{
"NDC": [
{
"NDCCode": "42689-006-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-006-01) ",
"NDC11Code": "42689-0006-01",
"ProductNDC": "42689-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203158",
"LabelerName": "Nortec Development Associates, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090407",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42689-005-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-005-01) ",
"NDC11Code": "42689-0005-01",
"ProductNDC": "42689-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203158",
"LabelerName": "Nortec Development Associates, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090407",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42689-007-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-007-01) ",
"NDC11Code": "42689-0007-01",
"ProductNDC": "42689-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203158",
"LabelerName": "Nortec Development Associates, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090407",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42689-008-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-008-01) ",
"NDC11Code": "42689-0008-01",
"ProductNDC": "42689-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203158",
"LabelerName": "Nortec Development Associates, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090407",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42689-009-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-009-01) ",
"NDC11Code": "42689-0009-01",
"ProductNDC": "42689-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203158",
"LabelerName": "Nortec Development Associates, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090407",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42689-010-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-010-01) ",
"NDC11Code": "42689-0010-01",
"ProductNDC": "42689-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203158",
"LabelerName": "Nortec Development Associates, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090407",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42689-011-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-011-01) ",
"NDC11Code": "42689-0011-01",
"ProductNDC": "42689-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42689-012-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-012-01) ",
"NDC11Code": "42689-0012-01",
"ProductNDC": "42689-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42689-013-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-013-01) ",
"NDC11Code": "42689-0013-01",
"ProductNDC": "42689-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42689-014-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-014-01) ",
"NDC11Code": "42689-0014-01",
"ProductNDC": "42689-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42689-011-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-011-10) ",
"NDC11Code": "42689-0011-10",
"ProductNDC": "42689-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42689-012-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-012-10) ",
"NDC11Code": "42689-0012-10",
"ProductNDC": "42689-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42689-013-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-013-10) ",
"NDC11Code": "42689-0013-10",
"ProductNDC": "42689-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42689-014-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-014-10) ",
"NDC11Code": "42689-0014-10",
"ProductNDC": "42689-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "10014-006-01",
"PackageDescription": "113 L in 1 CYLINDER (10014-006-01)",
"NDC11Code": "10014-0006-01",
"ProductNDC": "10014-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen Helium Mixture",
"NonProprietaryName": "Oxygen Helium Mixture",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19721006",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Aero All Gas Company",
"SubstanceName": "OXYGEN; HELIUM",
"StrengthNumber": "200; 800",
"StrengthUnit": "mL/L; mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10056-006-01",
"PackageDescription": "280 mL in 1 BOTTLE (10056-006-01) ",
"NDC11Code": "10056-0006-01",
"ProductNDC": "10056-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Satinique Anti Dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170329",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Access Business Group LLC",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "9.5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170329",
"SamplePackage": "N",
"IndicationAndUsage": "Controls symptoms of dandruff."
},
{
"NDCCode": "10095-006-01",
"PackageDescription": "15 g in 1 PACKAGE (10095-006-01)",
"NDC11Code": "10095-0006-01",
"ProductNDC": "10095-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quitacallos",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150505",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358F",
"LabelerName": "World Perfumes, Inc",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "17",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "QuitaCallos. Removedor de Callos. Corn & Callus Remover. Salicylic Acid 17%."
},
{
"NDCCode": "10297-006-01",
"PackageDescription": "85 L in 1 CYLINDER (10297-006-01) ",
"NDC11Code": "10297-0006-01",
"ProductNDC": "10297-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium",
"NonProprietaryName": "Helium",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211781",
"LabelerName": "A-OX Welding Supply, LLC",
"SubstanceName": "HELIUM",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N"
},
{
"NDCCode": "10348-006-01",
"PackageDescription": "1 TUBE in 1 CARTON (10348-006-01) > 50 mL in 1 TUBE",
"NDC11Code": "10348-0006-01",
"ProductNDC": "10348-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smashbox",
"ProprietaryNameSuffix": "Photo Finish Foundation Primer Spf 20",
"NonProprietaryName": "Avobenzone, Homosalate, And Octisalate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120527",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SMASHBOX BEAUTY COSMETICS, INC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE",
"StrengthNumber": "2; 15; 5",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "10526-006-01",
"PackageDescription": "230 L in 1 DEWAR (10526-006-01) ",
"NDC11Code": "10526-0006-01",
"ProductNDC": "10526-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "LIQUID",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19900101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205766",
"LabelerName": "Haun Welding Supply, Inc.",
"SubstanceName": "NITROGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900101",
"SamplePackage": "N"
},
{
"NDCCode": "10578-006-01",
"PackageDescription": "28 g in 1 JAR (10578-006-01)",
"NDC11Code": "10578-0006-01",
"ProductNDC": "10578-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Homeopathic Scar",
"NonProprietaryName": "Pot Marigold, Bushmaster Snake, Black Lead, Oil Of Mustard Seed",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120427",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Indiana Botanic Gardens",
"SubstanceName": "CALENDULA OFFICINALIS FLOWER; LACHESIS MUTA VENOM; GRAPHITE; ALLYLTHIOUREA",
"StrengthNumber": "10; 16; 10; 10",
"StrengthUnit": "[hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "10678-006-01",
"PackageDescription": "566 L in 1 CYLINDER (10678-006-01)",
"NDC11Code": "10678-0006-01",
"ProductNDC": "10678-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrous Oxide",
"NonProprietaryName": "Nitrous Oxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19470523",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Airgas-West, Inc.",
"SubstanceName": "NITROUS OXIDE",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10702-006-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (10702-006-01) ",
"NDC11Code": "10702-0006-01",
"ProductNDC": "10702-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078048",
"LabelerName": "KVK-TECH, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140731",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 5 mg Cyclobenzaprine hydrochloride. Each 10 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 10 mg Cyclobenzaprine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, carnauba wax, titanium dioxide, polyethylene glycol, and iron oxide yellow. In addition, 5 mg tablets also contain polyvinyl alcohol, talc, lecithin, and FD&C yellow # 6 / sunset yellow FCF aluminum lake. In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake and hypromellose."
},
{
"NDCCode": "10812-006-01",
"PackageDescription": "1 TUBE in 1 CARTON (10812-006-01) > 50 mL in 1 TUBE",
"NDC11Code": "10812-0006-01",
"ProductNDC": "10812-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Healthy Defense Spf30",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091201",
"EndMarketingDate": "20150102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Neutrogena Corporation",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "50; 30",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-01-09"
},
{
"NDCCode": "11054-006-01",
"PackageDescription": "85 L in 1 CYLINDER (11054-006-01) ",
"NDC11Code": "11054-0006-01",
"ProductNDC": "11054-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen, Refrigerated",
"NonProprietaryName": "Nitrogen, Refrigerated",
"DosageFormName": "LIQUID",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "19971106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205839",
"LabelerName": "Airgas Usa, LLC",
"SubstanceName": "NITROGEN",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19971106",
"SamplePackage": "N"
},
{
"NDCCode": "11084-006-01",
"PackageDescription": "47 mL in 1 BOTTLE, PLASTIC (11084-006-01) ",
"NDC11Code": "11084-0006-01",
"ProductNDC": "11084-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcare Extra Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170301",
"SamplePackage": "N",
"IndicationAndUsage": "for hand sanitizing to reduce bacteria on the skin."
},
{
"NDCCode": "11324-006-01",
"PackageDescription": "8778 L in 1 CYLINDER (11324-006-01) ",
"NDC11Code": "11324-0006-01",
"ProductNDC": "11324-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Air",
"NonProprietaryName": "Air",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20051001",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Linde Puerto Rico B.V.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "210",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051001",
"SamplePackage": "N"
},
{
"NDCCode": "11559-006-01",
"PackageDescription": "1 TUBE in 1 CARTON (11559-006-01) > 30 mL in 1 TUBE (11559-006-02)",
"NDC11Code": "11559-0006-01",
"ProductNDC": "11559-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cyber White",
"ProprietaryNameSuffix": "Brilliant Cells Full Spectrum Brightening Uv Protector Spf 50",
"NonProprietaryName": "Homosalate, Octisalate, Avobenzone, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE",
"StrengthNumber": "5; 5; 3; 3",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11673-006-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (11673-006-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "11673-0006-01",
"ProductNDC": "11673-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Fast Mucus Relief Severe Cold",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150316",
"EndMarketingDate": "20211216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Target Corporation",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150316",
"EndMarketingDatePackage": "20211216",
"SamplePackage": "N"
},
{
"NDCCode": "11994-006-02",
"PackageDescription": "2 KIT in 1 PACKAGE, COMBINATION (11994-006-02) > 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01) ",
"NDC11Code": "11994-0006-02",
"ProductNDC": "11994-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurolite",
"NonProprietaryName": "Bicisate Dihydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "19941123",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020256",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"Status": "Active",
"LastUpdate": "2022-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19941123",
"SamplePackage": "N",
"IndicationAndUsage": "Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.",
"Description": "This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic. The contents of vial A are lyophilized and stored under nitrogen. The pH of the solution before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C. Protect from light. The contents of vial B are stored under air. The pH of the solution is 7.6 ± 0.4. This vial is stored at 15-25°C. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The precise structure of the Technetium complex is [N, N'-ethylenedi-L-cysteinato(3-)]oxo[99mTc] technetium (V), diethyl ester."
}
]
}
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<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-006-01) </PackageDescription>
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<ProductNDC>42689-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Nortec Development Associates, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
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<NDCCode>42689-005-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-005-01) </PackageDescription>
<NDC11Code>42689-0005-01</NDC11Code>
<ProductNDC>42689-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
<NDCCode>42689-007-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-007-01) </PackageDescription>
<NDC11Code>42689-0007-01</NDC11Code>
<ProductNDC>42689-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203158</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42689-008-01</NDCCode>
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<NDC11Code>42689-0008-01</NDC11Code>
<ProductNDC>42689-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20090407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203158</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42689-009-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-009-01) </PackageDescription>
<NDC11Code>42689-0009-01</NDC11Code>
<ProductNDC>42689-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203158</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
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<LabelerName>Nortec Development Associates, Inc.</LabelerName>
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<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42689-011-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-011-01) </PackageDescription>
<NDC11Code>42689-0011-01</NDC11Code>
<ProductNDC>42689-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078065</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42689-012-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-012-01) </PackageDescription>
<NDC11Code>42689-0012-01</NDC11Code>
<ProductNDC>42689-012</ProductNDC>
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<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078065</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42689-013-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-013-01) </PackageDescription>
<NDC11Code>42689-0013-01</NDC11Code>
<ProductNDC>42689-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078065</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42689-014-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-014-01) </PackageDescription>
<NDC11Code>42689-0014-01</NDC11Code>
<ProductNDC>42689-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078065</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42689-011-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-011-10) </PackageDescription>
<NDC11Code>42689-0011-10</NDC11Code>
<ProductNDC>42689-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078065</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42689-012-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-012-10) </PackageDescription>
<NDC11Code>42689-0012-10</NDC11Code>
<ProductNDC>42689-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078065</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42689-013-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-013-10) </PackageDescription>
<NDC11Code>42689-0013-10</NDC11Code>
<ProductNDC>42689-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078065</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42689-014-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-014-10) </PackageDescription>
<NDC11Code>42689-0014-10</NDC11Code>
<ProductNDC>42689-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078065</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>10014-006-01</NDCCode>
<PackageDescription>113 L in 1 CYLINDER (10014-006-01)</PackageDescription>
<NDC11Code>10014-0006-01</NDC11Code>
<ProductNDC>10014-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen Helium Mixture</ProprietaryName>
<NonProprietaryName>Oxygen Helium Mixture</NonProprietaryName>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
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<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Aero All Gas Company</LabelerName>
<SubstanceName>OXYGEN; HELIUM</SubstanceName>
<StrengthNumber>200; 800</StrengthNumber>
<StrengthUnit>mL/L; mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10056-006-01</NDCCode>
<PackageDescription>280 mL in 1 BOTTLE (10056-006-01) </PackageDescription>
<NDC11Code>10056-0006-01</NDC11Code>
<ProductNDC>10056-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Satinique Anti Dandruff</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Access Business Group LLC</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>9.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Controls symptoms of dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10095-006-01</NDCCode>
<PackageDescription>15 g in 1 PACKAGE (10095-006-01)</PackageDescription>
<NDC11Code>10095-0006-01</NDC11Code>
<ProductNDC>10095-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quitacallos</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358F</ApplicationNumber>
<LabelerName>World Perfumes, Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>QuitaCallos. Removedor de Callos. Corn & Callus Remover. Salicylic Acid 17%.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10297-006-01</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211781</ApplicationNumber>
<LabelerName>A-OX Welding Supply, LLC</LabelerName>
<SubstanceName>HELIUM</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10348-006-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10348-006-01) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>10348-0006-01</NDC11Code>
<ProductNDC>10348-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smashbox</ProprietaryName>
<ProprietaryNameSuffix>Photo Finish Foundation Primer Spf 20</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, And Octisalate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SMASHBOX BEAUTY COSMETICS, INC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
<StrengthNumber>2; 15; 5</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10526-006-01</NDCCode>
<PackageDescription>230 L in 1 DEWAR (10526-006-01) </PackageDescription>
<NDC11Code>10526-0006-01</NDC11Code>
<ProductNDC>10526-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19900101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205766</ApplicationNumber>
<LabelerName>Haun Welding Supply, Inc.</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10578-006-01</NDCCode>
<PackageDescription>28 g in 1 JAR (10578-006-01)</PackageDescription>
<NDC11Code>10578-0006-01</NDC11Code>
<ProductNDC>10578-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Homeopathic Scar</ProprietaryName>
<NonProprietaryName>Pot Marigold, Bushmaster Snake, Black Lead, Oil Of Mustard Seed</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120427</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Indiana Botanic Gardens</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWER; LACHESIS MUTA VENOM; GRAPHITE; ALLYLTHIOUREA</SubstanceName>
<StrengthNumber>10; 16; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10678-006-01</NDCCode>
<PackageDescription>566 L in 1 CYLINDER (10678-006-01)</PackageDescription>
<NDC11Code>10678-0006-01</NDC11Code>
<ProductNDC>10678-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrous Oxide</ProprietaryName>
<NonProprietaryName>Nitrous Oxide</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19470523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Airgas-West, Inc.</LabelerName>
<SubstanceName>NITROUS OXIDE</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10702-006-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (10702-006-01) </PackageDescription>
<NDC11Code>10702-0006-01</NDC11Code>
<ProductNDC>10702-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078048</ApplicationNumber>
<LabelerName>KVK-TECH, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 5 mg Cyclobenzaprine hydrochloride. Each 10 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 10 mg Cyclobenzaprine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, carnauba wax, titanium dioxide, polyethylene glycol, and iron oxide yellow. In addition, 5 mg tablets also contain polyvinyl alcohol, talc, lecithin, and FD&C yellow # 6 / sunset yellow FCF aluminum lake. In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>10812-006-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10812-006-01) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>10812-0006-01</NDC11Code>
<ProductNDC>10812-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Healthy Defense Spf30</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<EndMarketingDate>20150102</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>50; 30</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>11054-006-01</NDCCode>
<PackageDescription>85 L in 1 CYLINDER (11054-006-01) </PackageDescription>
<NDC11Code>11054-0006-01</NDC11Code>
<ProductNDC>11054-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen, Refrigerated</ProprietaryName>
<NonProprietaryName>Nitrogen, Refrigerated</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>19971106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205839</ApplicationNumber>
<LabelerName>Airgas Usa, LLC</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11084-006-01</NDCCode>
<PackageDescription>47 mL in 1 BOTTLE, PLASTIC (11084-006-01) </PackageDescription>
<NDC11Code>11084-0006-01</NDC11Code>
<ProductNDC>11084-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcare Extra Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hand sanitizing to reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11324-006-01</NDCCode>
<PackageDescription>8778 L in 1 CYLINDER (11324-006-01) </PackageDescription>
<NDC11Code>11324-0006-01</NDC11Code>
<ProductNDC>11324-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Air</ProprietaryName>
<NonProprietaryName>Air</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20051001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Linde Puerto Rico B.V.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>210</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11559-006-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11559-006-01) > 30 mL in 1 TUBE (11559-006-02)</PackageDescription>
<NDC11Code>11559-0006-01</NDC11Code>
<ProductNDC>11559-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cyber White</ProprietaryName>
<ProprietaryNameSuffix>Brilliant Cells Full Spectrum Brightening Uv Protector Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Homosalate, Octisalate, Avobenzone, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE</SubstanceName>
<StrengthNumber>5; 5; 3; 3</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11673-006-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (11673-006-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0006-01</NDC11Code>
<ProductNDC>11673-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Fast Mucus Relief Severe Cold</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150316</StartMarketingDate>
<EndMarketingDate>20211216</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150316</StartMarketingDatePackage>
<EndMarketingDatePackage>20211216</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11994-006-02</NDCCode>
<PackageDescription>2 KIT in 1 PACKAGE, COMBINATION (11994-006-02) > 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01) </PackageDescription>
<NDC11Code>11994-0006-02</NDC11Code>
<ProductNDC>11994-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurolite</ProprietaryName>
<NonProprietaryName>Bicisate Dihydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19941123</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020256</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.</IndicationAndUsage>
<Description>This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic. The contents of vial A are lyophilized and stored under nitrogen. The pH of the solution before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C. Protect from light. The contents of vial B are stored under air. The pH of the solution is 7.6 ± 0.4. This vial is stored at 15-25°C. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The precise structure of the Technetium complex is [N, N'-ethylenedi-L-cysteinato(3-)]oxo[99mTc] technetium (V), diethyl ester.</Description>
</NDC>
</NDCList>