "SUPPOSITORY",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20220401",
      "EndMarketingDate": "20260430",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals, Limited Liability Company",
      "SubstanceName": "HYDROCORTISONE ACETATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220401",
      "EndMarketingDatePackage": "20260430",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42494-432-30",
      "PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (42494-432-30) ",
      "NDC11Code": "42494-0432-30",
      "ProductNDC": "42494-432",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Multi-vit-flor",
      "NonProprietaryName": "Sodium Fluoride, Vitamin A Acetate, Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Calcium, And Cyanocobalamin",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220202",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": ".ALPHA.-TOCOPHEROL, D-; CHOLECALCIFEROL; CYANOCOBALAMIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE",
      "StrengthNumber": "10; 10; 4.5; 230; 10; 1; 1.2; 60; 1; 1; 600",
      "StrengthUnit": "mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220202",
      "SamplePackage": "N",
      "Description": "Multi-Vit-Flor. (Multivitamin with 0.25 mg, 0.5 mg and 1 mg of Fluoride) Chewable Tablet Multivitamin and Fluoride Supplement. Ingredients: Sucrose, Sorbitol, Fructose, Citric Acid, Beet Root Juice, Carrageenan, Grape Flavor, Raspberry Flavor, Stearic Acid, Cherry Flavor, Magnesium Stearate, Sucralose."
    },
    {
      "NDCCode": "42494-433-30",
      "PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (42494-433-30) ",
      "NDC11Code": "42494-0433-30",
      "ProductNDC": "42494-433",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Multi-vit-flor",
      "NonProprietaryName": "Sodium Fluoride, Vitamin A Acetate, Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Calcium, And Cyanocobalamin",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220202",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": ".ALPHA.-TOCOPHEROL, D-; CHOLECALCIFEROL; CYANOCOBALAMIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE",
      "StrengthNumber": "10; 10; 4.5; 230; 10; 1; 1.2; 60; .5; 1; 600",
      "StrengthUnit": "mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220202",
      "SamplePackage": "N",
      "Description": "Multi-Vit-Flor. (Multivitamin with 0.25 mg, 0.5 mg and 1 mg of Fluoride) Chewable Tablet Multivitamin and Fluoride Supplement. Ingredients: Sucrose, Sorbitol, Fructose, Citric Acid, Beet Root Juice, Carrageenan, Grape Flavor, Raspberry Flavor, Stearic Acid, Cherry Flavor, Magnesium Stearate, Sucralose."
    },
    {
      "NDCCode": "42494-434-30",
      "PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (42494-434-30) ",
      "NDC11Code": "42494-0434-30",
      "ProductNDC": "42494-434",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Multi-vit-flor",
      "NonProprietaryName": "Sodium Fluoride, Vitamin A Acetate, Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Calcium, And Cyanocobalamin",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220202",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": ".ALPHA.-TOCOPHEROL, D-; CHOLECALCIFEROL; CYANOCOBALAMIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE",
      "StrengthNumber": "10; 10; 4.5; 230; 10; 1; 1.2; 60; .25; 1; 600",
      "StrengthUnit": "mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220202",
      "SamplePackage": "N",
      "Description": "Multi-Vit-Flor. (Multivitamin with 0.25 mg, 0.5 mg and 1 mg of Fluoride) Chewable Tablet Multivitamin and Fluoride Supplement. Ingredients: Sucrose, Sorbitol, Fructose, Citric Acid, Beet Root Juice, Carrageenan, Grape Flavor, Raspberry Flavor, Stearic Acid, Cherry Flavor, Magnesium Stearate, Sucralose."
    },
    {
      "NDCCode": "42494-457-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (42494-457-30) ",
      "NDC11Code": "42494-0457-30",
      "ProductNDC": "42494-457",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Entecavir",
      "NonProprietaryName": "Entecavir Anhydrous",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250515",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216857",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "ENTECAVIR ANHYDROUS",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.",
      "Description": "Entecavir is a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3- (hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one, monohydrate. Its molecular formula is C12H15N5O3∙H2O, which corresponds to a molecular weight of 295.3. Entecavir has the following structural formula. Entecavir is a white to off-white powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25 °C ± 0.5 °C. Entecavir film-coated tablets are available for oral administration in strengths of 0.5 mg and 1 mg of entecavir. Entecavir 0.5 mg and 1 mg film-coated tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet coating contains titanium dioxide, hypromellose, polyethylene glycol 400, polysorbate 80 (0.5 mg tablet only), and iron oxide red (1 mg tablet only). FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "42494-458-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (42494-458-30) ",
      "NDC11Code": "42494-0458-30",
      "ProductNDC": "42494-458",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Entecavir",
      "NonProprietaryName": "Entecavir Anhydrous",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250515",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216857",
      "LabelerName": "Cameron Pharmaceuticals",
      "SubstanceName": "ENTECAVIR ANHYDROUS",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.",
      "Description": "Entecavir is a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3- (hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one, monohydrate. Its molecular formula is C12H15N5O3∙H2O, which corresponds to a molecular weight of 295.3. Entecavir has the following structural formula. Entecavir is a white to off-white powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25 °C ± 0.5 °C. Entecavir film-coated tablets are available for oral administration in strengths of 0.5 mg and 1 mg of entecavir. Entecavir 0.5 mg and 1 mg film-coated tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet coating contains titanium dioxide, hypromellose, polyethylene glycol 400, polysorbate 80 (0.5 mg tablet only), and iron oxide red (1 mg tablet only). FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "0143-9747-25",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BLISTER PACK (0143-9747-25) ",
      "NDC11Code": "00143-9747-25",
      "ProductNDC": "0143-9747",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Donepezil Hydrochloride",
      "NonProprietaryName": "Donepezil Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110528",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090247",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "DONEPEZIL HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20110528",
      "SamplePackage": "N",
      "IndicationAndUsage": "Donepezil hydrochloride tablets are an acetylcholinase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease (1.0).",
      "Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrate and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5, or 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate. The film coating contains talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent."
    },
    {
      "NDCCode": "0143-9748-25",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BLISTER PACK (0143-9748-25) ",
      "NDC11Code": "00143-9748-25",
      "ProductNDC": "0143-9748",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Donepezil Hydrochloride",
      "NonProprietaryName": "Donepezil Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110528",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090247",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "DONEPEZIL HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20110528",
      "SamplePackage": "N",
      "IndicationAndUsage": "Donepezil hydrochloride tablets are an acetylcholinase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease (1.0).",
      "Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrate and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5, or 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate. The film coating contains talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent."
    },
    {
      "NDCCode": "0169-7901-01",
      "PackageDescription": "1 KIT in 1 KIT (0169-7901-01)  *  4 mL in 1 VIAL, GLASS (0169-7911-90)  *  4 mL in 1 SYRINGE, GLASS (0169-7009-98)  *  4 mL in 1 VIAL, GLASS (0169-7911-11) ",
      "NDC11Code": "00169-7901-01",
      "ProductNDC": "0169-7901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebinyn",
      "NonProprietaryName": "Coagulation Factor Ix Recombinant, Glycopegylated",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20171201",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125611",
      "LabelerName": "Novo Nordisk",
      "Status": "Active",
      "LastUpdate": "2024-08-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171201",
      "SamplePackage": "N",
      "IndicationAndUsage": "REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
      "Description": "REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN."
    },
    {
      "NDCCode": "0169-7901-97",
      "PackageDescription": "1 KIT in 1 KIT (0169-7901-97)  *  4 mL in 1 VIAL, GLASS (0169-7911-90)  *  4 mL in 1 SYRINGE, GLASS (0169-7009-98)  *  4 mL in 1 VIAL, GLASS (0169-7911-11) ",
      "NDC11Code": "00169-7901-97",
      "ProductNDC": "0169-7901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebinyn",
      "NonProprietaryName": "Coagulation Factor Ix Recombinant, Glycopegylated",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20171201",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125611",
      "LabelerName": "Novo Nordisk",
      "Status": "Active",
      "LastUpdate": "2024-08-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220505",
      "SamplePackage": "Y",
      "IndicationAndUsage": "REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
      "Description": "REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN."
    },
    {
      "NDCCode": "0169-7902-01",
      "PackageDescription": "1 KIT in 1 KIT (0169-7902-01)  *  4 mL in 1 VIAL, GLASS (0169-7922-90)  *  4 mL in 1 SYRINGE, GLASS (0169-7009-98)  *  4 mL in 1 VIAL, GLASS (0169-7922-11) ",
      "NDC11Code": "00169-7902-01",
      "ProductNDC": "0169-7902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebinyn",
      "NonProprietaryName": "Coagulation Factor Ix Recombinant, Glycopegylated",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20171201",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125611",
      "LabelerName": "Novo Nordisk",
      "Status": "Active",
      "LastUpdate": "2024-08-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171201",
      "SamplePackage": "N",
      "IndicationAndUsage": "REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
      "Description": "REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN."
    },
    {
      "NDCCode": "0169-7902-97",
      "PackageDescription": "1 KIT in 1 KIT (0169-7902-97)  *  4 mL in 1 VIAL, GLASS (0169-7922-90)  *  4 mL in 1 SYRINGE, GLASS (0169-7009-98)  *  4 mL in 1 VIAL, GLASS (0169-7922-11) ",
      "NDC11Code": "00169-7902-97",
      "ProductNDC": "0169-7902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebinyn",
      "NonProprietaryName": "Coagulation Factor Ix Recombinant, Glycopegylated",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20171201",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125611",
      "LabelerName": "Novo Nordisk",
      "Status": "Active",
      "LastUpdate": "2024-08-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220505",
      "SamplePackage": "Y",
      "IndicationAndUsage": "REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
      "Description": "REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN."
    },
    {
      "NDCCode": "0169-7903-01",
      "PackageDescription": "1 KIT in 1 KIT (0169-7903-01)  *  4 mL in 1 VIAL, GLASS (0169-7933-11)  *  4 mL in 1 SYRINGE, GLASS (0169-7009-98) ",
      "NDC11Code": "00169-7903-01",
      "ProductNDC": "0169-7903",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rebinyn",
      "NonProprietaryName": "Coagulation Factor Ix Recombinant, Glycopegylated",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20220811",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125611",
      "LabelerName": "Novo Nordisk",
      "Status": "Active",
      "LastUpdate": "2024-08-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220811",
      "SamplePackage": "N",
      "IndicationAndUsage": "REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
      "Description": "REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless to slightly yellow liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-dose vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU, 2000, or 3000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives. REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 144 IU/mg protein. REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"42494-415-25","ProprietaryName":"Phenobarbital Sodium","NonProprietaryName":"Phenobarbital Sodium"},{"NDCCode":"42494-415-03","ProprietaryName":"Phenobarbital Sodium","NonProprietaryName":"Phenobarbital Sodium"},{"NDCCode":"42494-416-25","ProprietaryName":"Phenobarbital Sodium","NonProprietaryName":"Phenobarbital Sodium"},{"NDCCode":"42494-435-25","ProprietaryName":"Acetylcysteine","NonProprietaryName":"Acetylcysteine"},{"NDCCode":"42494-436-25","ProprietaryName":"Acetylcysteine","NonProprietaryName":"Acetylcysteine"},{"NDCCode":"42494-441-25","ProprietaryName":"Phenobarbital Sodium","NonProprietaryName":"Phenobarbital Sodium"},{"NDCCode":"42494-442-25","ProprietaryName":"Phenobarbital Sodium","NonProprietaryName":"Phenobarbital Sodium"},{"NDCCode":"43547-415-25","ProprietaryName":"Lisinopril","NonProprietaryName":"Lisinopril"},{"NDCCode":"59779-415-25","ProprietaryName":"Indoor/outdoor Allergy Relief Softgels","NonProprietaryName":"Cetirizine Hydrochloride"},{"NDCCode":"71288-415-06","ProprietaryName":"Glycopyrrolate","NonProprietaryName":"Glycopyrrolate"},{"NDCCode":"71288-415-96","ProprietaryName":"Glycopyrrolate","NonProprietaryName":"Glycopyrrolate"},{"NDCCode":"72603-415-25","ProprietaryName":"Bupivacaine Hydrochloride","NonProprietaryName":"Bupivacaine Hydrochloride"},{"NDCCode":"42494-119-90","ProprietaryName":"Se-tan Dha","NonProprietaryName":"Ferrous Fumarate And Polysaccharide Iron"},{"NDCCode":"42494-301-01","ProprietaryName":"Hydrocortisone Acetate","NonProprietaryName":"Hydrocortisone Acetate"},{"NDCCode":"42494-301-12","ProprietaryName":"Hydrocortisone Acetate","NonProprietaryName":"Hydrocortisone Acetate"},{"NDCCode":"42494-301-24","ProprietaryName":"Hydrocortisone Acetate","NonProprietaryName":"Hydrocortisone Acetate"},{"NDCCode":"42494-341-12","ProprietaryName":"Hydrocortisone Acetate","NonProprietaryName":"Hydrocortisone Acetate"},{"NDCCode":"42494-341-24","ProprietaryName":"Hydrocortisone Acetate","NonProprietaryName":"Hydrocortisone Acetate"},{"NDCCode":"42494-432-30","ProprietaryName":"Multi-vit-flor","NonProprietaryName":"Sodium Fluoride, Vitamin A Acetate, Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Calcium, And Cyanocobalamin"},{"NDCCode":"42494-433-30","ProprietaryName":"Multi-vit-flor","NonProprietaryName":"Sodium Fluoride, Vitamin A Acetate, Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Calcium, And Cyanocobalamin"},{"NDCCode":"42494-434-30","ProprietaryName":"Multi-vit-flor","NonProprietaryName":"Sodium Fluoride, Vitamin A Acetate, Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Calcium, And Cyanocobalamin"},{"NDCCode":"42494-457-30","ProprietaryName":"Entecavir","NonProprietaryName":"Entecavir Anhydrous"},{"NDCCode":"42494-458-30","ProprietaryName":"Entecavir","NonProprietaryName":"Entecavir Anhydrous"},{"NDCCode":"0143-9747-25","ProprietaryName":"Donepezil Hydrochloride","NonProprietaryName":"Donepezil Hydrochloride"},{"NDCCode":"0143-9748-25","ProprietaryName":"Donepezil Hydrochloride","NonProprietaryName":"Donepezil Hydrochloride"},{"NDCCode":"0169-7901-01","ProprietaryName":"Rebinyn","NonProprietaryName":"Coagulation Factor Ix Recombinant, Glycopegylated"},{"NDCCode":"0169-7901-97","ProprietaryName":"Rebinyn","NonProprietaryName":"Coagulation Factor Ix Recombinant, Glycopegylated"},{"NDCCode":"0169-7902-01","ProprietaryName":"Rebinyn","NonProprietaryName":"Coagulation Factor Ix Recombinant, Glycopegylated"},{"NDCCode":"0169-7902-97","ProprietaryName":"Rebinyn","NonProprietaryName":"Coagulation Factor Ix Recombinant, Glycopegylated"},{"NDCCode":"0169-7903-01","ProprietaryName":"Rebinyn","NonProprietaryName":"Coagulation Factor Ix Recombinant, Glycopegylated"}]}
                    

<NDCList><NDC><NDCCode>42494-415-25</NDCCode><ProprietaryName>Phenobarbital Sodium</ProprietaryName><NonProprietaryName>Phenobarbital Sodium</NonProprietaryName></NDC><NDC><NDCCode>42494-415-03</NDCCode><ProprietaryName>Phenobarbital Sodium</ProprietaryName><NonProprietaryName>Phenobarbital Sodium</NonProprietaryName></NDC><NDC><NDCCode>42494-416-25</NDCCode><ProprietaryName>Phenobarbital Sodium</ProprietaryName><NonProprietaryName>Phenobarbital Sodium</NonProprietaryName></NDC><NDC><NDCCode>42494-435-25</NDCCode><ProprietaryName>Acetylcysteine</ProprietaryName><NonProprietaryName>Acetylcysteine</NonProprietaryName></NDC><NDC><NDCCode>42494-436-25</NDCCode><ProprietaryName>Acetylcysteine</ProprietaryName><NonProprietaryName>Acetylcysteine</NonProprietaryName></NDC><NDC><NDCCode>42494-441-25</NDCCode><ProprietaryName>Phenobarbital Sodium</ProprietaryName><NonProprietaryName>Phenobarbital Sodium</NonProprietaryName></NDC><NDC><NDCCode>42494-442-25</NDCCode><ProprietaryName>Phenobarbital Sodium</ProprietaryName><NonProprietaryName>Phenobarbital Sodium</NonProprietaryName></NDC><NDC><NDCCode>43547-415-25</NDCCode><ProprietaryName>Lisinopril</ProprietaryName><NonProprietaryName>Lisinopril</NonProprietaryName></NDC><NDC><NDCCode>59779-415-25</NDCCode><ProprietaryName>Indoor/outdoor Allergy Relief Softgels</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71288-415-06</NDCCode><ProprietaryName>Glycopyrrolate</ProprietaryName><NonProprietaryName>Glycopyrrolate</NonProprietaryName></NDC><NDC><NDCCode>71288-415-96</NDCCode><ProprietaryName>Glycopyrrolate</ProprietaryName><NonProprietaryName>Glycopyrrolate</NonProprietaryName></NDC><NDC><NDCCode>72603-415-25</NDCCode><ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42494-119-90</NDCCode><ProprietaryName>Se-tan Dha</ProprietaryName><NonProprietaryName>Ferrous Fumarate And Polysaccharide Iron</NonProprietaryName></NDC><NDC><NDCCode>42494-301-01</NDCCode><ProprietaryName>Hydrocortisone Acetate</ProprietaryName><NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName></NDC><NDC><NDCCode>42494-301-12</NDCCode><ProprietaryName>Hydrocortisone Acetate</ProprietaryName><NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName></NDC><NDC><NDCCode>42494-301-24</NDCCode><ProprietaryName>Hydrocortisone Acetate</ProprietaryName><NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName></NDC><NDC><NDCCode>42494-341-12</NDCCode><ProprietaryName>Hydrocortisone Acetate</ProprietaryName><NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName></NDC><NDC><NDCCode>42494-341-24</NDCCode><ProprietaryName>Hydrocortisone Acetate</ProprietaryName><NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName></NDC><NDC><NDCCode>42494-432-30</NDCCode><ProprietaryName>Multi-vit-flor</ProprietaryName><NonProprietaryName>Sodium Fluoride, Vitamin A Acetate, Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Calcium, And Cyanocobalamin</NonProprietaryName></NDC><NDC><NDCCode>42494-433-30</NDCCode><ProprietaryName>Multi-vit-flor</ProprietaryName><NonProprietaryName>Sodium Fluoride, Vitamin A Acetate, Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Calcium, And Cyanocobalamin</NonProprietaryName></NDC><NDC><NDCCode>42494-434-30</NDCCode><ProprietaryName>Multi-vit-flor</ProprietaryName><NonProprietaryName>Sodium Fluoride, Vitamin A Acetate, Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Calcium, And Cyanocobalamin</NonProprietaryName></NDC><NDC><NDCCode>42494-457-30</NDCCode><ProprietaryName>Entecavir</ProprietaryName><NonProprietaryName>Entecavir Anhydrous</NonProprietaryName></NDC><NDC><NDCCode>42494-458-30</NDCCode><ProprietaryName>Entecavir</ProprietaryName><NonProprietaryName>Entecavir Anhydrous</NonProprietaryName></NDC><NDC><NDCCode>0143-9747-25</NDCCode><ProprietaryName>Donepezil Hydrochloride</ProprietaryName><NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0143-9748-25</NDCCode><ProprietaryName>Donepezil Hydrochloride</ProprietaryName><NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0169-7901-01</NDCCode><ProprietaryName>Rebinyn</ProprietaryName><NonProprietaryName>Coagulation Factor Ix Recombinant, Glycopegylated</NonProprietaryName></NDC><NDC><NDCCode>0169-7901-97</NDCCode><ProprietaryName>Rebinyn</ProprietaryName><NonProprietaryName>Coagulation Factor Ix Recombinant, Glycopegylated</NonProprietaryName></NDC><NDC><NDCCode>0169-7902-01</NDCCode><ProprietaryName>Rebinyn</ProprietaryName><NonProprietaryName>Coagulation Factor Ix Recombinant, Glycopegylated</NonProprietaryName></NDC><NDC><NDCCode>0169-7902-97</NDCCode><ProprietaryName>Rebinyn</ProprietaryName><NonProprietaryName>Coagulation Factor Ix Recombinant, Glycopegylated</NonProprietaryName></NDC><NDC><NDCCode>0169-7903-01</NDCCode><ProprietaryName>Rebinyn</ProprietaryName><NonProprietaryName>Coagulation Factor Ix Recombinant, Glycopegylated</NonProprietaryName></NDC></NDCList>