RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "57353-106-53",
      "PackageDescription": "1 TUBE in 1 BOX (57353-106-53)  > 113 g in 1 TUBE (57353-106-13) ",
      "NDC11Code": "57353-0106-53",
      "ProductNDC": "57353-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Luster Power White",
      "ProprietaryNameSuffix": "Deep Stain Eraser",
      "NonProprietaryName": "Sodium Monofluorophosphate",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "DENTOVATIONS INC",
      "SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
      "StrengthNumber": ".88",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20121201",
      "SamplePackage": "N",
      "IndicationAndUsage": "USE: Helps protect against cavities."
    },
    {
      "NDCCode": "57353-101-53",
      "PackageDescription": "1 TUBE in 1 BOX (57353-101-53)  > 74 g in 1 TUBE (57353-101-13)",
      "NDC11Code": "57353-0101-53",
      "ProductNDC": "57353-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Power White 7",
      "ProprietaryNameSuffix": "Sensitive",
      "NonProprietaryName": "Sodium Fluoride Potassium Nitrate",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20121201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "DENTOVATIONS INC",
      "SubstanceName": "SODIUM FLUORIDE; POTASSIUM NITRATE",
      "StrengthNumber": ".24; 5",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "57353-102-63",
      "PackageDescription": "2 BOX in 1 BOX (57353-102-63)  > 1 TUBE in 1 BOX (57353-102-53)  > 74 g in 1 TUBE (57353-102-13)",
      "NDC11Code": "57353-0102-63",
      "ProductNDC": "57353-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Power White 7",
      "ProprietaryNameSuffix": "Everyday Whitening",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20121201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "DENTOVATIONS INC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".24",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "57353-103-53",
      "PackageDescription": "1 TUBE in 1 BOX (57353-103-53)  > 113 g in 1 TUBE (57353-103-13) ",
      "NDC11Code": "57353-0103-53",
      "ProductNDC": "57353-103",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Luster Now",
      "ProprietaryNameSuffix": "Instant Whitening",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20121201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "DENTOVATIONS INC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".24",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20160620",
      "SamplePackage": "N",
      "IndicationAndUsage": "USES: ANTI-CAVITY."
    },
    {
      "NDCCode": "55319-106-53",
      "PackageDescription": "12 BLISTER PACK in 1 CARTON (55319-106-53)  > 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "55319-0106-53",
      "ProductNDC": "55319-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Family Wellness Anti Diarrheal Plus Multi Symptom Relief",
      "NonProprietaryName": "Loperamide Hydrochloride, Simethicone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200319",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209837",
      "LabelerName": "Family Dollar Services Inc",
      "SubstanceName": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "125; 2",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200319",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58503-106-01",
      "PackageDescription": "53 mL in 1 BOTTLE (58503-106-01) ",
      "NDC11Code": "58503-0106-01",
      "ProductNDC": "58503-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer W Travel Clip 1.8 Oz",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20171128",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "China Ningbo Shangge Cosmetic Technology Corp.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20171128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Assured. Instant Hand Sanitizer. Kills 99% of germs!. Aloe Vera & Moisturizers. Compare to Active Ingredients in Purell® Hand Sanitizer*. Special Value 25% more free. 10 fl oz / 295 ml. *This product is not manufactured or distributed by Gojo Industries Inc, distributor of the registered trademark Purell."
    },
    {
      "NDCCode": "67544-106-53",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (67544-106-53)",
      "NDC11Code": "67544-0106-53",
      "ProductNDC": "67544-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lovastatin",
      "NonProprietaryName": "Lovastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20011217",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075636",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "LOVASTATIN",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-11",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "71610-106-53",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71610-106-53) ",
      "NDC11Code": "71610-0106-53",
      "ProductNDC": "71610-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077206",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180730",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
      "Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride 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 C17H17NCl2HCl 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 are supplied for oral administration as scored tablets containing sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
    },
    {
      "NDCCode": "84165-106-53",
      "PackageDescription": "53 BAG in 1 BOX (84165-106-53)  / 11 g in 1 BAG (84165-106-01) ",
      "NDC11Code": "84165-0106-53",
      "ProductNDC": "84165-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lidocaine Pain Relief Gel-patch",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250109",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Guangzhou Zhupuyou E-commerce Co., Ltd",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": ".04",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-01-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders.elbows."
    },
    {
      "NDCCode": "14537-408-50",
      "PackageDescription": "18 CONTAINER in 1 CASE (14537-408-50)  / 500 mL in 1 CONTAINER",
      "NDC11Code": "14537-0408-50",
      "ProductNDC": "14537-408",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isoplate",
      "NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130305",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN090067",
      "LabelerName": "Terumo BCT Ltd.",
      "SubstanceName": "MAGNESIUM CHLORIDE; MONOBASIC POTASSIUM PHOSPHATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM",
      "StrengthNumber": ".03; .00082; .037; .37; .53; .5; .008",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130305",
      "SamplePackage": "N",
      "IndicationAndUsage": "ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution to replace a portion of the plasma to store Platelets Pheresis Platelet Additive Solution (PAS) Added Leukocytes Reduced products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system [See Dosage and Administration (2).]. Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% ISOPLATE SOLUTION and 35% plasma. Platelets in the solution can be stored at a concentration range of 0.7 to 2.1 × 106/µL for up to 5 days at 20-24 °C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)] [See Clinical Studies (14).].",
      "Description": "ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution designed to replace a proportion of the plasma used in the storage of Platelet Pheresis, Leukocytes Reduced PAS products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system. The solution is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ISOPLATE SOLUTION contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g; Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 g; Dibasic Sodium Phosphate Dihydrate USP 0.008 g; Monobasic Potassium Phosphate NF 0.00082 g; in Water for Injection USP. pH may be adjusted with glacial Acetic Acid USP or Sodium Hydroxide NF pH: 7.4 (7.0-7.8). Concentration of Electrolytes (mEq/liter): Sodium 141; Potassium 5; Magnesium 3; Chloride 98; Phosphate (HPO=4 ) 1 (0.5 mmole P/liter); Acetate (CH3COO–) 27; Gluconate (HOCH2(CHOH)4COO–) 23. The polyolefin bag is not made with natural rubber latex or PVC. Di(2-ethylhexyl)phthalate (DEHP) is present only in sterile dock tube. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The solution contact layer is an elasticized polyolefin. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary."
    },
    {
      "NDCCode": "24689-106-01",
      "PackageDescription": "473 mL in 1 BOTTLE (24689-106-01) ",
      "NDC11Code": "24689-0106-01",
      "ProductNDC": "24689-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078582",
      "LabelerName": "APNAR PHARMA LP",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240601",
      "SamplePackage": "N",
      "Description": "Levetiracetam Oral Solution, USP is an antiepileptic drug available as a clear, colorless, cherry-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1- pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21 g/mol. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam 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 Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: cherry flavor (imitation), citric acid monohydrate, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, sorbitol solution, purified water and sucralose."
    },
    {
      "NDCCode": "69102-106-01",
      "PackageDescription": "120 TABLET in 1 BOTTLE (69102-106-01) ",
      "NDC11Code": "69102-0106-01",
      "ProductNDC": "69102-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201028",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078858",
      "LabelerName": "OWP Pharmaceuticals, Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-05-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201028",
      "SamplePackage": "N",
      "IndicationAndUsage": "Roweepra (levetiracetam) is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Roweepra (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": "Roweepra (levetiracetam USP) is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets. The chemical name of levetiracetam, USP, 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, USP 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 (104.0 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.). Roweepra (levetiracetam USP) tablets, contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below:250 mg tablets: FD&C Blue #2 Lake of indigo carmine500 mg tablets: Ferric oxide yellow780 mg tablets: Ferric oxide red and FD&C #6 lake of sunset yellow. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "69639-106-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (69639-106-01)  / 20 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "69639-0106-01",
      "ProductNDC": "69639-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Akynzeo",
      "NonProprietaryName": "Fosnetupitant And Palonosetron",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230801",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210493",
      "LabelerName": "Helsinn Therapeutics (U.S.), Inc.",
      "SubstanceName": "FOSNETUPITANT; PALONOSETRON HYDROCHLORIDE",
      "StrengthNumber": "260; .28",
      "StrengthUnit": "mg/20mL; mg/20mL",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230801",
      "SamplePackage": "N",
      "IndicationAndUsage": "AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.  Limitations of Use  AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.",
      "Description": "AKYNZEO (300 mg netupitant/0.5 mg palonosetron) capsules are an oral combination product of netupitant, a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron hydrochloride, a serotonin-3 (5-HT3) receptor antagonist. Both netupitant and palonosetron hydrochloride are anti-nausea and anti-emetic agents. Netupitant is chemically described: 2-[3,5-bis(trifluoromethyl)phenyl]-N, 2 dimethyl-N-[4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl] propanamide. The empirical formula is C30H32F6N4O, with a molecular weight of 578.61. Netupitant exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is chemically described: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Netupitant is white to off-white crystalline powder. It is freely soluble in toluene and acetone, soluble in isopropanol and ethanol, and very slightly soluble in water. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Each AKYNZEO capsule is composed of one white-caramel hard gelatin capsule which contains three tablets each containing 100 mg netupitant and one gelatin capsule containing 0.5 mg palonosetron (equivalent to 0.56 mg palonosetron hydrochloride). The inactive ingredients are butylated hydroxyanisole (BHA), croscarmellose sodium, gelatin, glycerin, magnesium stearate, microcrystalline cellulose, mono- and di-glycerides of capryl/capric acid, polyglyceryl dioleate, povidone K-30, purified water, red iron oxide, silicon dioxide, sodium stearyl fumarate, sorbitol, sucrose fatty acid esters, titanium dioxide and yellow iron oxide. It may contain traces of medium-chain triglycerides, lecithin, and denatured ethanol. AKYNZEO (235 mg fosnetupitant/0.25 mg palonosetron) for injection is a combination product of fosnetupitant, a prodrug of netupitant, which is a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron hydrochloride, a serotonin-3 (5-HT3) receptor antagonist. Fosnetupitant chloride hydrochloride is chemically described as 2-(3,5-bis-trifluoromethylphenyl)-N-methyl-N-[6-(4-methyl-4-O-methylene-phosphatepiperazinium-1-yl)-4-o-tolyl-pyridin-3-yl]-isobutyramide chloride hydrochloride. The empirical formula is C31H36F6N4O5PClHCl, with a molecular weight of 761.53. Fosnetupitant chloride hydrochloride exists as a single isomer and has the following structural formula. Fosnetupitant chloride hydrochloride is white to off-white to yellowish solid or powder. Its solubility is pH dependent: at acidic pH (pH 2), its solubility is 1.4 mg/mL; at basic pH (pH 10), its solubility is 11.5 mg/mL. Palonosetron hydrochloride is described above in this section. AKYNZEO for injection is available for intravenous infusion supplied as a sterile lyophilized powder. Each vial of AKYNZEO for injection contains 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride). The inactive ingredients are edetate disodium (6.4 mg), mannitol (760 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment). AKYNZEO injection is available for intravenous infusion supplied as a sterile solution in a single-dose vial. Each vial of AKYNZEO injection contains 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride). The inactive ingredients are edetate disodium (3.2 mg), mannitol (760 mg), water for injection, sodium hydroxide and/or hydrochloric acid (for pH adjustment)."
    },
    {
      "NDCCode": "72485-106-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (72485-106-10)  / 5 mL in 1 VIAL, SINGLE-DOSE (72485-106-01) ",
      "NDC11Code": "72485-0106-10",
      "ProductNDC": "72485-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211954",
      "LabelerName": "Armas Pharmaceuticals Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2023-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) . Levetiracetam injection is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) . Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible (  1.4) .",
      "Description": "Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous 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 is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 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 injection, USP contains 100 mg of levetiracetam per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection, USP must be diluted prior to intravenous infusion [ see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "72485-106-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (72485-106-25)  / 5 mL in 1 VIAL, SINGLE-DOSE (72485-106-01) ",
      "NDC11Code": "72485-0106-25",
      "ProductNDC": "72485-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211954",
      "LabelerName": "Armas Pharmaceuticals Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2023-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230316",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) . Levetiracetam injection is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) . Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible (  1.4) .",
      "Description": "Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous 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 is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 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 injection, USP contains 100 mg of levetiracetam per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection, USP must be diluted prior to intravenous infusion [ see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "57353-103-31",
      "PackageDescription": "3 TUBE in 1 BOX (57353-103-31)  > 42 g in 1 TUBE (57353-103-11) ",
      "NDC11Code": "57353-0103-31",
      "ProductNDC": "57353-103",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Luster Now",
      "ProprietaryNameSuffix": "Instant Whitening",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20121201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "DENTOVATIONS INC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".24",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-08-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20160620",
      "SamplePackage": "N",
      "IndicationAndUsage": "USES: ANTI-CAVITY."
    },
    {
      "NDCCode": "57353-104-24",
      "PackageDescription": "1 TUBE in 1 BOX (57353-104-24)  > 113 g in 1 TUBE (57353-104-14)",
      "NDC11Code": "57353-0104-24",
      "ProductNDC": "57353-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Power White",
      "ProprietaryNameSuffix": "Deep Stain Eraser",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20121201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "DENTOVATIONS INC",
      "SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
      "StrengthNumber": ".88",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "57353-105-52",
      "PackageDescription": "1 TUBE in 1 BOX (57353-105-52)  > 45 g in 1 TUBE (57353-105-12) ",
      "NDC11Code": "57353-0105-52",
      "ProductNDC": "57353-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Electrifying Blue Polish",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20150122",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "DENTOVATIONS INC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".24",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20150122",
      "SamplePackage": "N",
      "IndicationAndUsage": "USES: ANTI-CAVITY."
    },
    {
      "NDCCode": "0069-6002-01",
      "PackageDescription": "20 mL in 1 BOTTLE, GLASS (0069-6002-01) ",
      "NDC11Code": "00069-6002-01",
      "ProductNDC": "0069-6002",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Octagam Immune Globulin (human)",
      "NonProprietaryName": "Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125062",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
      "Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
    },
    {
      "NDCCode": "0069-6002-02",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0069-6002-02)  / 20 mL in 1 BOTTLE, GLASS (0069-6002-01) ",
      "NDC11Code": "00069-6002-02",
      "ProductNDC": "0069-6002",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Octagam Immune Globulin (human)",
      "NonProprietaryName": "Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125062",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
      "Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
    },
    {
      "NDCCode": "0069-6111-01",
      "PackageDescription": "100 mL in 1 BOTTLE, GLASS (0069-6111-01) ",
      "NDC11Code": "00069-6111-01",
      "ProductNDC": "0069-6111",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Octagam Immune Globulin (human)",
      "NonProprietaryName": "Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125062",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
      "Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
    },
    {
      "NDCCode": "0069-6111-02",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0069-6111-02)  / 100 mL in 1 BOTTLE, GLASS (0069-6111-01) ",
      "NDC11Code": "00069-6111-02",
      "ProductNDC": "0069-6111",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Octagam Immune Globulin (human)",
      "NonProprietaryName": "Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125062",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
      "Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
    },
    {
      "NDCCode": "0069-6237-01",
      "PackageDescription": "200 mL in 1 BOTTLE, GLASS (0069-6237-01) ",
      "NDC11Code": "00069-6237-01",
      "ProductNDC": "0069-6237",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Octagam Immune Globulin (human)",
      "NonProprietaryName": "Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125062",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
      "Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
    },
    {
      "NDCCode": "0069-6237-02",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0069-6237-02)  / 200 mL in 1 BOTTLE, GLASS (0069-6237-01) ",
      "NDC11Code": "00069-6237-02",
      "ProductNDC": "0069-6237",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Octagam Immune Globulin (human)",
      "NonProprietaryName": "Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125062",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
      "Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
    },
    {
      "NDCCode": "0069-6339-01",
      "PackageDescription": "300 mL in 1 BOTTLE, GLASS (0069-6339-01) ",
      "NDC11Code": "00069-6339-01",
      "ProductNDC": "0069-6339",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Octagam Immune Globulin (human)",
      "NonProprietaryName": "Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125062",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
      "Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
    },
    {
      "NDCCode": "0069-6339-02",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0069-6339-02)  / 300 mL in 1 BOTTLE, GLASS (0069-6339-01) ",
      "NDC11Code": "00069-6339-02",
      "ProductNDC": "0069-6339",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Octagam Immune Globulin (human)",
      "NonProprietaryName": "Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125062",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
      "Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
    },
    {
      "NDCCode": "0069-6550-01",
      "PackageDescription": "50 mL in 1 BOTTLE, GLASS (0069-6550-01) ",
      "NDC11Code": "00069-6550-01",
      "ProductNDC": "0069-6550",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Octagam Immune Globulin (human)",
      "NonProprietaryName": "Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125062",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
      "Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
    },
    {
      "NDCCode": "0069-6550-02",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0069-6550-02)  / 50 mL in 1 BOTTLE, GLASS (0069-6550-01) ",
      "NDC11Code": "00069-6550-02",
      "ProductNDC": "0069-6550",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Octagam Immune Globulin (human)",
      "NonProprietaryName": "Immune Globulin",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231113",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125062",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of. Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 ). Dermatomyositis (DM) in adults ( 1.2 ).",
      "Description": "Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg. The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%. Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 6). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6: In vitro reduction factor during Octagam 10% manufacturing. *not calculated for global LRF. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus. SBV: Sindbis Virus. MEV: Mouse Encephalomyelitis Virus. PPV: Porcine Parvovirus."
    },
    {
      "NDCCode": "0078-0846-19",
      "PackageDescription": "1 INJECTION, SUSPENSION in 1 BAG (0078-0846-19) ",
      "NDC11Code": "00078-0846-19",
      "ProductNDC": "0078-0846",
      "ProductTypeName": "CELLULAR THERAPY",
      "ProprietaryName": "Kymriah",
      "NonProprietaryName": "Tisagenlecleucel",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170830",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125646",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "TISAGENLECLEUCEL",
      "StrengthNumber": "2000000",
      "StrengthUnit": "1/1",
      "Pharm_Classes": "CD19 Receptor Interactions [MoA], CD19-directed Chimeric Antigen Receptor [EPC], CD19-specific Chimeric Antigen Receptor [CS], Genetically-modified Autologous T Cells [EPC], Increased T Lymphocyte Activation [PE], T Lymphocytes, Cultured, Autologous, Genetically-modified [EXT]",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170830",
      "SamplePackage": "N",
      "IndicationAndUsage": "KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: 1 Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. (1.1) , 2 Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.Limitations of Use: KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma. (1.2), 3 Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.3) .",
      "Description": "KYMRIAH (tisagenlecleucel) is a CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells that are genetically modified using a lentiviral vector to encode an anti-CD19 chimeric antigen receptor (CAR). The CAR is comprised of a murine single-chain antibody fragment (scFv) specific for CD19, followed by a CD8 hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB (CD137) and CD3 zeta. KYMRIAH is prepared from the patient’s peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells, then transduced with the lentiviral vector containing the anti-CD19 CAR transgene and activated with anti-CD3/CD28 antibody coated beads. The transduced T cells are expanded in cell culture, washed, and formulated into a suspension, which then is cryopreserved. The product must pass a sterility test before release for shipping as a frozen suspension in a patient-specific infusion bag(s). The product is thawed prior to administration [see Dosage and Administration (2.2), How Supplied/Storage and Handling (16)]. The thawed product is a colorless to slightly yellow suspension of cells. In addition to T cells, other cell populations, including monocytes, NK cells, and B cells, may be present. The formulation contains 31.25% (v/v) of Plasma-Lyte A, 31.25% (v/v) of 5% Dextrose/0.45% sodium chloride, 10% Dextran 40 (LMD)/5% Dextrose, 20% (v/v) of 25% Human Serum Albumin (HSA), and 7.5% (v/v) dimethyl sulfoxide (DMSO). Pediatric and Young Adult r/r B-cell ALL: A single dose of KYMRIAH may contain up to 2.5 x 108 CAR-positive viable T cells provided in one to three patient-specific infusion bag(s). Based on the patient’s weight reported at the time of leukapheresis, one of two possible dose ranges will be prepared for the patient: 1 For patients 50 kg or less: 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight. , 2 For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T cells."
    },
    {
      "NDCCode": "0078-0958-19",
      "PackageDescription": "1 INJECTION, SUSPENSION in 1 BAG (0078-0958-19) ",
      "NDC11Code": "00078-0958-19",
      "ProductNDC": "0078-0958",
      "ProductTypeName": "CELLULAR THERAPY",
      "ProprietaryName": "Kymriah",
      "NonProprietaryName": "Tisagenlecleucel",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180501",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125646",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "TISAGENLECLEUCEL",
      "StrengthNumber": "60000000",
      "StrengthUnit": "1/1",
      "Pharm_Classes": "CD19 Receptor Interactions [MoA], CD19-directed Chimeric Antigen Receptor [EPC], CD19-specific Chimeric Antigen Receptor [CS], Genetically-modified Autologous T Cells [EPC], Increased T Lymphocyte Activation [PE], T Lymphocytes, Cultured, Autologous, Genetically-modified [EXT]",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180501",
      "SamplePackage": "N",
      "IndicationAndUsage": "KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: 1 Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. (1.1) , 2 Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.Limitations of Use: KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma. (1.2), 3 Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.3) .",
      "Description": "KYMRIAH (tisagenlecleucel) is a CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells that are genetically modified using a lentiviral vector to encode an anti-CD19 chimeric antigen receptor (CAR). The CAR is comprised of a murine single-chain antibody fragment (scFv) specific for CD19, followed by a CD8 hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB (CD137) and CD3 zeta. KYMRIAH is prepared from the patient’s peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells, then transduced with the lentiviral vector containing the anti-CD19 CAR transgene and activated with anti-CD3/CD28 antibody coated beads. The transduced T cells are expanded in cell culture, washed, and formulated into a suspension, which then is cryopreserved. The product must pass a sterility test before release for shipping as a frozen suspension in a patient-specific infusion bag(s). The product is thawed prior to administration [see Dosage and Administration (2.2), How Supplied/Storage and Handling (16)]. The thawed product is a colorless to slightly yellow suspension of cells. In addition to T cells, other cell populations, including monocytes, NK cells, and B cells, may be present. The formulation contains 31.25% (v/v) of Plasma-Lyte A, 31.25% (v/v) of 5% Dextrose/0.45% sodium chloride, 10% Dextran 40 (LMD)/5% Dextrose, 20% (v/v) of 25% Human Serum Albumin (HSA), and 7.5% (v/v) dimethyl sulfoxide (DMSO). Pediatric and Young Adult r/r B-cell ALL: A single dose of KYMRIAH may contain up to 2.5 x 108 CAR-positive viable T cells provided in one to three patient-specific infusion bag(s). Based on the patient’s weight reported at the time of leukapheresis, one of two possible dose ranges will be prepared for the patient: 1 For patients 50 kg or less: 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight. , 2 For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T cells."
    }
  ]
}
                    

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