RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "0990-5138-50",
      "PackageDescription": "24 BOTTLE, PLASTIC in 1 CASE (0990-5138-50)  / 500 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00990-5138-50",
      "ProductNDC": "0990-5138",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20240801",
      "EndMarketingDate": "20260501",
      "MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
      "LabelerName": "ICU Medical, Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240801",
      "EndMarketingDatePackage": "20260301",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0990-5138-25",
      "PackageDescription": "24 BOTTLE, PLASTIC in 1 CASE (0990-5138-25)  / 250 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00990-5138-25",
      "ProductNDC": "0990-5138",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20240801",
      "EndMarketingDate": "20260501",
      "MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
      "LabelerName": "ICU Medical, Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240801",
      "EndMarketingDatePackage": "20260501",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0009-5138-02",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (0009-5138-02) ",
      "NDC11Code": "00009-5138-02",
      "ProductNDC": "0009-5138",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zyvox",
      "NonProprietaryName": "Linezolid",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151012",
      "EndMarketingDate": "20270228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021130",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "LINEZOLID",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20151012",
      "EndMarketingDatePackage": "20270228",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5). Limitations of Use (1.6): 1 ZYVOX is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.",
      "Description": "ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. ZYVOX I.V. Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid anhydrous 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag and 1.7 mEq/100 mL bag). ZYVOX Tablet for oral administration contains 600 mg linezolid as a film-coated compressed tablet. Inactive ingredients are carnauba wax, corn starch, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The sodium (Na+) content is 2.92 mg per 600 mg tablet (0.1 mEq/tablet). ZYVOX for Oral Suspension is supplied as an orange-flavored granule/powder for constitution into a suspension for oral administration. Following constitution, each 5 mL contains 100 mg of linezolid. Inactive ingredients are aspartame, citric acid, colloidal silicon dioxide, flavors, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sodium chloride, sodium citrate, sucrose, and xanthan gum [see Patient Counseling Information (17)]. The sodium (Na+) content is 8.52 mg/5 mL (0.4 mEq/5 mL)."
    },
    {
      "NDCCode": "0009-5138-03",
      "PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (0009-5138-03)  / 1 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "00009-5138-03",
      "ProductNDC": "0009-5138",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zyvox",
      "NonProprietaryName": "Linezolid",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151012",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021130",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "LINEZOLID",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20151012",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5). Limitations of Use (1.6): 1 ZYVOX is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.",
      "Description": "ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. ZYVOX I.V. Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid anhydrous 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag and 1.7 mEq/100 mL bag). ZYVOX Tablet for oral administration contains 600 mg linezolid as a film-coated compressed tablet. Inactive ingredients are carnauba wax, corn starch, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The sodium (Na+) content is 2.92 mg per 600 mg tablet (0.1 mEq/tablet). ZYVOX for Oral Suspension is supplied as an orange-flavored granule/powder for constitution into a suspension for oral administration. Following constitution, each 5 mL contains 100 mg of linezolid. Inactive ingredients are aspartame, citric acid, colloidal silicon dioxide, flavors, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sodium chloride, sodium citrate, sucrose, and xanthan gum [see Patient Counseling Information (17)]. The sodium (Na+) content is 8.52 mg/5 mL (0.4 mEq/5 mL)."
    },
    {
      "NDCCode": "50090-5138-0",
      "PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (50090-5138-0)  > 1.5 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "50090-5138-00",
      "ProductNDC": "50090-5138",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ozempic",
      "NonProprietaryName": "Semaglutide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20171206",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209637",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "SEMAGLUTIDE",
      "StrengthNumber": "1.34",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200828",
      "SamplePackage": "N",
      "IndicationAndUsage": "OZEMPIC is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14.4 )].",
      "Description": "OZEMPIC (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol. Structural formula. OZEMPIC is a sterile, aqueous, clear, colorless solution. Each pre-filled pen contains a 1.5 mL solution of OZEMPIC equivalent to 2 mg semaglutide. Each 1 mL of OZEMPIC solution contains 1.34 mg of semaglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14.0 mg; phenol, 5.50 mg; and water for injections. OZEMPIC has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH."
    },
    {
      "NDCCode": "65044-5138-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-5138-5) ",
      "NDC11Code": "65044-5138-05",
      "ProductNDC": "65044-5138",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Molds - Mold Mix 10",
      "NonProprietaryName": "Molds - Mold Mix 10",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19410419",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103888",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; FUSARIUM OXYSPORUM VASINFECTUM; DENDRYPHIELLA VINOSA; CLADOSPORIUM CLADOSPORIOIDES; MUCOR RACEMOSUS; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM GLAUCUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLONOSTACHYS ROSEA F. ROSEA; PHOMA EXIGUA VAR. EXIGUA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER",
      "StrengthNumber": "1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000",
      "StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19410419",
      "SamplePackage": "N",
      "IndicationAndUsage": "Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15. In addition to a carefully taken history, the use of intradermal testing extracts is an accepted method in the diagnosis of allergenic conditions.1, 2, 3 When scratch, prick or puncture reactions are small, or if the patient gives a history of allergic symptoms to a substance but scratch, prick or puncture tests are inconclusive, intradermal tests may be indicated. However, ANTIGENS PRODUCING LARGE 3 TO 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY. Extracts of all allergens do not produce equivalent results in intradermal testing. The intensity of the skin reaction produced will be determined by two factors: the degree of sensitivity of the patient and the nature of the antigenic extract applied. In general, pollen extracts produce whealing reactions, whereas other inhalants produce erythematous reactions with wheals less often. Skin tests to foods seldom produce whealing reactions except for infrequent instances of severe sensitivity to fish, nuts or spices, and rarely other foods.",
      "Description": "Extracts for intradermal testing are supplied in sterile multi-dose vials containing, in addition to the extract allergens and antigens, 0.5% sodium chloride, 0.275% sodium bicarbonate, up to 2% glycerin, 2.5% glycerin for AP products, and, as preservative, 0.4% phenol. The strength of these extracts may be expressed in terms of:. 1. Weight to Volume (w/v) 2. Protein Nitrogen Units/mL (PNU/mL)3. Allergy Units/mL (AU/mL)4. Bioequivalent Allergy Units/mL (BAU/mL)5. Concentrate: 1 Weight to volume (w/v). For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted material will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. In contrast to this, AP (acetone precipitated) extracts, if present, are prepared by reconstituting dry allergenically active concentrates produced by a precipitation process from extracts of raw materials. For those AP extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution., 2 Protein Nitrogen Units per mL (PNU/mL). One protein nitrogen unit represents 0.00001 mg phosphotungstic acid-precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, PNU contents of extracts from different manufacturers are not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract., 3 Allergy Units per mL (AU/mL). The potency of standardized AP and regular extracts labeled in Allergy Units (AU)/mL is determined by in vitro comparison to the reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration., 4 Bioequivalent Allergy Units per mL(BAU/mL). When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method14 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and are labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects., 5 Concentrate. Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength."
    },
    {
      "NDCCode": "0069-0990-50",
      "PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (0069-0990-50)",
      "NDC11Code": "00069-0990-50",
      "ProductNDC": "0069-0990",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vibra-tabs",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19800115",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050533",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2015-05-15"
    },
    {
      "NDCCode": "0990-7075-14",
      "PackageDescription": "24 POUCH in 1 CASE (0990-7075-14)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG",
      "NDC11Code": "00990-7075-14",
      "ProductNDC": "0990-7075",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020161",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "meq/1000mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.",
      "Description": "This Potassium Chloride Injection is a sterile, nonpyrogenic, highly concentrated, ready-to-use solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage. This flexible plastic container is fabricated from a specially formulated polyvinylchloride. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain of its chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials."
    },
    {
      "NDCCode": "0990-7077-14",
      "PackageDescription": "24 POUCH in 1 CASE (0990-7077-14)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG",
      "NDC11Code": "00990-7077-14",
      "ProductNDC": "0990-7077",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020161",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "400",
      "StrengthUnit": "meq/1000mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.",
      "Description": "This Potassium Chloride Injection is a sterile, nonpyrogenic, highly concentrated, ready-to-use solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage. This flexible plastic container is fabricated from a specially formulated polyvinylchloride. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain of its chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials."
    },
    {
      "NDCCode": "0990-7730-36",
      "PackageDescription": "20 POUCH in 1 CASE (0990-7730-36)  / 4 BAG in 1 POUCH / 50 mL in 1 BAG",
      "NDC11Code": "00990-7730-36",
      "ProductNDC": "0990-7730",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018090",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "450",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.",
      "Description": "Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7923-06",
      "PackageDescription": "60 BAG in 1 CASE (0990-7923-06)  > 50 mL in 1 BAG",
      "NDC11Code": "00990-7923-06",
      "ProductNDC": "0990-7923",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose",
      "NonProprietaryName": "Dextrose Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20191001",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016367",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20191001",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0990-7923-13",
      "PackageDescription": "48 POUCH in 1 CASE (0990-7923-13)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG",
      "NDC11Code": "00990-7923-13",
      "ProductNDC": "0990-7923",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose",
      "NonProprietaryName": "Dextrose Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190715",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016367",
      "LabelerName": "ICU Medical, Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
      "Description": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7923-36",
      "PackageDescription": "20 POUCH in 1 CASE (0990-7923-36)  / 4 BAG in 1 POUCH / 50 mL in 1 BAG",
      "NDC11Code": "00990-7923-36",
      "ProductNDC": "0990-7923",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose",
      "NonProprietaryName": "Dextrose Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190715",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016367",
      "LabelerName": "ICU Medical, Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190715",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
      "Description": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7984-06",
      "PackageDescription": "60 BAG in 1 CASE (0990-7984-06)  > 50 mL in 1 BAG",
      "NDC11Code": "00990-7984-06",
      "ProductNDC": "0990-7984",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190815",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016366",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0990-7984-13",
      "PackageDescription": "48 POUCH in 1 CASE (0990-7984-13)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG",
      "NDC11Code": "00990-7984-13",
      "ProductNDC": "0990-7984",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016366",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.",
      "Description": "Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7984-36",
      "PackageDescription": "20 POUCH in 1 CASE (0990-7984-36)  / 4 BAG in 1 POUCH / 50 mL in 1 BAG",
      "NDC11Code": "00990-7984-36",
      "ProductNDC": "0990-7984",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016366",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.",
      "Description": "Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH for both concentrations in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "10117-0990-0",
      "PackageDescription": "50 kg in 1 DRUM (10117-0990-0) ",
      "NDC11Code": "10117-0990-00",
      "ProductNDC": "10117-0990",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sodium Ibuprofen Dihydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20050401",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "BASF Corporation",
      "SubstanceName": "IBUPROFEN SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-11-07",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-APR-05"
    },
    {
      "NDCCode": "40061-990-50",
      "PackageDescription": "50 PACKET in 1 BOX (40061-990-50)  > 8.75 g in 1 PACKET (40061-990-10)",
      "NDC11Code": "40061-0990-50",
      "ProductNDC": "40061-990",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Patricks Sunscreen",
      "NonProprietaryName": "Avobenzone, Octinoxate, Octocrylene, Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110428",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "O.P. Products, Inc.",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "2; 7.25; 9.75; 3",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn . Higher SPF gives more sunburn protection . High protection against sunburn and tanning . Retains SPF after 40 minutes of activity in the water or sweating."
    },
    {
      "NDCCode": "43547-990-50",
      "PackageDescription": "500 TABLET in 1 BOTTLE (43547-990-50) ",
      "NDC11Code": "43547-0990-50",
      "ProductNDC": "43547-990",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tadalafil",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210811",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210608",
      "LabelerName": "Solco Healthcare US, LLC",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-09-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220811",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1).",
      "Description": "Tadalafil, an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as orange, film-coated, almond-shaped tablets for oral administration. Each tablet contains 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, iron oxide yellow, iron oxide red, ferrosoferric oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, polyvinyl alcohol-partially hydrolyzed, macrogol/PEG 3350 and lecithin (soya)."
    },
    {
      "NDCCode": "59779-990-50",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (59779-990-50)  > 25 TABLET, COATED in 1 BLISTER PACK",
      "NDC11Code": "59779-0990-50",
      "ProductNDC": "59779-990",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bisacody",
      "ProprietaryNameSuffix": "Enteric Coated",
      "NonProprietaryName": "Bisacodyl",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130110",
      "EndMarketingDate": "20201231",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "BISACODYL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20130110",
      "EndMarketingDatePackage": "20201231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63029-990-50",
      "PackageDescription": "50 POWDER in 1 CARTON (63029-990-50) ",
      "NDC11Code": "63029-0990-50",
      "ProductNDC": "63029-990",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bc Arthritis",
      "NonProprietaryName": "Aspirin And Caffeine",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Medtech Products Inc.",
      "SubstanceName": "ASPIRIN; CAFFEINE",
      "StrengthNumber": "1000; 65",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120601",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporary relieves minor aches and pains due to:headachesbackacheminor arthritis paincoldsmuscle achestoothache menstrual cramps."
    },
    {
      "NDCCode": "67938-0990-1",
      "PackageDescription": "1 TUBE in 1 BOX (67938-0990-1)  > 50 mL in 1 TUBE (67938-0990-2)",
      "NDC11Code": "67938-0990-01",
      "ProductNDC": "67938-0990",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Prevage Anti Agining Triple Defense Shield Broad Spectrum Sunscreen Spf 50",
      "NonProprietaryName": "Octinoxate, Oxybenzone, Octisalate, Octocrylene, And Avobenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111214",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Elizabeth Arden, Inc",
      "SubstanceName": "OCTINOXATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE; AVOBENZONE",
      "StrengthNumber": "75; 60; 50; 40; 30",
      "StrengthUnit": "mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To Use: Turn brush head to \"On\" and squeeze gently to dispense product. Brush lightly across face. Turn brush head to \"Off\" to store. To clean, rinse brush with warm water and towel dry. Directions For Sunscreen Use:Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m.. Wear long-sleeve shirts, pants, hats, and sunglasses.",
      "Description": "PREVAGE Anti-aging Skincare helps protect and correct skin’s appearance from environmental threats, a leading cause of visible aging signs, for younger-looking, more beautiful skin. This daily defense shield for face with advanced Idebenone technology delivers triple environmental protection against the visible effects of free radical damage due to oxidative stress from sun, pollution and Infrared-A exposure. Provides broad spectrum sun protection from UVA and UVB rays. Helps to correct the appearance of existing sun damage like fine lines, wrinkles, age spots and discolorations and helps prevent future aging signs. Leaves a soft, matte finish and works well under makeup."
    },
    {
      "NDCCode": "71205-990-50",
      "PackageDescription": "50 TABLET in 1 BOTTLE, PLASTIC (71205-990-50) ",
      "NDC11Code": "71205-0990-50",
      "ProductNDC": "71205-990",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pharbetol",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060110",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2024-02-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves minor aches and pains due to: 1 headache, 2 backache, 3 minor pain of arthritis, 4 toothache, 5 muscular aches, 6 menstrual cramps."
    },
    {
      "NDCCode": "0990-4178-03",
      "PackageDescription": "12 BAG in 1 CASE (0990-4178-03)  / 500 mL in 1 BAG",
      "NDC11Code": "00990-4178-03",
      "ProductNDC": "0990-4178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aminosyn-pf",
      "NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20211001",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019398",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; PROLINE; SERINE; TAURINE; TYROSINE",
      "StrengthNumber": "534; 831; 475; 125; 300; 360; 125; 452; 490; 861; 370; 576; 270; 220; 570; 347; 50; 44",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 7% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance. See DOSAGE AND ADMINISTRATION for additional information. Central Venous Infusion. Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants or those requiring long-term parenteral nutrition. Peripheral Parenteral Nutrition. For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5 to 10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.",
      "Description": "Aminosyn®-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn®-PF 7% is oxygen sensitive. The formulation is described below. * Amount cited is for lysine alone and does not include the acetate salt. a From lysine acetate. The formulas for the individual amino acids present in Aminosyn-PF 7% are as follows. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7107-09",
      "PackageDescription": "12 POUCH in 1 CASE (0990-7107-09)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7107-09",
      "ProductNDC": "0990-7107",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride In Dextrose And Sodium Chloride",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200125",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019691",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
      "StrengthNumber": "50; 9; 1.49",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200201",
      "SamplePackage": "N",
      "IndicationAndUsage": "These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.",
      "Description": "Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See Tables for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7109-09",
      "PackageDescription": "12 POUCH in 1 CASE (0990-7109-09)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7109-09",
      "ProductNDC": "0990-7109",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride In Dextrose And Sodium Chloride",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200125",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019691",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
      "StrengthNumber": "50; 9; 2.98",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200125",
      "SamplePackage": "N",
      "IndicationAndUsage": "These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.",
      "Description": "Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See Tables for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7111-09",
      "PackageDescription": "12 POUCH in 1 CASE (0990-7111-09)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7111-09",
      "ProductNDC": "0990-7111",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride In Lactated Ringers And Dextrose",
      "NonProprietaryName": "Potassium Chloride, Sodium Chloride, Calcium Chloride, Sodium Lactate, And Dextrose Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20191125",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019685",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; SODIUM LACTATE; DEXTROSE MONOHYDRATE",
      "StrengthNumber": "1.79; 6; .2; 3.1; 50",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], 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], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191125",
      "SamplePackage": "N",
      "IndicationAndUsage": "This solution is indicated in patients requiring parenteral administration of potassium chloride and the replacement of extracellular losses of fluids and electrolytes with minimal carbohydrate calories.",
      "Description": "Intravenous solution with potassium chloride (I.V. solutions with KCl) is a sterile and nonpyrogenic solution in water for injection. This solution is for administration by intravenous infusion only. See Table for summary of content and characteristics of this solution. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. This solution is a parenteral fluid, nutrient and/or electrolyte replenisher. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Calcium Chloride, USP is chemically designated calcium chloride dihydrate (CaCl2  2H2O), white fragments or granules freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H20. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7901-09",
      "PackageDescription": "12 POUCH in 1 CASE (0990-7901-09)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7901-09",
      "ProductNDC": "0990-7901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride In Dextrose And Sodium Chloride",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018365",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
      "StrengthNumber": "50; 2.25; 1.49",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200201",
      "SamplePackage": "N",
      "IndicationAndUsage": "These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.",
      "Description": "Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See Tables for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7902-03",
      "PackageDescription": "24 POUCH in 1 CASE (0990-7902-03)  / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
      "NDC11Code": "00990-7902-03",
      "ProductNDC": "0990-7902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride In Dextrose And Sodium Chloride",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018362",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
      "StrengthNumber": "50; 4.5; 1.49",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200201",
      "SamplePackage": "N",
      "IndicationAndUsage": "These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.",
      "Description": "Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See Tables for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    },
    {
      "NDCCode": "0990-7902-09",
      "PackageDescription": "12 POUCH in 1 CASE (0990-7902-09)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
      "NDC11Code": "00990-7902-09",
      "ProductNDC": "0990-7902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride In Dextrose And Sodium Chloride",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200201",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018362",
      "LabelerName": "ICU Medical Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
      "StrengthNumber": "50; 4.5; 1.49",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200201",
      "SamplePackage": "N",
      "IndicationAndUsage": "These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.",
      "Description": "Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See Tables for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6  H2O), a hexose sugar freely soluble in water. It has the following structural formula. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
    }
  ]
}
                    

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Hyclate</NonProprietaryName></NDC><NDC><NDCCode>0990-7075-14</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7077-14</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7730-36</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7923-06</NDCCode><ProprietaryName>Dextrose</ProprietaryName><NonProprietaryName>Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0990-7923-13</NDCCode><ProprietaryName>Dextrose</ProprietaryName><NonProprietaryName>Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0990-7923-36</NDCCode><ProprietaryName>Dextrose</ProprietaryName><NonProprietaryName>Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0990-7984-06</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7984-13</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7984-36</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>10117-0990-0</NDCCode><NonProprietaryName>Sodium Ibuprofen Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>40061-990-50</NDCCode><ProprietaryName>Patricks Sunscreen</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, Octocrylene, Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>43547-990-50</NDCCode><ProprietaryName>Tadalafil</ProprietaryName><NonProprietaryName>Tadalafil</NonProprietaryName></NDC><NDC><NDCCode>59779-990-50</NDCCode><ProprietaryName>Bisacody</ProprietaryName><NonProprietaryName>Bisacodyl</NonProprietaryName></NDC><NDC><NDCCode>63029-990-50</NDCCode><ProprietaryName>Bc Arthritis</ProprietaryName><NonProprietaryName>Aspirin And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>67938-0990-1</NDCCode><ProprietaryName>Prevage Anti Agining Triple Defense Shield Broad Spectrum Sunscreen Spf 50</ProprietaryName><NonProprietaryName>Octinoxate, Oxybenzone, Octisalate, Octocrylene, And Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>71205-990-50</NDCCode><ProprietaryName>Pharbetol</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>0990-4178-03</NDCCode><ProprietaryName>Aminosyn-pf</ProprietaryName><NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine</NonProprietaryName></NDC><NDC><NDCCode>0990-7107-09</NDCCode><ProprietaryName>Potassium Chloride In Dextrose And Sodium Chloride</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7109-09</NDCCode><ProprietaryName>Potassium Chloride In Dextrose And Sodium Chloride</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7111-09</NDCCode><ProprietaryName>Potassium Chloride In Lactated Ringers And Dextrose</ProprietaryName><NonProprietaryName>Potassium Chloride, Sodium Chloride, Calcium Chloride, Sodium Lactate, And Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0990-7901-09</NDCCode><ProprietaryName>Potassium Chloride In Dextrose And Sodium Chloride</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7902-03</NDCCode><ProprietaryName>Potassium Chloride In Dextrose And Sodium Chloride</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0990-7902-09</NDCCode><ProprietaryName>Potassium Chloride In Dextrose And Sodium Chloride</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride</NonProprietaryName></NDC></NDCList>