{
"NDC": [
{
"NDCCode": "68462-505-66",
"PackageDescription": "120 g in 1 TUBE (68462-505-66) ",
"NDC11Code": "68462-0505-66",
"ProductNDC": "68462-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091282",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1%is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1) , 2 Avoid use on the face, groin, or axillae. (1.2) , 3 Avoid use in perioral dermatitis or rosacea.",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide USP, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide USP has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is a white powder. It is sparingly soluble in acetone and inchloroform; slightly soluble in alcohol, methanol, dioxane, acetonitrile and ethyl acetate; very slightly soluble inether; and practically insoluble in water. Each gram of fluocinonide cream USP, 0.1%contains 1 mg micronized fluocinonide USP in a cream base of propylene glycol, diethylene glycol monoethyl ether, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate, purified water, carbomer, diisopropanolamine and anhydrous citric acid."
},
{
"NDCCode": "63824-505-26",
"PackageDescription": "1 KIT in 1 CARTON (63824-505-26) * 180 mL in 1 BOTTLE (63824-504-66) * 180 mL in 1 BOTTLE (63824-548-66) ",
"NDC11Code": "63824-0505-26",
"ProductNDC": "63824-505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Strength Mucinex Fast-max Cold And Flu And Mucinex Nightshift Severe Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20200619",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Reckitt Benckiser LLC",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220530",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms: coughnasal congestionminor aches and painssore throatheadachestuffy nosesinus congestion and pressure. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "68462-505-35",
"PackageDescription": "30 g in 1 TUBE (68462-505-35) ",
"NDC11Code": "68462-0505-35",
"ProductNDC": "68462-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091282",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1%is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1) , 2 Avoid use on the face, groin, or axillae. (1.2) , 3 Avoid use in perioral dermatitis or rosacea.",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide USP, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide USP has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is a white powder. It is sparingly soluble in acetone and inchloroform; slightly soluble in alcohol, methanol, dioxane, acetonitrile and ethyl acetate; very slightly soluble inether; and practically insoluble in water. Each gram of fluocinonide cream USP, 0.1%contains 1 mg micronized fluocinonide USP in a cream base of propylene glycol, diethylene glycol monoethyl ether, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate, purified water, carbomer, diisopropanolamine and anhydrous citric acid."
},
{
"NDCCode": "68462-505-65",
"PackageDescription": "60 g in 1 TUBE (68462-505-65) ",
"NDC11Code": "68462-0505-65",
"ProductNDC": "68462-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091282",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1%is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1) , 2 Avoid use on the face, groin, or axillae. (1.2) , 3 Avoid use in perioral dermatitis or rosacea.",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide USP, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide USP has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is a white powder. It is sparingly soluble in acetone and inchloroform; slightly soluble in alcohol, methanol, dioxane, acetonitrile and ethyl acetate; very slightly soluble inether; and practically insoluble in water. Each gram of fluocinonide cream USP, 0.1%contains 1 mg micronized fluocinonide USP in a cream base of propylene glycol, diethylene glycol monoethyl ether, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate, purified water, carbomer, diisopropanolamine and anhydrous citric acid."
},
{
"NDCCode": "68462-310-66",
"PackageDescription": "1 TUBE in 1 CARTON (68462-310-66) / 120 g in 1 TUBE",
"NDC11Code": "68462-0310-66",
"ProductNDC": "68462-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090633",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100324",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene ointment USP, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.",
"Description": "Calcipotriene Ointment USP, 0.005% contains the compound calcipotriene, USP a synthetic vitamin D3 derivative for topical dermatological use. Chemically, Calcipotriene, USP is 24-cyclopropyl-(1α,3β,5Z,7E,22E,24S)-9,10-Secochola-5,7,10(19),22-tetraene-1,3,24-trioI; with the empirical formula C27H40O3, a molecular weight of 412.62, and the following structural formula. Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Ointment USP, 0.005% contains calcipotriene, USP 50 mcg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, white petrolatum, propylene glycol, dl-alpha-tocopherol, steareth-2 and purified water."
},
{
"NDCCode": "68462-501-66",
"PackageDescription": "1 TUBE in 1 CARTON (68462-501-66) / 120 g in 1 TUBE",
"NDC11Code": "68462-0501-66",
"ProductNDC": "68462-501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205772",
"LabelerName": "Glenmark Pharmaceuticals Inc.,USA",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150610",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.",
"Description": "Calcipotriene Cream USP, 0.005% contains calcipotriene, USP, a synthetic vitamin D3 derivative, for topical dermatological use. Chemically, calcipotriene, USP is 24-cyclopropyl-(1α,3β,5Z,7E,22E,24S)-9,10-Secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C27H40O3, a molecular weight of 412.62 and the following structural formula. Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Cream USP, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum."
},
{
"NDCCode": "68462-831-66",
"PackageDescription": "120 g in 1 CARTON (68462-831-66) ",
"NDC11Code": "68462-0831-66",
"ProductNDC": "68462-831",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kalosar",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090633",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Vitamin D [CS],Vitamin D Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190531",
"SamplePackage": "N"
},
{
"NDCCode": "67877-505-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (67877-505-01) ",
"NDC11Code": "67877-0505-01",
"ProductNDC": "67877-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210570",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190518",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for. Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis. : 1 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 2 Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder, that is soluble in methanol, 95% ethanol and slightly soluble in water. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: Lactose monohydrate, microcrystalline cellulose (GR 101 and GR 102), crospovidone, hydroxypropyl cellulose, magnesium stearate. In addition polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, FD&C blue #2/Indigo carmine AL are included in the film coating."
},
{
"NDCCode": "67877-505-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (67877-505-30) ",
"NDC11Code": "67877-0505-30",
"ProductNDC": "67877-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210570",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190518",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for. Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis. : 1 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 2 Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder, that is soluble in methanol, 95% ethanol and slightly soluble in water. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: Lactose monohydrate, microcrystalline cellulose (GR 101 and GR 102), crospovidone, hydroxypropyl cellulose, magnesium stearate. In addition polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, FD&C blue #2/Indigo carmine AL are included in the film coating."
},
{
"NDCCode": "67877-505-33",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (67877-505-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "67877-0505-33",
"ProductNDC": "67877-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210570",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190518",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for. Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis. : 1 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 2 Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder, that is soluble in methanol, 95% ethanol and slightly soluble in water. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: Lactose monohydrate, microcrystalline cellulose (GR 101 and GR 102), crospovidone, hydroxypropyl cellulose, magnesium stearate. In addition polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, FD&C blue #2/Indigo carmine AL are included in the film coating."
},
{
"NDCCode": "72485-505-10",
"PackageDescription": "10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72485-505-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (72485-505-01) ",
"NDC11Code": "72485-0505-10",
"ProductNDC": "72485-505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213318",
"LabelerName": "Armas Pharmaceuticals Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230328",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine hydrochloride Injection, is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.",
"Description": "Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride Injection, 10 mg/mL is a clear, colorless, sterile, non-pyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α-[(methylamino)methyl] benzyl alcohol hydrochloride and is chemically designated as C9H14ClNO2 with a molecular weight of 203.66 g/mol. Its structural formula is depicted below. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride Injection, 10 mg/mL is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5-5.5."
},
{
"NDCCode": "0264-7510-00",
"PackageDescription": "12 CONTAINER in 1 CASE (0264-7510-00) / 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-7510-00",
"ProductNDC": "0264-7510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19880202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019626",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880202",
"SamplePackage": "N",
"IndicationAndUsage": "These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.",
"Description": "Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container."
},
{
"NDCCode": "0264-7510-10",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-7510-10) / 500 mL in 1 CONTAINER",
"NDC11Code": "00264-7510-10",
"ProductNDC": "0264-7510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19880202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019626",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880202",
"SamplePackage": "N",
"IndicationAndUsage": "These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.",
"Description": "Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container."
},
{
"NDCCode": "0264-7510-20",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-7510-20) / 250 mL in 1 CONTAINER",
"NDC11Code": "00264-7510-20",
"ProductNDC": "0264-7510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19880202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019626",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880202",
"SamplePackage": "N",
"IndicationAndUsage": "These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.",
"Description": "Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container."
},
{
"NDCCode": "0264-7520-00",
"PackageDescription": "12 CONTAINER in 1 CASE (0264-7520-00) / 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-7520-00",
"ProductNDC": "0264-7520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19880202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019626",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880202",
"SamplePackage": "N",
"IndicationAndUsage": "These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.",
"Description": "Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container."
},
{
"NDCCode": "0264-7520-10",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-7520-10) / 500 mL in 1 CONTAINER",
"NDC11Code": "00264-7520-10",
"ProductNDC": "0264-7520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19880202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019626",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880202",
"SamplePackage": "N",
"IndicationAndUsage": "These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.",
"Description": "Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container."
},
{
"NDCCode": "0264-7520-20",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-7520-20) / 250 mL in 1 CONTAINER",
"NDC11Code": "00264-7520-20",
"ProductNDC": "0264-7520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19880202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019626",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880202",
"SamplePackage": "N",
"IndicationAndUsage": "These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.",
"Description": "Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container."
},
{
"NDCCode": "0409-4160-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4160-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4160-03",
"ProductNDC": "0409-4160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19860403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019438",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYL-TYROSINE; GLYCINE",
"StrengthNumber": "462; 700; 735; 120; 209; 280; 140; 350; 695; 713; 490; 517; 210; 505; 371; 189; 350",
"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",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
},
{
"NDCCode": "0990-7922-02",
"PackageDescription": "24 POUCH in 1 CASE (0990-7922-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG",
"NDC11Code": "00990-7922-02",
"ProductNDC": "0990-7922",
"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": "0990-7922-03",
"PackageDescription": "24 POUCH in 1 CASE (0990-7922-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
"NDC11Code": "00990-7922-03",
"ProductNDC": "0990-7922",
"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": "0990-7922-09",
"PackageDescription": "12 POUCH in 1 CASE (0990-7922-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
"NDC11Code": "00990-7922-09",
"ProductNDC": "0990-7922",
"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": "20190901",
"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": "0990-7922-53",
"PackageDescription": "24 POUCH in 1 CASE (0990-7922-53) / 1 BAG in 1 POUCH / 250 mL in 1 BAG",
"NDC11Code": "00990-7922-53",
"ProductNDC": "0990-7922",
"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": "20191001",
"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": "0990-7922-55",
"PackageDescription": "18 POUCH in 1 CASE (0990-7922-55) / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
"NDC11Code": "00990-7922-55",
"ProductNDC": "0990-7922",
"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": "0990-7922-61",
"PackageDescription": "32 POUCH in 1 CASE (0990-7922-61) / 1 BAG in 1 POUCH / 150 mL in 1 BAG",
"NDC11Code": "00990-7922-61",
"ProductNDC": "0990-7922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"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",
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"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": "0990-7923-13",
"PackageDescription": "48 POUCH in 1 CASE (0990-7923-13) / 1 BAG in 1 POUCH / 50 mL in 1 BAG",
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"ProductNDC": "0990-7923",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
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"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": "0990-7923-20",
"PackageDescription": "12 POUCH in 1 CASE (0990-7923-20) / 4 BAG in 1 POUCH / 25 mL in 1 BAG",
"NDC11Code": "00990-7923-20",
"ProductNDC": "0990-7923",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
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"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
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"ProductNdcExcludeFlag": "N",
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"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": "0990-7923-23",
"PackageDescription": "48 POUCH in 1 CASE (0990-7923-23) / 1 BAG in 1 POUCH / 100 mL in 1 BAG",
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"ProductNDC": "0990-7923",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "ICU Medical, Inc.",
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"Status": "Active",
"LastUpdate": "2026-06-19",
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"ProductNdcExcludeFlag": "N",
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"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",
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"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": "0990-7923-37",
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"ProductNDC": "0990-7923",
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"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": "0990-7930-02",
"PackageDescription": "24 POUCH in 1 CASE (0990-7930-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG",
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"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."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68462-505-66</NDCCode>
<PackageDescription>120 g in 1 TUBE (68462-505-66) </PackageDescription>
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<Description>Fluocinonide cream USP, 0.1% contains fluocinonide USP, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide USP has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is a white powder. It is sparingly soluble in acetone and inchloroform; slightly soluble in alcohol, methanol, dioxane, acetonitrile and ethyl acetate; very slightly soluble inether; and practically insoluble in water. Each gram of fluocinonide cream USP, 0.1%contains 1 mg micronized fluocinonide USP in a cream base of propylene glycol, diethylene glycol monoethyl ether, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate, purified water, carbomer, diisopropanolamine and anhydrous citric acid.</Description>
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<ProprietaryName>Maximum Strength Mucinex Fast-max Cold And Flu And Mucinex Nightshift Severe Cold And Flu</ProprietaryName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms: coughnasal congestionminor aches and painssore throatheadachestuffy nosesinus congestion and pressure. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
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<SamplePackage>N</SamplePackage>
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<Description>Fluocinonide cream USP, 0.1% contains fluocinonide USP, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide USP has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is a white powder. It is sparingly soluble in acetone and inchloroform; slightly soluble in alcohol, methanol, dioxane, acetonitrile and ethyl acetate; very slightly soluble inether; and practically insoluble in water. Each gram of fluocinonide cream USP, 0.1%contains 1 mg micronized fluocinonide USP in a cream base of propylene glycol, diethylene glycol monoethyl ether, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate, purified water, carbomer, diisopropanolamine and anhydrous citric acid.</Description>
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<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide cream USP, 0.1%is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1) , 2 Avoid use on the face, groin, or axillae. (1.2) , 3 Avoid use in perioral dermatitis or rosacea.</IndicationAndUsage>
<Description>Fluocinonide cream USP, 0.1% contains fluocinonide USP, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide USP has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is a white powder. It is sparingly soluble in acetone and inchloroform; slightly soluble in alcohol, methanol, dioxane, acetonitrile and ethyl acetate; very slightly soluble inether; and practically insoluble in water. Each gram of fluocinonide cream USP, 0.1%contains 1 mg micronized fluocinonide USP in a cream base of propylene glycol, diethylene glycol monoethyl ether, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate, purified water, carbomer, diisopropanolamine and anhydrous citric acid.</Description>
</NDC>
<NDC>
<NDCCode>68462-310-66</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-310-66) / 120 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0310-66</NDC11Code>
<ProductNDC>68462-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090633</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene ointment USP, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.</IndicationAndUsage>
<Description>Calcipotriene Ointment USP, 0.005% contains the compound calcipotriene, USP a synthetic vitamin D3 derivative for topical dermatological use. Chemically, Calcipotriene, USP is 24-cyclopropyl-(1α,3β,5Z,7E,22E,24S)-9,10-Secochola-5,7,10(19),22-tetraene-1,3,24-trioI; with the empirical formula C27H40O3, a molecular weight of 412.62, and the following structural formula. Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Ointment USP, 0.005% contains calcipotriene, USP 50 mcg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, white petrolatum, propylene glycol, dl-alpha-tocopherol, steareth-2 and purified water.</Description>
</NDC>
<NDC>
<NDCCode>68462-501-66</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-501-66) / 120 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0501-66</NDC11Code>
<ProductNDC>68462-501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205772</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc.,USA</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.</IndicationAndUsage>
<Description>Calcipotriene Cream USP, 0.005% contains calcipotriene, USP, a synthetic vitamin D3 derivative, for topical dermatological use. Chemically, calcipotriene, USP is 24-cyclopropyl-(1α,3β,5Z,7E,22E,24S)-9,10-Secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C27H40O3, a molecular weight of 412.62 and the following structural formula. Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Cream USP, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-831-66</NDCCode>
<PackageDescription>120 g in 1 CARTON (68462-831-66) </PackageDescription>
<NDC11Code>68462-0831-66</NDC11Code>
<ProductNDC>68462-831</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kalosar</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090633</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67877-505-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (67877-505-01) </PackageDescription>
<NDC11Code>67877-0505-01</NDC11Code>
<ProductNDC>67877-505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210570</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for. Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis. : 1 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 2 Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder, that is soluble in methanol, 95% ethanol and slightly soluble in water. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: Lactose monohydrate, microcrystalline cellulose (GR 101 and GR 102), crospovidone, hydroxypropyl cellulose, magnesium stearate. In addition polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, FD&C blue #2/Indigo carmine AL are included in the film coating.</Description>
</NDC>
<NDC>
<NDCCode>67877-505-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (67877-505-30) </PackageDescription>
<NDC11Code>67877-0505-30</NDC11Code>
<ProductNDC>67877-505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210570</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for. Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis. : 1 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 2 Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder, that is soluble in methanol, 95% ethanol and slightly soluble in water. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: Lactose monohydrate, microcrystalline cellulose (GR 101 and GR 102), crospovidone, hydroxypropyl cellulose, magnesium stearate. In addition polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, FD&C blue #2/Indigo carmine AL are included in the film coating.</Description>
</NDC>
<NDC>
<NDCCode>67877-505-33</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (67877-505-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67877-0505-33</NDC11Code>
<ProductNDC>67877-505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210570</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for. Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis. : 1 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 2 Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder, that is soluble in methanol, 95% ethanol and slightly soluble in water. Cinacalcet tablets are formulated as light-green, oval-shaped, film-coated tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: Lactose monohydrate, microcrystalline cellulose (GR 101 and GR 102), crospovidone, hydroxypropyl cellulose, magnesium stearate. In addition polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, FD&C blue #2/Indigo carmine AL are included in the film coating.</Description>
</NDC>
<NDC>
<NDCCode>72485-505-10</NDCCode>
<PackageDescription>10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72485-505-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (72485-505-01) </PackageDescription>
<NDC11Code>72485-0505-10</NDC11Code>
<ProductNDC>72485-505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213318</ApplicationNumber>
<LabelerName>Armas Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine hydrochloride Injection, is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.</IndicationAndUsage>
<Description>Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride Injection, 10 mg/mL is a clear, colorless, sterile, non-pyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α-[(methylamino)methyl] benzyl alcohol hydrochloride and is chemically designated as C9H14ClNO2 with a molecular weight of 203.66 g/mol. Its structural formula is depicted below. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride Injection, 10 mg/mL is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5-5.5.</Description>
</NDC>
<NDC>
<NDCCode>0264-7510-00</NDCCode>
<PackageDescription>12 CONTAINER in 1 CASE (0264-7510-00) / 1000 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-7510-00</NDC11Code>
<ProductNDC>0264-7510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19880202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019626</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.</IndicationAndUsage>
<Description>Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
</NDC>
<NDC>
<NDCCode>0264-7510-10</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-7510-10) / 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-7510-10</NDC11Code>
<ProductNDC>0264-7510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19880202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019626</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.</IndicationAndUsage>
<Description>Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
</NDC>
<NDC>
<NDCCode>0264-7510-20</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-7510-20) / 250 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-7510-20</NDC11Code>
<ProductNDC>0264-7510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19880202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019626</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.</IndicationAndUsage>
<Description>Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
</NDC>
<NDC>
<NDCCode>0264-7520-00</NDCCode>
<PackageDescription>12 CONTAINER in 1 CASE (0264-7520-00) / 1000 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-7520-00</NDC11Code>
<ProductNDC>0264-7520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19880202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019626</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.</IndicationAndUsage>
<Description>Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
</NDC>
<NDC>
<NDCCode>0264-7520-10</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-7520-10) / 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-7520-10</NDC11Code>
<ProductNDC>0264-7520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19880202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019626</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.</IndicationAndUsage>
<Description>Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
</NDC>
<NDC>
<NDCCode>0264-7520-20</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-7520-20) / 250 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-7520-20</NDC11Code>
<ProductNDC>0264-7520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19880202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019626</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>DEXTROSE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.</IndicationAndUsage>
<Description>Each 100 mL of 5% Dextrose Injection USP contains:Hydrous Dextrose USP 5 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/literCalories per liter: 170. Each 100 mL of 10% Dextrose Injection USP contains:Hydrous Dextrose USP 10 g; Water for Injection USP qspH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonicCalories per liter: 340. Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
</NDC>
<NDC>
<NDCCode>0409-4160-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4160-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4160-03</NDC11Code>
<ProductNDC>0409-4160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19860403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019438</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYL-TYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>462; 700; 735; 120; 209; 280; 140; 350; 695; 713; 490; 517; 210; 505; 371; 189; 350</StrengthNumber>
<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</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>0990-7922-02</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0990-7922-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7922-02</NDC11Code>
<ProductNDC>0990-7922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7922-03</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0990-7922-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7922-03</NDC11Code>
<ProductNDC>0990-7922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7922-09</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-7922-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7922-09</NDC11Code>
<ProductNDC>0990-7922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7922-53</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0990-7922-53) / 1 BAG in 1 POUCH / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7922-53</NDC11Code>
<ProductNDC>0990-7922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7922-55</NDCCode>
<PackageDescription>18 POUCH in 1 CASE (0990-7922-55) / 1 BAG in 1 POUCH / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7922-55</NDC11Code>
<ProductNDC>0990-7922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7922-61</NDCCode>
<PackageDescription>32 POUCH in 1 CASE (0990-7922-61) / 1 BAG in 1 POUCH / 150 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7922-61</NDC11Code>
<ProductNDC>0990-7922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7923-13</NDCCode>
<PackageDescription>48 POUCH in 1 CASE (0990-7923-13) / 1 BAG in 1 POUCH / 50 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7923-13</NDC11Code>
<ProductNDC>0990-7923</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7923-20</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-7923-20) / 4 BAG in 1 POUCH / 25 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7923-20</NDC11Code>
<ProductNDC>0990-7923</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7923-23</NDCCode>
<PackageDescription>48 POUCH in 1 CASE (0990-7923-23) / 1 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7923-23</NDC11Code>
<ProductNDC>0990-7923</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7923-36</NDCCode>
<PackageDescription>20 POUCH in 1 CASE (0990-7923-36) / 4 BAG in 1 POUCH / 50 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7923-36</NDC11Code>
<ProductNDC>0990-7923</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7923-37</NDCCode>
<PackageDescription>20 POUCH in 1 CASE (0990-7923-37) / 4 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7923-37</NDC11Code>
<ProductNDC>0990-7923</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0990-7930-02</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0990-7930-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7930-02</NDC11Code>
<ProductNDC>0990-7930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018080</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
</NDCList>