{
"NDC": [
{
"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": "42689-005-01",
"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": "42689-006-01",
"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": "42689-008-01",
"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": "10014-007-01",
"PackageDescription": "113 L in 1 CYLINDER (10014-007-01)",
"NDC11Code": "10014-0007-01",
"ProductNDC": "10014-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen Helium Mixture 40/60",
"NonProprietaryName": "Oxygen Helium Mixture 40/60",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19721006",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Aero All Gas Company",
"SubstanceName": "OXYGEN; HELIUM",
"StrengthNumber": "400; 600",
"StrengthUnit": "mL/L; mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10056-007-01",
"PackageDescription": "30 mL in 1 BOTTLE (10056-007-01) ",
"NDC11Code": "10056-0007-01",
"ProductNDC": "10056-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Essential By Artistry Anti Acne Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170329",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Access Business Group LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170329",
"SamplePackage": "N"
},
{
"NDCCode": "10095-007-01",
"PackageDescription": "57 g in 1 PACKAGE (10095-007-01)",
"NDC11Code": "10095-0007-01",
"ProductNDC": "10095-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sulfur",
"NonProprietaryName": "Sulfur",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150505",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "World Perfumes, Inc",
"SubstanceName": "SULFUR",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Sulfur 10% Ointment."
},
{
"NDCCode": "10297-007-01",
"PackageDescription": "637.13 L in 1 CYLINDER (10297-007-01) ",
"NDC11Code": "10297-0007-01",
"ProductNDC": "10297-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heliox",
"NonProprietaryName": "Heliox",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205737",
"LabelerName": "A-OX WELDING SUPPLY CO., INC.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "200",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2022-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N"
},
{
"NDCCode": "10578-007-01",
"PackageDescription": "28 g in 1 JAR (10578-007-01)",
"NDC11Code": "10578-0007-01",
"ProductNDC": "10578-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Homeopathic Acne",
"NonProprietaryName": "Potassium Hydrate, Calcium Sulphide, Poison Nut, Cuttlefish Ink",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120427",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Indiana Botanic Gardens",
"SubstanceName": "CAUSTICUM; CALCIUM SULFIDE; STRYCHNOS NUX-VOMICA SEED; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10",
"StrengthUnit": "[hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10678-007-01",
"PackageDescription": "3539 L in 1 CYLINDER (10678-007-01)",
"NDC11Code": "10678-0007-01",
"ProductNDC": "10678-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium Oxygen Mix",
"NonProprietaryName": "Helium Oxygen Mix",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19470523",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Airgas-West, Inc.",
"SubstanceName": "HELIUM; OXYGEN",
"StrengthNumber": "600; 400",
"StrengthUnit": "mL/L; mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10702-007-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (10702-007-01) ",
"NDC11Code": "10702-0007-01",
"ProductNDC": "10702-007",
"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": "10",
"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": "10812-007-01",
"PackageDescription": "1 TUBE in 1 CARTON (10812-007-01) > 50 mL in 1 TUBE",
"NDC11Code": "10812-0007-01",
"ProductNDC": "10812-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Healthy Defense Spf50",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "50; 30",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130625",
"SamplePackage": "N"
},
{
"NDCCode": "11054-007-01",
"PackageDescription": "185 L in 1 CYLINDER (11054-007-01) ",
"NDC11Code": "11054-0007-01",
"ProductNDC": "11054-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrous Oxide",
"NonProprietaryName": "Nitrous Oxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206009",
"LabelerName": "AIRGAS USA, LLC",
"SubstanceName": "NITROUS OXIDE",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971106",
"SamplePackage": "N"
},
{
"NDCCode": "11559-007-01",
"PackageDescription": "1 JAR in 1 CARTON (11559-007-01) > 50 mL in 1 JAR (11559-007-02)",
"NDC11Code": "11559-0007-01",
"ProductNDC": "11559-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daywear",
"ProprietaryNameSuffix": "Advanced Multi-protection Antioxidant Creme Spf 15 For Dry Skin",
"NonProprietaryName": "Octisalate, Avobenzone, Homosalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "OCTISALATE; AVOBENZONE; HOMOSALATE",
"StrengthNumber": "5; 3; 2",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11712-007-01",
"PackageDescription": "25 kg in 1 DRUM (11712-007-01)",
"NDC11Code": "11712-0007-01",
"ProductNDC": "11712-007",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Methazolamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19900801",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DELMAR CHEMICALS INC",
"SubstanceName": "METHAZOLAMIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2017-12-20",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "12776-007-01",
"PackageDescription": "1 kg in 1 DRUM (12776-007-01)",
"NDC11Code": "12776-0007-01",
"ProductNDC": "12776-007",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cisatracurium Besylate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120903",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "CF Pharma Ltd.",
"SubstanceName": "CISATRACURIUM BESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "13107-007-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-007-01)",
"NDC11Code": "13107-0007-01",
"ProductNDC": "13107-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets, USP in hospitalized depressed patients has not been adequately studied.",
"Description": "Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol."
},
{
"NDCCode": "13538-007-01",
"PackageDescription": "10 kg in 1 DRUM (13538-007-01)",
"NDC11Code": "13538-0007-01",
"ProductNDC": "13538-007",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bal30072",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Euticals SpA - Rozzano Manufacturing Site",
"SubstanceName": "BAL30072",
"StrengthNumber": "10",
"StrengthUnit": "kg/10kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "13668-007-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13668-007-01) ",
"NDC11Code": "13668-0007-01",
"ProductNDC": "13668-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077903",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.",
"Description": "Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow."
},
{
"NDCCode": "14141-007-01",
"PackageDescription": "1 CASE in 1 BOX (14141-007-01) > 9 g in 1 CASE",
"NDC11Code": "14141-0007-01",
"ProductNDC": "14141-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 210-f",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "75; 78.4",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N"
}
]
}
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<NDC11Code>42689-0007-01</NDC11Code>
<ProductNDC>42689-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203158</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
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<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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<NDCCode>42689-005-01</NDCCode>
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<NDC11Code>42689-0005-01</NDC11Code>
<ProductNDC>42689-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
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<RouteName>ORAL</RouteName>
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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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<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>
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<NDC>
<NDCCode>42689-006-01</NDCCode>
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<NDC11Code>42689-0006-01</NDC11Code>
<ProductNDC>42689-006</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>30</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>
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<NDC>
<NDCCode>42689-008-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-008-01) </PackageDescription>
<NDC11Code>42689-0008-01</NDC11Code>
<ProductNDC>42689-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
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<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>42689-009-01</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>
<NDCCode>42689-010-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-010-01) </PackageDescription>
<NDC11Code>42689-0010-01</NDC11Code>
<ProductNDC>42689-010</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>100</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>42689-011-01</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>
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<ProductNDC>42689-012</ProductNDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
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<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>
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<NDC11Code>42689-0013-01</NDC11Code>
<ProductNDC>42689-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078065</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<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>
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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>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>
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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>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>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
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<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>10014-007-01</NDCCode>
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<NDC11Code>10014-0007-01</NDC11Code>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19721006</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Aero All Gas Company</LabelerName>
<SubstanceName>OXYGEN; HELIUM</SubstanceName>
<StrengthNumber>400; 600</StrengthNumber>
<StrengthUnit>mL/L; mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10056-007-01</NDCCode>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Essential By Artistry Anti Acne Treatment</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Access Business Group LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10095-007-01</NDCCode>
<PackageDescription>57 g in 1 PACKAGE (10095-007-01)</PackageDescription>
<NDC11Code>10095-0007-01</NDC11Code>
<ProductNDC>10095-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Sulfur</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>World Perfumes, Inc</LabelerName>
<SubstanceName>SULFUR</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sulfur 10% Ointment.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10297-007-01</NDCCode>
<PackageDescription>637.13 L in 1 CYLINDER (10297-007-01) </PackageDescription>
<NDC11Code>10297-0007-01</NDC11Code>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205737</ApplicationNumber>
<LabelerName>A-OX WELDING SUPPLY CO., INC.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10578-007-01</NDCCode>
<PackageDescription>28 g in 1 JAR (10578-007-01)</PackageDescription>
<NDC11Code>10578-0007-01</NDC11Code>
<ProductNDC>10578-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Homeopathic Acne</ProprietaryName>
<NonProprietaryName>Potassium Hydrate, Calcium Sulphide, Poison Nut, Cuttlefish Ink</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120427</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Indiana Botanic Gardens</LabelerName>
<SubstanceName>CAUSTICUM; CALCIUM SULFIDE; STRYCHNOS NUX-VOMICA SEED; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
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<ProductNDC>10678-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium Oxygen Mix</ProprietaryName>
<NonProprietaryName>Helium Oxygen Mix</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19470523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Airgas-West, Inc.</LabelerName>
<SubstanceName>HELIUM; OXYGEN</SubstanceName>
<StrengthNumber>600; 400</StrengthNumber>
<StrengthUnit>mL/L; mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10702-007-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (10702-007-01) </PackageDescription>
<NDC11Code>10702-0007-01</NDC11Code>
<ProductNDC>10702-007</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>10</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>10812-007-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10812-007-01) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>10812-0007-01</NDC11Code>
<ProductNDC>10812-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Healthy Defense Spf50</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130625</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>50; 30</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11054-007-01</NDCCode>
<PackageDescription>185 L in 1 CYLINDER (11054-007-01) </PackageDescription>
<NDC11Code>11054-0007-01</NDC11Code>
<ProductNDC>11054-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrous Oxide</ProprietaryName>
<NonProprietaryName>Nitrous Oxide</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206009</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>NITROUS OXIDE</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11559-007-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11559-007-01) > 50 mL in 1 JAR (11559-007-02)</PackageDescription>
<NDC11Code>11559-0007-01</NDC11Code>
<ProductNDC>11559-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daywear</ProprietaryName>
<ProprietaryNameSuffix>Advanced Multi-protection Antioxidant Creme Spf 15 For Dry Skin</ProprietaryNameSuffix>
<NonProprietaryName>Octisalate, Avobenzone, Homosalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>OCTISALATE; AVOBENZONE; HOMOSALATE</SubstanceName>
<StrengthNumber>5; 3; 2</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11712-007-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (11712-007-01)</PackageDescription>
<NDC11Code>11712-0007-01</NDC11Code>
<ProductNDC>11712-007</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Methazolamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19900801</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DELMAR CHEMICALS INC</LabelerName>
<SubstanceName>METHAZOLAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12776-007-01</NDCCode>
<PackageDescription>1 kg in 1 DRUM (12776-007-01)</PackageDescription>
<NDC11Code>12776-0007-01</NDC11Code>
<ProductNDC>12776-007</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120903</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>CF Pharma Ltd.</LabelerName>
<SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13107-007-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-007-01)</PackageDescription>
<NDC11Code>13107-0007-01</NDC11Code>
<ProductNDC>13107-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets, USP in hospitalized depressed patients has not been adequately studied.</IndicationAndUsage>
<Description>Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>13538-007-01</NDCCode>
<PackageDescription>10 kg in 1 DRUM (13538-007-01)</PackageDescription>
<NDC11Code>13538-0007-01</NDC11Code>
<ProductNDC>13538-007</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bal30072</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Euticals SpA - Rozzano Manufacturing Site</LabelerName>
<SubstanceName>BAL30072</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>kg/10kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13668-007-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13668-007-01) </PackageDescription>
<NDC11Code>13668-0007-01</NDC11Code>
<ProductNDC>13668-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077903</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.</IndicationAndUsage>
<Description>Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>14141-007-01</NDCCode>
<PackageDescription>1 CASE in 1 BOX (14141-007-01) > 9 g in 1 CASE</PackageDescription>
<NDC11Code>14141-0007-01</NDC11Code>
<ProductNDC>14141-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 210-f</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>75; 78.4</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>