{
"NDC": [
{
"NDCCode": "58177-311-04",
"PackageDescription": "100 TABLET in 1 BOTTLE (58177-311-04)",
"NDC11Code": "58177-0311-04",
"ProductNDC": "58177-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040365",
"LabelerName": "Ethex Corporation",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Dextroamphetamine sulfate tablets are indicated in: : 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional liability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. .",
"Description": "Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate tablets as the neutral sulfate. It has a chemical formula of (C9H13N)2·H2S04 and a molecular weight of 368.50. Structural Formula:. Each tablet, for oral administration, contains dextroamphetamine sulfate, USP, 5 mg or 10 mg. Inactive ingredients: D&C Yellow No. 10, FD&C Blue No. 2, FD&C Red No. 40, hydrated alumina, magnesium stearate, microcrystalline cellulose, and stearic acid. The 5 mg also contains: mannitol, povidone and starch. The 10 mg also contains: lactose monohydrate, maltodextrin, sodium starch glycolate, and sugar compressible."
},
{
"NDCCode": "58177-311-09",
"PackageDescription": "1000 TABLET in 1 BOTTLE (58177-311-09)",
"NDC11Code": "58177-0311-09",
"ProductNDC": "58177-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040365",
"LabelerName": "Ethex Corporation",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Dextroamphetamine sulfate tablets are indicated in: : 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional liability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. .",
"Description": "Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate tablets as the neutral sulfate. It has a chemical formula of (C9H13N)2·H2S04 and a molecular weight of 368.50. Structural Formula:. Each tablet, for oral administration, contains dextroamphetamine sulfate, USP, 5 mg or 10 mg. Inactive ingredients: D&C Yellow No. 10, FD&C Blue No. 2, FD&C Red No. 40, hydrated alumina, magnesium stearate, microcrystalline cellulose, and stearic acid. The 5 mg also contains: mannitol, povidone and starch. The 10 mg also contains: lactose monohydrate, maltodextrin, sodium starch glycolate, and sugar compressible."
},
{
"NDCCode": "58177-293-04",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-293-04)",
"NDC11Code": "58177-0293-04",
"ProductNDC": "58177-293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077176",
"LabelerName": "Ethex Corporation",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "23.75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once daily oral administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg of metoprolol succinate equivalent 25 mg of metoprolol tartrate, USP. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba wax, croscarmellose sodium, glyceryl behenate, hydrogenated vegetable oil, hypromellose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium stearyl fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate copolymer. The USP Drug Release Test is pending."
},
{
"NDCCode": "58177-310-04",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-310-04)",
"NDC11Code": "58177-0310-04",
"ProductNDC": "58177-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076733",
"LabelerName": "ETHEX Corporation",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).",
"Description": "Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide."
},
{
"NDCCode": "58177-312-04",
"PackageDescription": "100 TABLET in 1 BOTTLE (58177-312-04)",
"NDC11Code": "58177-0312-04",
"ProductNDC": "58177-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040367",
"LabelerName": "Ethex Corporation",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Dextroamphetamine sulfate tablets are indicated in: : 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional liability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. .",
"Description": "Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate tablets as the neutral sulfate. It has a chemical formula of (C9H13N)2·H2S04 and a molecular weight of 368.50. Structural Formula:. Each tablet, for oral administration, contains dextroamphetamine sulfate, USP, 5 mg or 10 mg. Inactive ingredients: D&C Yellow No. 10, FD&C Blue No. 2, FD&C Red No. 40, hydrated alumina, magnesium stearate, microcrystalline cellulose, and stearic acid. The 5 mg also contains: mannitol, povidone and starch. The 10 mg also contains: lactose monohydrate, maltodextrin, sodium starch glycolate, and sugar compressible."
},
{
"NDCCode": "58177-320-04",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-320-04)",
"NDC11Code": "58177-0320-04",
"ProductNDC": "58177-320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076720",
"LabelerName": "ETHEX Corporation",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).",
"Description": "Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide."
},
{
"NDCCode": "58177-330-04",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-330-04)",
"NDC11Code": "58177-0330-04",
"ProductNDC": "58177-330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076720",
"LabelerName": "ETHEX Corporation",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).",
"Description": "Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide."
},
{
"NDCCode": "58177-340-04",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-340-04)",
"NDC11Code": "58177-0340-04",
"ProductNDC": "58177-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077855",
"LabelerName": "ETHEX Corporation",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).",
"Description": "Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide."
},
{
"NDCCode": "58177-358-04",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-358-04)",
"NDC11Code": "58177-0358-04",
"ProductNDC": "58177-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076640",
"LabelerName": "Ethex Corporation",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "190",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once daily oral administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 and 190 mg of metoprolol succinate equivalent to 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba wax, croscarmellose sodium, glyceryl behenate, hydrogenated vegetable oil, hypromellose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium stearyl fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate copolymer. Does not comply with the dissolution test of the USP monograph for metoprolol succinate extended-release tablets."
},
{
"NDCCode": "58177-368-04",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-368-04)",
"NDC11Code": "58177-0368-04",
"ProductNDC": "58177-368",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076640",
"LabelerName": "Ethex Corporation",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once daily oral administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 and 190 mg of metoprolol succinate equivalent to 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba wax, croscarmellose sodium, glyceryl behenate, hydrogenated vegetable oil, hypromellose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium stearyl fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate copolymer. Does not comply with the dissolution test of the USP monograph for metoprolol succinate extended-release tablets."
},
{
"NDCCode": "58177-369-04",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-369-04)",
"NDC11Code": "58177-0369-04",
"ProductNDC": "58177-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077176",
"LabelerName": "Ethex Corporation",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "47.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once daily oral administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 47.5 mg of metoprolol succinate equivalent to 50 mg of metoprolol tartrate, USP. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba wax, croscarmellose sodium, glyceryl behenate, hydrogenated vegetable oil, hypromellose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium stearyl fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate copolymer. The USP dissolution test is pending."
},
{
"NDCCode": "58177-380-04",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-380-04)",
"NDC11Code": "58177-0380-04",
"ProductNDC": "58177-380",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077855",
"LabelerName": "ETHEX Corporation",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).",
"Description": "Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide."
},
{
"NDCCode": "58177-677-04",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58177-677-04)",
"NDC11Code": "58177-0677-04",
"ProductNDC": "58177-677",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"ProprietaryNameSuffix": "Controlled-release",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090925",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020553",
"LabelerName": "Ethex Corporation",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).",
"Description": "Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:. The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin. The 10 mg tablets also contain: hydroxypropyl cellulose. The 20 mg tablets also contain: polysorbate 80 and red iron oxide. The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide. The 80 mg tablets also contain: FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide. Oxycodone HCl controlled-release 10 mg, 20 mg, 40 mg, and 80 mg tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph."
},
{
"NDCCode": "58177-679-04",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58177-679-04)",
"NDC11Code": "58177-0679-04",
"ProductNDC": "58177-679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"ProprietaryNameSuffix": "Controlled-release",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090925",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020553",
"LabelerName": "Ethex Corporation",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).",
"Description": "Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:. The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin. The 10 mg tablets also contain: hydroxypropyl cellulose. The 20 mg tablets also contain: polysorbate 80 and red iron oxide. The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide. The 80 mg tablets also contain: FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide. Oxycodone HCl controlled-release 10 mg, 20 mg, 40 mg, and 80 mg tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph."
},
{
"NDCCode": "58177-681-04",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58177-681-04)",
"NDC11Code": "58177-0681-04",
"ProductNDC": "58177-681",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"ProprietaryNameSuffix": "Controlled-release",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090925",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020553",
"LabelerName": "Ethex Corporation",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).",
"Description": "Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:. The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin. The 10 mg tablets also contain: hydroxypropyl cellulose. The 20 mg tablets also contain: polysorbate 80 and red iron oxide. The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide. The 80 mg tablets also contain: FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide. Oxycodone HCl controlled-release 10 mg, 20 mg, 40 mg, and 80 mg tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph."
},
{
"NDCCode": "58177-683-04",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58177-683-04)",
"NDC11Code": "58177-0683-04",
"ProductNDC": "58177-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"ProprietaryNameSuffix": "Controlled-release",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090925",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020553",
"LabelerName": "Ethex Corporation",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).",
"Description": "Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:. The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin. The 10 mg tablets also contain: hydroxypropyl cellulose. The 20 mg tablets also contain: polysorbate 80 and red iron oxide. The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide. The 80 mg tablets also contain: FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide. Oxycodone HCl controlled-release 10 mg, 20 mg, 40 mg, and 80 mg tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph."
},
{
"NDCCode": "25021-311-04",
"PackageDescription": "25 VIAL in 1 CARTON (25021-311-04) > 4 mL in 1 VIAL",
"NDC11Code": "25021-0311-04",
"ProductNDC": "25021-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20210315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213902",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210315",
"SamplePackage": "N",
"IndicationAndUsage": "Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide injection, USP, 10 mg per mL is a sterile, nonpyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellow crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows:. Molecular formula: C12H11ClN2O5SMolecular weight: 330.75. Each mL contains: Furosemide, USP 10 mg; Water for Injection q.s.; Sodium Chloride for isotonicity; Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3."
},
{
"NDCCode": "34057-001-04",
"PackageDescription": "311 L in 1 CYLINDER (34057-001-04) ",
"NDC11Code": "34057-0001-04",
"ProductNDC": "34057-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19770101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "Oxarc, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19770101",
"SamplePackage": "N"
},
{
"NDCCode": "47621-311-04",
"PackageDescription": "20 kg in 1 DRUM (47621-311-04) ",
"NDC11Code": "47621-0311-04",
"ProductNDC": "47621-311",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pirfenidone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Raks Pharma Pvt. Limited",
"SubstanceName": "PIRFENIDONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-01-23",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "02-FEB-23"
},
{
"NDCCode": "51523-311-04",
"PackageDescription": "1 TUBE in 1 CARTON (51523-311-04) > 40 g in 1 TUBE",
"NDC11Code": "51523-0311-04",
"ProductNDC": "51523-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Face It Power Perfection",
"ProprietaryNameSuffix": "32800311",
"NonProprietaryName": "Octinoxate, Titanium Dioxide And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141120",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "THEFACESHOP CO., LTD.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "2; 1.16; 4",
"StrengthUnit": "g/40g; g/40g; g/40g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "51772-311-04",
"PackageDescription": "4 BOTTLE, SPRAY in 1 CARTON (51772-311-04) > 8 SPRAY in 1 BOTTLE, SPRAY",
"NDC11Code": "51772-0311-04",
"ProductNDC": "51772-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lazanda",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20111017",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022569",
"LabelerName": "Archimedes Pharma US Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Lazanda (fentanyl) nasal spray is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer. Patients must remain on around-the-clock opioids when taking Lazanda. Lazanda is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could occur in patients not taking chronic opioids. For this reason, Lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, or dental pain. [4]. Lazanda is intended to be prescribed only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.",
"Description": "Lazanda (fentanyl) nasal spray is a liquid formulation of fentanyl citrate intended for intranasal transmucosal administration. The product consists of a practically clear to clear, colorless, aqueous solution of fentanyl citrate in a glass multidose container to which is attached a metered-dose nasal spray pump with a visual and audible spray counter. Each actuation is designed to deliver a spray of 100 mcL of solution containing 100 mcg or 400 mcg fentanyl base, respectively. This enables doses of 100 mcg or 400 mcg to be administered using a single spray into one nostril (1 spray) and 200 mcg or 800 mcg to be administered using a single spray into both nostrils (2 sprays). Active ingredient: Fentanyl citrate, USP is N-(l-phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1). Fentanyl citrate is sparingly soluble in water (1:40). The molecular weight of the free base and citrate salt are 336.5 and 528.6, respectively. The pKa is 8.4. The compound has the following structural formula:. Lazanda is available in 2 strengths of nasal spray: 100 mcg fentanyl (yellow label) and 400 mcg fentanyl (violet label). The strength is expressed as the amount of fentanyl free base per spray, e.g., the 100 mcg strength provides 100 mcg of fentanyl free base per 100 mcL spray. Inactive ingredients: mannitol, pectin, phenylethyl alcohol, propylparaben, sucrose, water. Sodium hydroxide and/or hydrochloric acid are added if required for pH adjustment."
},
{
"NDCCode": "52959-311-04",
"PackageDescription": "400 TABLET in 1 CONTAINER (52959-311-04) ",
"NDC11Code": "52959-0311-04",
"ProductNDC": "52959-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018877",
"LabelerName": "H. J. Harkins Company Inc",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS). Allopurinol is indicated in. the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.",
"Description": "Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d ]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37°C is 80 mg/dL and is greater in an alkaline solution. The structural formula is represented below. C5H4N4O M.W. 136.11. Allopurinol Tablets USP, 100 mg and 300 mg contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Allopurinol Tablets USP, 300 mg also contain FD&C Yellow No. 6."
},
{
"NDCCode": "53145-311-04",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (53145-311-04) / 12 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "53145-0311-04",
"ProductNDC": "53145-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Auralyt",
"NonProprietaryName": "Carbamide Peroxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "Menper Distributors, Inc",
"SubstanceName": "CARBAMIDE PEROXIDE",
"StrengthNumber": "7.8",
"StrengthUnit": "mg/12mL",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "for occasional use as an aid to soften, loosen and remove excessive earwax."
},
{
"NDCCode": "55648-311-04",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55648-311-04)",
"NDC11Code": "55648-0311-04",
"ProductNDC": "55648-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091267",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white to off-white powder and is soluble in water and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose and magnesium stearate. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains iron oxide yellow as a coloring agent."
},
{
"NDCCode": "63545-311-04",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (63545-311-04) ",
"NDC11Code": "63545-0311-04",
"ProductNDC": "63545-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aurum Muriaticum",
"NonProprietaryName": "Aurum Muriaticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210415",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "GOLD TRICHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2021-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210415",
"SamplePackage": "N"
},
{
"NDCCode": "64679-311-04",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64679-311-04) ",
"NDC11Code": "64679-0311-04",
"ProductNDC": "64679-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091267",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110528",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white to off-white powder and is soluble in water and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose and magnesium stearate. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains iron oxide yellow as a coloring agent."
},
{
"NDCCode": "69241-001-04",
"PackageDescription": "311 L in 1 CYLINDER (69241-001-04) ",
"NDC11Code": "69241-0001-04",
"ProductNDC": "69241-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "RTA Pediatric Care Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N"
},
{
"NDCCode": "69366-311-04",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (69366-311-04) ",
"NDC11Code": "69366-0311-04",
"ProductNDC": "69366-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "Free And Clear",
"NonProprietaryName": "62% Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170731",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "The Honest Company",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170731",
"SamplePackage": "N",
"IndicationAndUsage": "Helps reduce bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "70797-311-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (70797-311-01) > 118 mL in 1 BOTTLE (70797-311-04) ",
"NDC11Code": "70797-0311-01",
"ProductNDC": "70797-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr. Talbots Tummy Ache Relief",
"NonProprietaryName": "Calendula Officinalis, Carbo Vegetabilis, Chamomilla, Foeniculum Vulgare, Lycopodium, Nux Moschata, Zingiber Officinale, Kali Muriaticum, Magnesia Phosphorica, Natrum Phosphoricum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20200710",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Talbot's Pharmaceuticals Family Products, LLC",
"SubstanceName": "ACTIVATED CHARCOAL; NUTMEG; POTASSIUM CHLORIDE; MATRICARIA CHAMOMILLA; CALENDULA OFFICINALIS FLOWERING TOP; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; LYCOPODIUM CLAVATUM SPORE; GINGER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; FENNEL SEED",
"StrengthNumber": "12; 12; 6; 12; 12; 6; 30; 12; 12; 12",
"StrengthUnit": "[hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2021-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200710",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves infant discomfort caused by: 1 gas, 2 colic, 3 nausea, 4 stomach pressure and cramps, 5 diarrhea, 6 upset stomach, 7 nervous tummy, 8 indigestion, 9 minor stomach pain, 10 excessive stomach acid."
},
{
"NDCCode": "70956-311-04",
"PackageDescription": "500 mL in 1 BOTTLE (70956-311-04) ",
"NDC11Code": "70956-0311-04",
"ProductNDC": "70956-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Pure Experience Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Absara Cosmetics S.A.P.I DE C.V.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>58177-311-04</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58177-311-04)</PackageDescription>
<NDC11Code>58177-0311-04</NDC11Code>
<ProductNDC>58177-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040365</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Dextroamphetamine sulfate tablets are indicated in: : 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional liability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. .</IndicationAndUsage>
<Description>Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate tablets as the neutral sulfate. It has a chemical formula of (C9H13N)2·H2S04 and a molecular weight of 368.50. Structural Formula:. Each tablet, for oral administration, contains dextroamphetamine sulfate, USP, 5 mg or 10 mg. Inactive ingredients: D&C Yellow No. 10, FD&C Blue No. 2, FD&C Red No. 40, hydrated alumina, magnesium stearate, microcrystalline cellulose, and stearic acid. The 5 mg also contains: mannitol, povidone and starch. The 10 mg also contains: lactose monohydrate, maltodextrin, sodium starch glycolate, and sugar compressible.</Description>
</NDC>
<NDC>
<NDCCode>58177-311-09</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (58177-311-09)</PackageDescription>
<NDC11Code>58177-0311-09</NDC11Code>
<ProductNDC>58177-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040365</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Dextroamphetamine sulfate tablets are indicated in: : 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional liability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. .</IndicationAndUsage>
<Description>Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate tablets as the neutral sulfate. It has a chemical formula of (C9H13N)2·H2S04 and a molecular weight of 368.50. Structural Formula:. Each tablet, for oral administration, contains dextroamphetamine sulfate, USP, 5 mg or 10 mg. Inactive ingredients: D&C Yellow No. 10, FD&C Blue No. 2, FD&C Red No. 40, hydrated alumina, magnesium stearate, microcrystalline cellulose, and stearic acid. The 5 mg also contains: mannitol, povidone and starch. The 10 mg also contains: lactose monohydrate, maltodextrin, sodium starch glycolate, and sugar compressible.</Description>
</NDC>
<NDC>
<NDCCode>58177-293-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-293-04)</PackageDescription>
<NDC11Code>58177-0293-04</NDC11Code>
<ProductNDC>58177-293</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077176</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>23.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once daily oral administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg of metoprolol succinate equivalent 25 mg of metoprolol tartrate, USP. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba wax, croscarmellose sodium, glyceryl behenate, hydrogenated vegetable oil, hypromellose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium stearyl fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate copolymer. The USP Drug Release Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>58177-310-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-310-04)</PackageDescription>
<NDC11Code>58177-0310-04</NDC11Code>
<ProductNDC>58177-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076733</ApplicationNumber>
<LabelerName>ETHEX Corporation</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).</IndicationAndUsage>
<Description>Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>58177-312-04</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58177-312-04)</PackageDescription>
<NDC11Code>58177-0312-04</NDC11Code>
<ProductNDC>58177-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040367</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Dextroamphetamine sulfate tablets are indicated in: : 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional liability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. .</IndicationAndUsage>
<Description>Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate tablets as the neutral sulfate. It has a chemical formula of (C9H13N)2·H2S04 and a molecular weight of 368.50. Structural Formula:. Each tablet, for oral administration, contains dextroamphetamine sulfate, USP, 5 mg or 10 mg. Inactive ingredients: D&C Yellow No. 10, FD&C Blue No. 2, FD&C Red No. 40, hydrated alumina, magnesium stearate, microcrystalline cellulose, and stearic acid. The 5 mg also contains: mannitol, povidone and starch. The 10 mg also contains: lactose monohydrate, maltodextrin, sodium starch glycolate, and sugar compressible.</Description>
</NDC>
<NDC>
<NDCCode>58177-320-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-320-04)</PackageDescription>
<NDC11Code>58177-0320-04</NDC11Code>
<ProductNDC>58177-320</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076720</ApplicationNumber>
<LabelerName>ETHEX Corporation</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).</IndicationAndUsage>
<Description>Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>58177-330-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-330-04)</PackageDescription>
<NDC11Code>58177-0330-04</NDC11Code>
<ProductNDC>58177-330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076720</ApplicationNumber>
<LabelerName>ETHEX Corporation</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).</IndicationAndUsage>
<Description>Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>58177-340-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-340-04)</PackageDescription>
<NDC11Code>58177-0340-04</NDC11Code>
<ProductNDC>58177-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077855</ApplicationNumber>
<LabelerName>ETHEX Corporation</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).</IndicationAndUsage>
<Description>Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>58177-358-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-358-04)</PackageDescription>
<NDC11Code>58177-0358-04</NDC11Code>
<ProductNDC>58177-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076640</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>190</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once daily oral administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 and 190 mg of metoprolol succinate equivalent to 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba wax, croscarmellose sodium, glyceryl behenate, hydrogenated vegetable oil, hypromellose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium stearyl fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate copolymer. Does not comply with the dissolution test of the USP monograph for metoprolol succinate extended-release tablets.</Description>
</NDC>
<NDC>
<NDCCode>58177-368-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-368-04)</PackageDescription>
<NDC11Code>58177-0368-04</NDC11Code>
<ProductNDC>58177-368</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076640</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once daily oral administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 and 190 mg of metoprolol succinate equivalent to 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba wax, croscarmellose sodium, glyceryl behenate, hydrogenated vegetable oil, hypromellose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium stearyl fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate copolymer. Does not comply with the dissolution test of the USP monograph for metoprolol succinate extended-release tablets.</Description>
</NDC>
<NDC>
<NDCCode>58177-369-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-369-04)</PackageDescription>
<NDC11Code>58177-0369-04</NDC11Code>
<ProductNDC>58177-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077176</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>47.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once daily oral administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 47.5 mg of metoprolol succinate equivalent to 50 mg of metoprolol tartrate, USP. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba wax, croscarmellose sodium, glyceryl behenate, hydrogenated vegetable oil, hypromellose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium stearyl fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate copolymer. The USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>58177-380-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-380-04)</PackageDescription>
<NDC11Code>58177-0380-04</NDC11Code>
<ProductNDC>58177-380</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077855</ApplicationNumber>
<LabelerName>ETHEX Corporation</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).</IndicationAndUsage>
<Description>Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>58177-677-04</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58177-677-04)</PackageDescription>
<NDC11Code>58177-0677-04</NDC11Code>
<ProductNDC>58177-677</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Controlled-release</ProprietaryNameSuffix>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090925</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020553</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).</IndicationAndUsage>
<Description>Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:. The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin. The 10 mg tablets also contain: hydroxypropyl cellulose. The 20 mg tablets also contain: polysorbate 80 and red iron oxide. The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide. The 80 mg tablets also contain: FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide. Oxycodone HCl controlled-release 10 mg, 20 mg, 40 mg, and 80 mg tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph.</Description>
</NDC>
<NDC>
<NDCCode>58177-679-04</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58177-679-04)</PackageDescription>
<NDC11Code>58177-0679-04</NDC11Code>
<ProductNDC>58177-679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Controlled-release</ProprietaryNameSuffix>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090925</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020553</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).</IndicationAndUsage>
<Description>Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:. The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin. The 10 mg tablets also contain: hydroxypropyl cellulose. The 20 mg tablets also contain: polysorbate 80 and red iron oxide. The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide. The 80 mg tablets also contain: FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide. Oxycodone HCl controlled-release 10 mg, 20 mg, 40 mg, and 80 mg tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph.</Description>
</NDC>
<NDC>
<NDCCode>58177-681-04</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58177-681-04)</PackageDescription>
<NDC11Code>58177-0681-04</NDC11Code>
<ProductNDC>58177-681</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Controlled-release</ProprietaryNameSuffix>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090925</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020553</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).</IndicationAndUsage>
<Description>Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:. The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin. The 10 mg tablets also contain: hydroxypropyl cellulose. The 20 mg tablets also contain: polysorbate 80 and red iron oxide. The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide. The 80 mg tablets also contain: FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide. Oxycodone HCl controlled-release 10 mg, 20 mg, 40 mg, and 80 mg tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph.</Description>
</NDC>
<NDC>
<NDCCode>58177-683-04</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58177-683-04)</PackageDescription>
<NDC11Code>58177-0683-04</NDC11Code>
<ProductNDC>58177-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Controlled-release</ProprietaryNameSuffix>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090925</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020553</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).</IndicationAndUsage>
<Description>Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:. The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin. The 10 mg tablets also contain: hydroxypropyl cellulose. The 20 mg tablets also contain: polysorbate 80 and red iron oxide. The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide. The 80 mg tablets also contain: FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide. Oxycodone HCl controlled-release 10 mg, 20 mg, 40 mg, and 80 mg tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph.</Description>
</NDC>
<NDC>
<NDCCode>25021-311-04</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (25021-311-04) > 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0311-04</NDC11Code>
<ProductNDC>25021-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20210315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213902</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide injection, USP, 10 mg per mL is a sterile, nonpyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellow crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows:. Molecular formula: C12H11ClN2O5SMolecular weight: 330.75. Each mL contains: Furosemide, USP 10 mg; Water for Injection q.s.; Sodium Chloride for isotonicity; Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.</Description>
</NDC>
<NDC>
<NDCCode>34057-001-04</NDCCode>
<PackageDescription>311 L in 1 CYLINDER (34057-001-04) </PackageDescription>
<NDC11Code>34057-0001-04</NDC11Code>
<ProductNDC>34057-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19770101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>Oxarc, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19770101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47621-311-04</NDCCode>
<PackageDescription>20 kg in 1 DRUM (47621-311-04) </PackageDescription>
<NDC11Code>47621-0311-04</NDC11Code>
<ProductNDC>47621-311</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pirfenidone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Raks Pharma Pvt. Limited</LabelerName>
<SubstanceName>PIRFENIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-23</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-FEB-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51523-311-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51523-311-04) > 40 g in 1 TUBE</PackageDescription>
<NDC11Code>51523-0311-04</NDC11Code>
<ProductNDC>51523-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Face It Power Perfection</ProprietaryName>
<ProprietaryNameSuffix>32800311</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>THEFACESHOP CO., LTD.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>2; 1.16; 4</StrengthNumber>
<StrengthUnit>g/40g; g/40g; g/40g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51772-311-04</NDCCode>
<PackageDescription>4 BOTTLE, SPRAY in 1 CARTON (51772-311-04) > 8 SPRAY in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>51772-0311-04</NDC11Code>
<ProductNDC>51772-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lazanda</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20111017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022569</ApplicationNumber>
<LabelerName>Archimedes Pharma US Inc.</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lazanda (fentanyl) nasal spray is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer. Patients must remain on around-the-clock opioids when taking Lazanda. Lazanda is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could occur in patients not taking chronic opioids. For this reason, Lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, or dental pain. [4]. Lazanda is intended to be prescribed only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.</IndicationAndUsage>
<Description>Lazanda (fentanyl) nasal spray is a liquid formulation of fentanyl citrate intended for intranasal transmucosal administration. The product consists of a practically clear to clear, colorless, aqueous solution of fentanyl citrate in a glass multidose container to which is attached a metered-dose nasal spray pump with a visual and audible spray counter. Each actuation is designed to deliver a spray of 100 mcL of solution containing 100 mcg or 400 mcg fentanyl base, respectively. This enables doses of 100 mcg or 400 mcg to be administered using a single spray into one nostril (1 spray) and 200 mcg or 800 mcg to be administered using a single spray into both nostrils (2 sprays). Active ingredient: Fentanyl citrate, USP is N-(l-phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1). Fentanyl citrate is sparingly soluble in water (1:40). The molecular weight of the free base and citrate salt are 336.5 and 528.6, respectively. The pKa is 8.4. The compound has the following structural formula:. Lazanda is available in 2 strengths of nasal spray: 100 mcg fentanyl (yellow label) and 400 mcg fentanyl (violet label). The strength is expressed as the amount of fentanyl free base per spray, e.g., the 100 mcg strength provides 100 mcg of fentanyl free base per 100 mcL spray. Inactive ingredients: mannitol, pectin, phenylethyl alcohol, propylparaben, sucrose, water. Sodium hydroxide and/or hydrochloric acid are added if required for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>52959-311-04</NDCCode>
<PackageDescription>400 TABLET in 1 CONTAINER (52959-311-04) </PackageDescription>
<NDC11Code>52959-0311-04</NDC11Code>
<ProductNDC>52959-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018877</ApplicationNumber>
<LabelerName>H. J. Harkins Company Inc</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS). Allopurinol is indicated in. the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.</IndicationAndUsage>
<Description>Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d ]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37°C is 80 mg/dL and is greater in an alkaline solution. The structural formula is represented below. C5H4N4O M.W. 136.11. Allopurinol Tablets USP, 100 mg and 300 mg contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Allopurinol Tablets USP, 300 mg also contain FD&C Yellow No. 6.</Description>
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<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (53145-311-04) / 12 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>53145-0311-04</NDC11Code>
<ProductNDC>53145-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Auralyt</ProprietaryName>
<NonProprietaryName>Carbamide Peroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>Menper Distributors, Inc</LabelerName>
<SubstanceName>CARBAMIDE PEROXIDE</SubstanceName>
<StrengthNumber>7.8</StrengthNumber>
<StrengthUnit>mg/12mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for occasional use as an aid to soften, loosen and remove excessive earwax.</IndicationAndUsage>
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<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55648-311-04)</PackageDescription>
<NDC11Code>55648-0311-04</NDC11Code>
<ProductNDC>55648-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091267</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white to off-white powder and is soluble in water and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose and magnesium stearate. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains iron oxide yellow as a coloring agent.</Description>
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<NDC>
<NDCCode>63545-311-04</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (63545-311-04) </PackageDescription>
<NDC11Code>63545-0311-04</NDC11Code>
<ProductNDC>63545-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aurum Muriaticum</ProprietaryName>
<NonProprietaryName>Aurum Muriaticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>GOLD TRICHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64679-311-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64679-311-04) </PackageDescription>
<NDC11Code>64679-0311-04</NDC11Code>
<ProductNDC>64679-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091267</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white to off-white powder and is soluble in water and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose and magnesium stearate. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains iron oxide yellow as a coloring agent.</Description>
</NDC>
<NDC>
<NDCCode>69241-001-04</NDCCode>
<PackageDescription>311 L in 1 CYLINDER (69241-001-04) </PackageDescription>
<NDC11Code>69241-0001-04</NDC11Code>
<ProductNDC>69241-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>RTA Pediatric Care Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>69366-311-04</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (69366-311-04) </PackageDescription>
<NDC11Code>69366-0311-04</NDC11Code>
<ProductNDC>69366-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>Free And Clear</ProprietaryNameSuffix>
<NonProprietaryName>62% Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>The Honest Company</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps reduce bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
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<NDC>
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<PackageDescription>1 BOTTLE in 1 CARTON (70797-311-01) > 118 mL in 1 BOTTLE (70797-311-04) </PackageDescription>
<NDC11Code>70797-0311-01</NDC11Code>
<ProductNDC>70797-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr. Talbots Tummy Ache Relief</ProprietaryName>
<NonProprietaryName>Calendula Officinalis, Carbo Vegetabilis, Chamomilla, Foeniculum Vulgare, Lycopodium, Nux Moschata, Zingiber Officinale, Kali Muriaticum, Magnesia Phosphorica, Natrum Phosphoricum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200710</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Talbot's Pharmaceuticals Family Products, LLC</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; NUTMEG; POTASSIUM CHLORIDE; MATRICARIA CHAMOMILLA; CALENDULA OFFICINALIS FLOWERING TOP; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; LYCOPODIUM CLAVATUM SPORE; GINGER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; FENNEL SEED</SubstanceName>
<StrengthNumber>12; 12; 6; 12; 12; 6; 30; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves infant discomfort caused by: 1 gas, 2 colic, 3 nausea, 4 stomach pressure and cramps, 5 diarrhea, 6 upset stomach, 7 nervous tummy, 8 indigestion, 9 minor stomach pain, 10 excessive stomach acid.</IndicationAndUsage>
</NDC>
<NDC>
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<NDC11Code>70956-0311-04</NDC11Code>
<ProductNDC>70956-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Pure Experience Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Absara Cosmetics S.A.P.I DE C.V.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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