{
"NDC": [
{
"NDCCode": "0615-4554-67",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (0615-4554-67) ",
"NDC11Code": "00615-4554-67",
"ProductNDC": "0615-4554",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110421",
"EndMarketingDate": "20210228",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "NCS HealthCare of KY, Inc dba Vangard Labs",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110421",
"EndMarketingDatePackage": "20210228",
"SamplePackage": "N"
},
{
"NDCCode": "0615-4554-92",
"PackageDescription": "62 TABLET in 1 BLISTER PACK (0615-4554-92)",
"NDC11Code": "00615-4554-92",
"ProductNDC": "0615-4554",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100804",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "NCS HealthCare of KY, Inc dba Vangard Labs",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0615-8281-67",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (0615-8281-67) ",
"NDC11Code": "00615-8281-67",
"ProductNDC": "0615-8281",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181018",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190509",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "0615-8398-67",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (0615-8398-67) ",
"NDC11Code": "00615-8398-67",
"ProductNDC": "0615-8398",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111215",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210422",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps."
},
{
"NDCCode": "0615-8609-67",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (0615-8609-67) ",
"NDC11Code": "00615-8609-67",
"ProductNDC": "0615-8609",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250709",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260217",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce fever and for the temporary relief of minor aches andpains due to: 1 headache , 2 muscular aches, 3 backache, 4 minor pain from arthritis , 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps, 8 temporarily reduces fever."
},
{
"NDCCode": "0615-8203-05",
"PackageDescription": "15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8203-05) ",
"NDC11Code": "00615-8203-05",
"ProductNDC": "0615-8203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190410",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "0615-8203-39",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8203-39) ",
"NDC11Code": "00615-8203-39",
"ProductNDC": "0615-8203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131211",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "0615-8204-05",
"PackageDescription": "15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8204-05) ",
"NDC11Code": "00615-8204-05",
"ProductNDC": "0615-8204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190411",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "0615-8204-39",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8204-39) ",
"NDC11Code": "00615-8204-39",
"ProductNDC": "0615-8204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131211",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "0615-8290-39",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8290-39) ",
"NDC11Code": "00615-8290-39",
"ProductNDC": "0615-8290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190610",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "0023-4554-05",
"PackageDescription": "5 VIAL, SINGLE-USE in 1 CARTON (0023-4554-05) / .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00023-4554-05",
"ProductNDC": "0023-4554",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Refresh Celluvisc",
"NonProprietaryName": "Carboxymethylcellulose Sodium",
"DosageFormName": "GEL",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19891004",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19891004",
"SamplePackage": "Y",
"IndicationAndUsage": "For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation."
},
{
"NDCCode": "0023-4554-30",
"PackageDescription": "30 VIAL, SINGLE-USE in 1 CARTON (0023-4554-30) / .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00023-4554-30",
"ProductNDC": "0023-4554",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Refresh Celluvisc",
"NonProprietaryName": "Carboxymethylcellulose Sodium",
"DosageFormName": "GEL",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19891004",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19891004",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation."
},
{
"NDCCode": "0220-4554-41",
"PackageDescription": "5 [hp_C] in 1 TUBE (0220-4554-41) ",
"NDC11Code": "00220-4554-41",
"ProductNDC": "0220-4554",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sanguinarinum Nitricum",
"NonProprietaryName": "Sanguinarine Nitrate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "SANGUINARINE NITRATE",
"StrengthNumber": "5",
"StrengthUnit": "[hp_C]/5[hp_C]",
"Status": "Active",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: See symptoms on front panel. Relieves watery, burning nasal discharge during the day *."
},
{
"NDCCode": "0363-4554-08",
"PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (0363-4554-08) * 12 TABLET, FILM COATED in 1 BLISTER PACK * 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00363-4554-08",
"ProductNDC": "0363-4554",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Congestion And Pain",
"ProprietaryNameSuffix": "Daytime/nighttime",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20050726",
"EndMarketingDate": "20190808",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Walgreen Company",
"Status": "Deprecated",
"LastUpdate": "2019-08-09",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "17575-005-05",
"PackageDescription": "4554 L in 1 CYLINDER (17575-005-05) ",
"NDC11Code": "17575-0005-05",
"ProductNDC": "17575-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium",
"NonProprietaryName": "Helium",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19660101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205819",
"LabelerName": "AGL Inhalation Therapy Co.",
"SubstanceName": "HELIUM",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2026-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19660101",
"SamplePackage": "N"
},
{
"NDCCode": "17575-190-01",
"PackageDescription": "4554 L in 1 CYLINDER (17575-190-01)",
"NDC11Code": "17575-0190-01",
"ProductNDC": "17575-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen Helium Mixture 20/80",
"NonProprietaryName": "Oxygen Helium Mixture 20/80",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19660101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "AGL Inhalation Therapy Co.",
"SubstanceName": "OXYGEN; HELIUM",
"StrengthNumber": "200; 800",
"StrengthUnit": "mL/L; mL/L",
"Status": "Deprecated",
"LastUpdate": "2016-02-12"
},
{
"NDCCode": "17575-192-01",
"PackageDescription": "4554 L in 1 CYLINDER (17575-192-01) ",
"NDC11Code": "17575-0192-01",
"ProductNDC": "17575-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen Helium Mixture 20/80",
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"DosageFormName": "GAS",
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"SubstanceName": "OXYGEN",
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"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2026-02-19",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19660101",
"SamplePackage": "N"
},
{
"NDCCode": "50090-4554-0",
"PackageDescription": "10 mL in 1 VIAL, SINGLE-USE (50090-4554-0) ",
"NDC11Code": "50090-4554-00",
"ProductNDC": "50090-4554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "19790807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086283",
"LabelerName": "A-S Medication Solutions",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190925",
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"IndicationAndUsage": "Lidocaine Hydrochloride Jelly USP, 2% is indicated for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).",
"Description": "Lidocaine Hydrochloride Jelly USP, 2% is a sterile aqueous product that contains a local anesthetic agent and is administered topically. See INDICATIONS for specific uses. Lidocaine Hydrochloride Jelly USP, 2% contains lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula."
},
{
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"PackageDescription": "29.5 mL in 1 BOTTLE, SPRAY (51628-4554-1) ",
"NDC11Code": "51628-4554-01",
"ProductNDC": "51628-4554",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ashley Belle 1 Oz., Moisturizing Hand Sanitizing, Gingerbread Cake",
"NonProprietaryName": "Ethyl Alcohol 70% V/v",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260629",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "MY IMPORTS USA LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20260629",
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"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use."
},
{
"NDCCode": "55714-4554-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-4554-1)",
"NDC11Code": "55714-4554-01",
"ProductNDC": "55714-4554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viral Infection",
"NonProprietaryName": "Influenza A Virus, Influenza B Virus, Morbillinum, Aconitum Nap., Antimon. Tart., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Gaultheria Procumbens, Hepar Sulph. Calc., Iodium, Lachesis, Lycopodium, Merc.viv., Phosphorus, Pulsatilla, Rhus Toxicodendron, Trifolium Pratense, Echinacea, Hydrastis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-4554-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-4554-2)",
"NDC11Code": "55714-4554-02",
"ProductNDC": "55714-4554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viral Infection",
"NonProprietaryName": "Influenza A Virus, Influenza B Virus, Morbillinum, Aconitum Nap., Antimon. Tart., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Gaultheria Procumbens, Hepar Sulph. Calc., Iodium, Lachesis, Lycopodium, Merc.viv., Phosphorus, Pulsatilla, Rhus Toxicodendron, Trifolium Pratense, Echinacea, Hydrastis",
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"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
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},
{
"NDCCode": "70518-4554-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4554-0) ",
"NDC11Code": "70518-4554-00",
"ProductNDC": "70518-4554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trifluoperazine Hydrochloride",
"NonProprietaryName": "Trifluoperazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085786",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "TRIFLUOPERAZINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
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"LastUpdate": "2026-09-17",
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"IndicationAndUsage": "For the management of schizophrenia. Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine HCl is not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines). When used in the treatment of non-psychotic anxiety, trifluoperazine HCl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine HCl at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of trifluoperazine HCl as a treatment for non-psychotic anxiety was established in a four-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence does not predict that trifluoperazine HCl will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (i.e., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Trifluoperazine HCl has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Each tablet for oral administration contains trifluoperazine hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or 10 mg trifluoperazine. The structural formula is. 10- H-Phenothiazine, 10-[3-(4-methyl-1-piperazinyl)propyl]-2-(trifluoromethyl)-, dihydrochloride. Inactive ingredients: D & C Red #30 Aluminum Lake, FD & C Blue #2 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, polyethylene glycol, povidone, starch (corn), and titanium dioxide."
},
{
"NDCCode": "0113-0615-01",
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"NDC11Code": "00113-0615-01",
"ProductNDC": "0113-0615",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Itchy Eye",
"ProprietaryNameSuffix": "Original Prescription Strength",
"NonProprietaryName": "Ketotifen",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19971028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077958",
"LabelerName": "L Perrigo Company",
"SubstanceName": "KETOTIFEN FUMARATE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
},
{
"NDCCode": "0135-0615-01",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flonase Sensimist",
"ProprietaryNameSuffix": "Allergy Relief",
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"ApplicationNumber": "NDA022051",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "FLUTICASONE FUROATE",
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"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
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"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170201",
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"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes (for ages 12 and older)."
},
{
"NDCCode": "0135-0615-02",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (0135-0615-02) / 60 SPRAY, METERED in 1 BOTTLE",
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"ProductNDC": "0135-0615",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022051",
"LabelerName": "Haleon US Holdings LLC",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20170201",
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},
{
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},
{
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{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flonase Sensimist",
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"LabelerName": "Haleon US Holdings LLC",
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"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes (for ages 12 and older)."
},
{
"NDCCode": "0135-0615-06",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (0135-0615-06) / 72 SPRAY, METERED in 1 BOTTLE",
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"ProductNDC": "0135-0615",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flonase Sensimist",
"ProprietaryNameSuffix": "Allergy Relief",
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"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022051",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "FLUTICASONE FUROATE",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190122",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes (for ages 12 and older)."
},
{
"NDCCode": "0178-0615-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0178-0615-01) ",
"NDC11Code": "00178-0615-01",
"ProductNDC": "0178-0615",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urocit-k",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100127",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019071",
"LabelerName": "Mission Pharmacal Company",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "15",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100127",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Renal Tubular Acidosis (RTA) with Calcium Stones. Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology. Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)]. 1.3 Uric Acid Lithiasis with or without Calcium Stones. Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].",
"Description": "Urocit-K is a citrate salt of potassium. Its empirical formula is K3C6H507 H20, and it has the following chemical structure. Urocit-K yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate."
}
]
}
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<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-02</LastUpdate>
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<StartMarketingDatePackage>20110421</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
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<PackageDescription>60 TABLET in 1 BLISTER PACK (0615-8281-67) </PackageDescription>
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<SubstanceName>ACETAMINOPHEN</SubstanceName>
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<SamplePackage>N</SamplePackage>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111215</StartMarketingDate>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
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<StartMarketingDatePackage>20210422</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps.</IndicationAndUsage>
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<ProprietaryName>Acetaminophen</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250709</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce fever and for the temporary relief of minor aches andpains due to: 1 headache , 2 muscular aches, 3 backache, 4 minor pain from arthritis , 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps, 8 temporarily reduces fever.</IndicationAndUsage>
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<PackageDescription>15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8203-05) </PackageDescription>
<NDC11Code>00615-8203-05</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190410</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
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<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8203-39) </PackageDescription>
<NDC11Code>00615-8203-39</NDC11Code>
<ProductNDC>0615-8203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
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<PackageDescription>15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8204-05) </PackageDescription>
<NDC11Code>00615-8204-05</NDC11Code>
<ProductNDC>0615-8204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190411</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
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<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8204-39) </PackageDescription>
<NDC11Code>00615-8204-39</NDC11Code>
<ProductNDC>0615-8204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
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<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
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<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
</NDC>
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<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8290-39) </PackageDescription>
<NDC11Code>00615-8290-39</NDC11Code>
<ProductNDC>0615-8290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
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<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190610</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1), 2 Generalized Anxiety Disorder (GAD) (1), 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1), 4 Chronic Musculoskeletal Pain (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
</NDC>
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<NDCCode>0023-4554-05</NDCCode>
<PackageDescription>5 VIAL, SINGLE-USE in 1 CARTON (0023-4554-05) / .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00023-4554-05</NDC11Code>
<ProductNDC>0023-4554</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Refresh Celluvisc</ProprietaryName>
<NonProprietaryName>Carboxymethylcellulose Sodium</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19891004</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19891004</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0023-4554-30</NDCCode>
<PackageDescription>30 VIAL, SINGLE-USE in 1 CARTON (0023-4554-30) / .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00023-4554-30</NDC11Code>
<ProductNDC>0023-4554</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Refresh Celluvisc</ProprietaryName>
<NonProprietaryName>Carboxymethylcellulose Sodium</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19891004</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19891004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.</IndicationAndUsage>
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<LabelerName>Boiron</LabelerName>
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<StrengthNumber>5</StrengthNumber>
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<Status>Active</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: See symptoms on front panel. Relieves watery, burning nasal discharge during the day *.</IndicationAndUsage>
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<NDC>
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<PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (0363-4554-08) * 12 TABLET, FILM COATED in 1 BLISTER PACK * 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00363-4554-08</NDC11Code>
<ProductNDC>0363-4554</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Congestion And Pain</ProprietaryName>
<ProprietaryNameSuffix>Daytime/nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20050726</StartMarketingDate>
<EndMarketingDate>20190808</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-08-09</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<NDC>
<NDCCode>17575-005-05</NDCCode>
<PackageDescription>4554 L in 1 CYLINDER (17575-005-05) </PackageDescription>
<NDC11Code>17575-0005-05</NDC11Code>
<ProductNDC>17575-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium</ProprietaryName>
<NonProprietaryName>Helium</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19660101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205819</ApplicationNumber>
<LabelerName>AGL Inhalation Therapy Co.</LabelerName>
<SubstanceName>HELIUM</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19660101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>17575-190-01</NDCCode>
<PackageDescription>4554 L in 1 CYLINDER (17575-190-01)</PackageDescription>
<NDC11Code>17575-0190-01</NDC11Code>
<ProductNDC>17575-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen Helium Mixture 20/80</ProprietaryName>
<NonProprietaryName>Oxygen Helium Mixture 20/80</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19660101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>AGL Inhalation Therapy Co.</LabelerName>
<SubstanceName>OXYGEN; HELIUM</SubstanceName>
<StrengthNumber>200; 800</StrengthNumber>
<StrengthUnit>mL/L; mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-02-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>17575-192-01</NDCCode>
<PackageDescription>4554 L in 1 CYLINDER (17575-192-01) </PackageDescription>
<NDC11Code>17575-0192-01</NDC11Code>
<ProductNDC>17575-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen Helium Mixture 20/80</ProprietaryName>
<NonProprietaryName>Oxygen Helium Mixture 20/80</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19660101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>AGL Inhalation Therapy Co.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19660101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-4554-0</NDCCode>
<PackageDescription>10 mL in 1 VIAL, SINGLE-USE (50090-4554-0) </PackageDescription>
<NDC11Code>50090-4554-00</NDC11Code>
<ProductNDC>50090-4554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19790807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086283</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Jelly USP, 2% is indicated for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Jelly USP, 2% is a sterile aqueous product that contains a local anesthetic agent and is administered topically. See INDICATIONS for specific uses. Lidocaine Hydrochloride Jelly USP, 2% contains lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>51628-4554-1</NDCCode>
<PackageDescription>29.5 mL in 1 BOTTLE, SPRAY (51628-4554-1) </PackageDescription>
<NDC11Code>51628-4554-01</NDC11Code>
<ProductNDC>51628-4554</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ashley Belle 1 Oz., Moisturizing Hand Sanitizing, Gingerbread Cake</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol 70% V/v</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260629</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>MY IMPORTS USA LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-4554-1</NDCCode>
<PackageDescription>29.57 mL in 1 BOTTLE, GLASS (55714-4554-1)</PackageDescription>
<NDC11Code>55714-4554-01</NDC11Code>
<ProductNDC>55714-4554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viral Infection</ProprietaryName>
<NonProprietaryName>Influenza A Virus, Influenza B Virus, Morbillinum, Aconitum Nap., Antimon. Tart., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Gaultheria Procumbens, Hepar Sulph. Calc., Iodium, Lachesis, Lycopodium, Merc.viv., Phosphorus, Pulsatilla, Rhus Toxicodendron, Trifolium Pratense, Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; GOLDENSEAL</SubstanceName>
<StrengthNumber>30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-4554-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-4554-2)</PackageDescription>
<NDC11Code>55714-4554-02</NDC11Code>
<ProductNDC>55714-4554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viral Infection</ProprietaryName>
<NonProprietaryName>Influenza A Virus, Influenza B Virus, Morbillinum, Aconitum Nap., Antimon. Tart., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Gaultheria Procumbens, Hepar Sulph. Calc., Iodium, Lachesis, Lycopodium, Merc.viv., Phosphorus, Pulsatilla, Rhus Toxicodendron, Trifolium Pratense, Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; GOLDENSEAL</SubstanceName>
<StrengthNumber>30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70518-4554-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4554-0) </PackageDescription>
<NDC11Code>70518-4554-00</NDC11Code>
<ProductNDC>70518-4554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trifluoperazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trifluoperazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085786</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>TRIFLUOPERAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of schizophrenia. Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine HCl is not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines). When used in the treatment of non-psychotic anxiety, trifluoperazine HCl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine HCl at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of trifluoperazine HCl as a treatment for non-psychotic anxiety was established in a four-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence does not predict that trifluoperazine HCl will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (i.e., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Trifluoperazine HCl has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Each tablet for oral administration contains trifluoperazine hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or 10 mg trifluoperazine. The structural formula is. 10- H-Phenothiazine, 10-[3-(4-methyl-1-piperazinyl)propyl]-2-(trifluoromethyl)-, dihydrochloride. Inactive ingredients: D & C Red #30 Aluminum Lake, FD & C Blue #2 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, polyethylene glycol, povidone, starch (corn), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0113-0615-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0113-0615-01) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00113-0615-01</NDC11Code>
<ProductNDC>0113-0615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Itchy Eye</ProprietaryName>
<ProprietaryNameSuffix>Original Prescription Strength</ProprietaryNameSuffix>
<NonProprietaryName>Ketotifen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19971028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077958</ApplicationNumber>
<LabelerName>L Perrigo Company</LabelerName>
<SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0135-0615-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0135-0615-01) / 30 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00135-0615-01</NDC11Code>
<ProductNDC>0135-0615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flonase Sensimist</ProprietaryName>
<ProprietaryNameSuffix>Allergy Relief</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022051</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>27.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes (for ages 12 and older).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0615-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (0135-0615-02) / 60 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00135-0615-02</NDC11Code>
<ProductNDC>0135-0615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flonase Sensimist</ProprietaryName>
<ProprietaryNameSuffix>Allergy Relief</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022051</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>27.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes (for ages 12 and older).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0615-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (0135-0615-03) / 120 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00135-0615-03</NDC11Code>
<ProductNDC>0135-0615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flonase Sensimist</ProprietaryName>
<ProprietaryNameSuffix>Allergy Relief</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022051</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>27.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes (for ages 12 and older).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0615-04</NDCCode>
<PackageDescription>3 BOTTLE in 1 PACKAGE (0135-0615-04) / 120 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00135-0615-04</NDC11Code>
<ProductNDC>0135-0615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flonase Sensimist</ProprietaryName>
<ProprietaryNameSuffix>Allergy Relief</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022051</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>27.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes (for ages 12 and older).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0615-05</NDCCode>
<PackageDescription>2 BOTTLE in 1 PACKAGE (0135-0615-05) / 120 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00135-0615-05</NDC11Code>
<ProductNDC>0135-0615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flonase Sensimist</ProprietaryName>
<ProprietaryNameSuffix>Allergy Relief</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022051</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>27.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes (for ages 12 and older).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0615-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (0135-0615-06) / 72 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00135-0615-06</NDC11Code>
<ProductNDC>0135-0615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flonase Sensimist</ProprietaryName>
<ProprietaryNameSuffix>Allergy Relief</ProprietaryNameSuffix>
<NonProprietaryName>Fluticasone Furoate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022051</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE</SubstanceName>
<StrengthNumber>27.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes (for ages 12 and older).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0178-0615-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0178-0615-01) </PackageDescription>
<NDC11Code>00178-0615-01</NDC11Code>
<ProductNDC>0178-0615</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Urocit-k</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100127</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019071</ApplicationNumber>
<LabelerName>Mission Pharmacal Company</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Renal Tubular Acidosis (RTA) with Calcium Stones. Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology. Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)]. 1.3 Uric Acid Lithiasis with or without Calcium Stones. Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].</IndicationAndUsage>
<Description>Urocit-K is a citrate salt of potassium. Its empirical formula is K3C6H507 H20, and it has the following chemical structure. Urocit-K yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate.</Description>
</NDC>
</NDCList>