{
"NDC": [
{
"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": "42689-014-10",
"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": "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": "42689-007-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-007-01) ",
"NDC11Code": "42689-0007-01",
"ProductNDC": "42689-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203158",
"LabelerName": "Nortec Development Associates, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090407",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42689-008-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-008-01) ",
"NDC11Code": "42689-0008-01",
"ProductNDC": "42689-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203158",
"LabelerName": "Nortec Development Associates, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090407",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42689-009-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-009-01) ",
"NDC11Code": "42689-0009-01",
"ProductNDC": "42689-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203158",
"LabelerName": "Nortec Development Associates, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090407",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42689-010-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-010-01) ",
"NDC11Code": "42689-0010-01",
"ProductNDC": "42689-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203158",
"LabelerName": "Nortec Development Associates, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090407",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42689-011-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-011-01) ",
"NDC11Code": "42689-0011-01",
"ProductNDC": "42689-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42689-012-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-012-01) ",
"NDC11Code": "42689-0012-01",
"ProductNDC": "42689-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42689-013-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-013-01) ",
"NDC11Code": "42689-0013-01",
"ProductNDC": "42689-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078065",
"LabelerName": "Nortec Development Associates, Inc",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42689-011-10",
"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": "10348-014-01",
"PackageDescription": "1 TUBE in 1 CARTON (10348-014-01) > 30 mL in 1 TUBE",
"NDC11Code": "10348-0014-01",
"ProductNDC": "10348-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camera Ready",
"ProprietaryNameSuffix": "Cc Broad Spectrum Spf 30",
"NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SMASHBOX BEAUTY COSMETICS, INC",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": ".08175; .0436; .02725; .0119",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130201",
"SamplePackage": "N"
},
{
"NDCCode": "10702-014-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (10702-014-01) ",
"NDC11Code": "10702-0014-01",
"ProductNDC": "10702-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betaxolol Hydrochloride",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078962",
"LabelerName": "KVK-TECH, INC.",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111102",
"SamplePackage": "N",
"IndicationAndUsage": "Betaxolol tablets, USP is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.",
"Description": "Betaxolol hydrochloride is a ß 1-selective (cardioselective) adrenergic receptor blocking agent available as 10-mg and 20-mg tablets for oral administration. Betaxolol hydrochloride is chemically described as 2-propanol, 1- [4-[2-(cyclopropylmethoxy) ethyl] phenoxy]-3-[(1-methylethyl) amino]-, hydrochloride, (±)-. It has the following chemical structure:. Each tablet for oral administration contains 10 mg or 20 mg of betaxolol hydrochloride equivalent to 8.94 mg or 17.88 mg of betaxolol respectively. In addition, each tablet contains the following inactive ingredients, hypromellose, anhydrous lactose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, stearic acid and titanium dioxide. Betaxolol hydrochloride is a water-soluble white crystalline powder with a molecular formula of C 18H 29NO 3HCl and a molecular weight of 343.9. It is freely soluble in water, ethanol, chloroform, and methanol, and has a pKa of 9.4."
},
{
"NDCCode": "10736-014-01",
"PackageDescription": "988 L in 1 CYLINDER (10736-014-01) ",
"NDC11Code": "10736-0014-01",
"ProductNDC": "10736-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbon Dioxide",
"NonProprietaryName": "Carbon Dioxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19630101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206025",
"LabelerName": "MEDICAL-TECHNICAL GASES, INC.",
"SubstanceName": "CARBON DIOXIDE",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19630101",
"SamplePackage": "N"
},
{
"NDCCode": "10812-014-01",
"PackageDescription": "124 mL in 1 TUBE (10812-014-01) ",
"NDC11Code": "10812-0014-01",
"ProductNDC": "10812-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Naturals Acne Foaming Scrub",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121101",
"EndMarketingDate": "20210325",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121101",
"EndMarketingDatePackage": "20210325",
"SamplePackage": "N"
},
{
"NDCCode": "10956-014-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (10956-014-01) > 50 TABLET in 1 BOTTLE, PLASTIC (10956-014-50) ",
"NDC11Code": "10956-0014-01",
"ProductNDC": "10956-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Care One Chest Congestion Relief",
"ProprietaryNameSuffix": "Dm",
"NonProprietaryName": "Dextromethorphan Hydrobromide / Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091207",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Reese Pharmaceutical Co",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110117",
"SamplePackage": "N"
},
{
"NDCCode": "11559-014-01",
"PackageDescription": "1 JAR in 1 CARTON (11559-014-01) > 11 g in 1 JAR (11559-014-02)",
"NDC11Code": "11559-0014-01",
"ProductNDC": "11559-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Double Wear",
"ProprietaryNameSuffix": "Mineral Rich Loose Powder Makeup Spf 12",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "2.2",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "13107-014-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-014-01) ",
"NDC11Code": "13107-0014-01",
"ProductNDC": "13107-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202675",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230228",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.",
"Description": "Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is:. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate."
},
{
"NDCCode": "13733-014-01",
"PackageDescription": "50 mL in 1 CARTON (13733-014-01)",
"NDC11Code": "13733-0014-01",
"ProductNDC": "13733-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha All Around Safe Block Essence Sun",
"ProprietaryNameSuffix": "Spf45 Pa Plus Plus Plus",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ABLE C&C CO., LTD.",
"SubstanceName": "OCTINOXATE; OCTISALATE; ENSULIZOLE",
"StrengthNumber": "3.5; 2.4; 2",
"StrengthUnit": "mL/50mL; mL/50mL; mL/50mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INDICATION AND USAGE:- At the last step of basic skin care, apply an appropriate amount evenly over the face. Pat lightly until fully absorbed. - Apply evenly onto the face, neck, arms and legs where sun exposure occurs.- Reapply during long exposure."
},
{
"NDCCode": "14141-014-01",
"PackageDescription": "1 CASE in 1 BOX (14141-014-01) > 9 g in 1 CASE",
"NDC11Code": "14141-0014-01",
"ProductNDC": "14141-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 300-n",
"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",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "14445-014-01",
"PackageDescription": ".1 kg in 1 DRUM (14445-014-01) ",
"NDC11Code": "14445-0014-01",
"ProductNDC": "14445-014",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Apixaban",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160720",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "APIXABAN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-03-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20-JUL-16"
},
{
"NDCCode": "14783-014-01",
"PackageDescription": "1 g in 1 PACKET (14783-014-01)",
"NDC11Code": "14783-0014-01",
"ProductNDC": "14783-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Lederm 35plus Jour",
"ProprietaryNameSuffix": "Spf 15 Facial Treatment Against First Signs Of Aging Day - Oily Skin",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": ".03; .05; .03; .05",
"StrengthUnit": "g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14789-014-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (14789-014-01) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "14789-0014-01",
"ProductNDC": "14789-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ephedrine Sulfate",
"NonProprietaryName": "Ephedrine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150608",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nexus Pharmaceuticals Inc",
"SubstanceName": "EPHEDRINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "16262-014-01",
"PackageDescription": "85714 TABLET in 1 BAG (16262-014-01) ",
"NDC11Code": "16262-0014-01",
"ProductNDC": "16262-014",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Sodium Alendronate",
"DosageFormName": "TABLET",
"StartMarketingDate": "20151019",
"EndMarketingDate": "20271130",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aesica Pharmaceuticals GmbH, Zwickau",
"SubstanceName": "ALENDRONIC ACID",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-11-27",
"StartMarketingDatePackage": "19-OCT-15",
"EndMarketingDatePackage": "30-NOV-27"
},
{
"NDCCode": "16714-014-01",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (16714-014-01) ",
"NDC11Code": "16714-0014-01",
"ProductNDC": "16714-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065063",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200501",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.",
"Description": "Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 3 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)."
},
{
"NDCCode": "17714-014-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (17714-014-01) ",
"NDC11Code": "17714-0014-01",
"ProductNDC": "17714-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apap",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900114",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Advance Pharmaceutical Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2017-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900114",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor pain of arthritis, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps, 8 temporarily reduces fever."
},
{
"NDCCode": "22100-014-01",
"PackageDescription": "236 g in 1 BOTTLE (22100-014-01)",
"NDC11Code": "22100-0014-01",
"ProductNDC": "22100-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healing Waters Clean Cotton Scented Anti-bacterial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110407",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "NINGBO MEIDUO GENERAL PRODUCTS CO., LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses: To decrease bacteria on the skin that could cause diseases. Recommended for repeated use."
}
]
}
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<NDCList>
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<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>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<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>
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<NDC>
<NDCCode>42689-014-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-014-10) </PackageDescription>
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<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>42689-005-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-005-01) </PackageDescription>
<NDC11Code>42689-0005-01</NDC11Code>
<ProductNDC>42689-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<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>20</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>42689-006-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-006-01) </PackageDescription>
<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>
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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>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<LabelerName>Nortec Development Associates, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42689-008-01</NDCCode>
<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>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203158</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42689-009-01</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>
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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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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203158</ApplicationNumber>
<LabelerName>Nortec Development Associates, Inc.</LabelerName>
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<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>Morphine Sulfate Extended-Release Capsules (morphine sulfate) an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each Morphine Sulfate Extended-Release Capsules contain either 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: diethyl phthalate, ethyl cellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc and triethyl citrate. The capsule shells contain gelatin, titanium dioxide, and black ink, D&C yellow #10, FD&C yellow #6 (20 mg), D&C red #28, FD&C blue #1 (30 mg), FD&C blue #1 (50 mg), D&C red #28, FD&C blue #1, FD&C red #40 (60 mg), FD&C yellow #6, FD&C red #40 (80 mg), FD&C yellow #6, FD&C green #3 (100 mg). The black imprint ink contains shellac glaze – 45% (20% esterified) in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, D&C yellow #10 aluminum lake. The chemical name of morphine sulfate is 7,8-didehydro-4,5 α- epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
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<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>
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<NDC>
<NDCCode>42689-012-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-012-01) </PackageDescription>
<NDC11Code>42689-0012-01</NDC11Code>
<ProductNDC>42689-012</ProductNDC>
<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>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are. C 16H 21NO 2. HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, propranolol hydrochloride extended-release capsules 60 mg and 80 mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release capsules 120 mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42689-013-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-013-01) </PackageDescription>
<NDC11Code>42689-0013-01</NDC11Code>
<ProductNDC>42689-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<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>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>
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<NDC>
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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>
<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>
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<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>
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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>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>
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<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-013-10) </PackageDescription>
<NDC11Code>42689-0013-10</NDC11Code>
<ProductNDC>42689-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<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>
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<PackageDescription>1 TUBE in 1 CARTON (10348-014-01) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>10348-0014-01</NDC11Code>
<ProductNDC>10348-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Camera Ready</ProprietaryName>
<ProprietaryNameSuffix>Cc Broad Spectrum Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SMASHBOX BEAUTY COSMETICS, INC</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.08175; .0436; .02725; .0119</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10702-014-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (10702-014-01) </PackageDescription>
<NDC11Code>10702-0014-01</NDC11Code>
<ProductNDC>10702-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betaxolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078962</ApplicationNumber>
<LabelerName>KVK-TECH, INC.</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betaxolol tablets, USP is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.</IndicationAndUsage>
<Description>Betaxolol hydrochloride is a ß 1-selective (cardioselective) adrenergic receptor blocking agent available as 10-mg and 20-mg tablets for oral administration. Betaxolol hydrochloride is chemically described as 2-propanol, 1- [4-[2-(cyclopropylmethoxy) ethyl] phenoxy]-3-[(1-methylethyl) amino]-, hydrochloride, (±)-. It has the following chemical structure:. Each tablet for oral administration contains 10 mg or 20 mg of betaxolol hydrochloride equivalent to 8.94 mg or 17.88 mg of betaxolol respectively. In addition, each tablet contains the following inactive ingredients, hypromellose, anhydrous lactose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, stearic acid and titanium dioxide. Betaxolol hydrochloride is a water-soluble white crystalline powder with a molecular formula of C 18H 29NO 3HCl and a molecular weight of 343.9. It is freely soluble in water, ethanol, chloroform, and methanol, and has a pKa of 9.4.</Description>
</NDC>
<NDC>
<NDCCode>10736-014-01</NDCCode>
<PackageDescription>988 L in 1 CYLINDER (10736-014-01) </PackageDescription>
<NDC11Code>10736-0014-01</NDC11Code>
<ProductNDC>10736-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbon Dioxide</ProprietaryName>
<NonProprietaryName>Carbon Dioxide</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19630101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206025</ApplicationNumber>
<LabelerName>MEDICAL-TECHNICAL GASES, INC.</LabelerName>
<SubstanceName>CARBON DIOXIDE</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19630101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10812-014-01</NDCCode>
<PackageDescription>124 mL in 1 TUBE (10812-014-01) </PackageDescription>
<NDC11Code>10812-0014-01</NDC11Code>
<ProductNDC>10812-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Naturals Acne Foaming Scrub</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121101</StartMarketingDate>
<EndMarketingDate>20210325</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121101</StartMarketingDatePackage>
<EndMarketingDatePackage>20210325</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10956-014-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (10956-014-01) > 50 TABLET in 1 BOTTLE, PLASTIC (10956-014-50) </PackageDescription>
<NDC11Code>10956-0014-01</NDC11Code>
<ProductNDC>10956-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Care One Chest Congestion Relief</ProprietaryName>
<ProprietaryNameSuffix>Dm</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hydrobromide / Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091207</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Reese Pharmaceutical Co</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11559-014-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11559-014-01) > 11 g in 1 JAR (11559-014-02)</PackageDescription>
<NDC11Code>11559-0014-01</NDC11Code>
<ProductNDC>11559-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Double Wear</ProprietaryName>
<ProprietaryNameSuffix>Mineral Rich Loose Powder Makeup Spf 12</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>2.2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13107-014-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-014-01) </PackageDescription>
<NDC11Code>13107-0014-01</NDC11Code>
<ProductNDC>13107-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202675</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
<Description>Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is:. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>13733-014-01</NDCCode>
<PackageDescription>50 mL in 1 CARTON (13733-014-01)</PackageDescription>
<NDC11Code>13733-0014-01</NDC11Code>
<ProductNDC>13733-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha All Around Safe Block Essence Sun</ProprietaryName>
<ProprietaryNameSuffix>Spf45 Pa Plus Plus Plus</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ABLE C&C CO., LTD.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; ENSULIZOLE</SubstanceName>
<StrengthNumber>3.5; 2.4; 2</StrengthNumber>
<StrengthUnit>mL/50mL; mL/50mL; mL/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INDICATION AND USAGE:- At the last step of basic skin care, apply an appropriate amount evenly over the face. Pat lightly until fully absorbed. - Apply evenly onto the face, neck, arms and legs where sun exposure occurs.- Reapply during long exposure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-014-01</NDCCode>
<PackageDescription>1 CASE in 1 BOX (14141-014-01) > 9 g in 1 CASE</PackageDescription>
<NDC11Code>14141-0014-01</NDC11Code>
<ProductNDC>14141-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 300-n</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>
<NDC>
<NDCCode>14445-014-01</NDCCode>
<PackageDescription>.1 kg in 1 DRUM (14445-014-01) </PackageDescription>
<NDC11Code>14445-0014-01</NDC11Code>
<ProductNDC>14445-014</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160720</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-08</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-JUL-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14783-014-01</NDCCode>
<PackageDescription>1 g in 1 PACKET (14783-014-01)</PackageDescription>
<NDC11Code>14783-0014-01</NDC11Code>
<ProductNDC>14783-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Lederm 35plus Jour</ProprietaryName>
<ProprietaryNameSuffix>Spf 15 Facial Treatment Against First Signs Of Aging Day - Oily Skin</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>.03; .05; .03; .05</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14789-014-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (14789-014-01) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>14789-0014-01</NDC11Code>
<ProductNDC>14789-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ephedrine Sulfate</ProprietaryName>
<NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150608</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nexus Pharmaceuticals Inc</LabelerName>
<SubstanceName>EPHEDRINE SULFATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16262-014-01</NDCCode>
<PackageDescription>85714 TABLET in 1 BAG (16262-014-01) </PackageDescription>
<NDC11Code>16262-0014-01</NDC11Code>
<ProductNDC>16262-014</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Sodium Alendronate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20151019</StartMarketingDate>
<EndMarketingDate>20271130</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aesica Pharmaceuticals GmbH, Zwickau</LabelerName>
<SubstanceName>ALENDRONIC ACID</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-11-27</LastUpdate>
<StartMarketingDatePackage>19-OCT-15</StartMarketingDatePackage>
<EndMarketingDatePackage>30-NOV-27</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>16714-014-01</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (16714-014-01) </PackageDescription>
<NDC11Code>16714-0014-01</NDC11Code>
<ProductNDC>16714-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065063</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 3 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium).</Description>
</NDC>
<NDC>
<NDCCode>17714-014-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (17714-014-01) </PackageDescription>
<NDC11Code>17714-0014-01</NDC11Code>
<ProductNDC>17714-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apap</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Advance Pharmaceutical Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2017-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor pain of arthritis, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps, 8 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>22100-014-01</NDCCode>
<PackageDescription>236 g in 1 BOTTLE (22100-014-01)</PackageDescription>
<NDC11Code>22100-0014-01</NDC11Code>
<ProductNDC>22100-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Healing Waters Clean Cotton Scented Anti-bacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110407</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>NINGBO MEIDUO GENERAL PRODUCTS CO., LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: To decrease bacteria on the skin that could cause diseases. Recommended for repeated use.</IndicationAndUsage>
</NDC>
</NDCList>