{
"NDC": [
{
"NDCCode": "48951-1361-7",
"PackageDescription": "75 g in 1 BOTTLE, GLASS (48951-1361-7) ",
"NDC11Code": "48951-1361-07",
"ProductNDC": "48951-1361",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amethyst Rosa",
"NonProprietaryName": "Amethyst Rosa",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy, Inc.",
"SubstanceName": "ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; FUMARIA OFFICINALIS FLOWERING TOP; GRAPHITE; SILICON DIOXIDE",
"StrengthNumber": "2; 5; 3; 15; 2",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "71335-1361-7",
"PackageDescription": "50 TABLET in 1 BOTTLE (71335-1361-7) ",
"NDC11Code": "71335-1361-07",
"ProductNDC": "71335-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240812",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "67296-1361-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (67296-1361-3) ",
"NDC11Code": "67296-1361-03",
"ProductNDC": "67296-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081297",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "BENZONATATE is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. [Structure for Benzonatate]. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water."
},
{
"NDCCode": "70771-1361-0",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70771-1361-0) ",
"NDC11Code": "70771-1361-00",
"ProductNDC": "70771-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208360",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "37.5; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180904",
"SamplePackage": "N",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). .",
"Description": "Triamterene and hydrochlorothiazide combines triamterene a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg contains. Triamterene, USP ..............................................................................37.5 mg. Hydrochlorothiazide, USP ................................................................25 mg. Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg contains. Triamterene, USP .............................................................................75 mg. Hydrochlorothiazide, USP ................................................................50 mg. Each triamterene and hydrochlorothiazide tablet, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP and 75 mg triamterene USP with 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and microcrystalline cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue No. 1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is soluble in formic acid. It is sparingly soluble in methoxyethanol. It is very slightly soluble in acetic acid, alcohol and dilute mineral acids. It is practically insoluble in water, benzene, ether, chloroform and dilute alkali hydroxides. Its molecular weight is 253.26. Its structural formula is. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is very slightly soluble in water. It is freely soluble in sodium hydroxide solution, n-butylamine and dimethyl formamide. It is sparingly soluble in methanol. It is insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.7. Its structural formula is:."
},
{
"NDCCode": "70771-1361-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (70771-1361-1) ",
"NDC11Code": "70771-1361-01",
"ProductNDC": "70771-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208360",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "37.5; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180904",
"SamplePackage": "N",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). .",
"Description": "Triamterene and hydrochlorothiazide combines triamterene a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg contains. Triamterene, USP ..............................................................................37.5 mg. Hydrochlorothiazide, USP ................................................................25 mg. Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg contains. Triamterene, USP .............................................................................75 mg. Hydrochlorothiazide, USP ................................................................50 mg. Each triamterene and hydrochlorothiazide tablet, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP and 75 mg triamterene USP with 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and microcrystalline cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue No. 1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is soluble in formic acid. It is sparingly soluble in methoxyethanol. It is very slightly soluble in acetic acid, alcohol and dilute mineral acids. It is practically insoluble in water, benzene, ether, chloroform and dilute alkali hydroxides. Its molecular weight is 253.26. Its structural formula is. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is very slightly soluble in water. It is freely soluble in sodium hydroxide solution, n-butylamine and dimethyl formamide. It is sparingly soluble in methanol. It is insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.7. Its structural formula is:."
},
{
"NDCCode": "70771-1361-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70771-1361-4) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "70771-1361-04",
"ProductNDC": "70771-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208360",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "37.5; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180904",
"SamplePackage": "N",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). .",
"Description": "Triamterene and hydrochlorothiazide combines triamterene a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg contains. Triamterene, USP ..............................................................................37.5 mg. Hydrochlorothiazide, USP ................................................................25 mg. Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg contains. Triamterene, USP .............................................................................75 mg. Hydrochlorothiazide, USP ................................................................50 mg. Each triamterene and hydrochlorothiazide tablet, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP and 75 mg triamterene USP with 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and microcrystalline cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue No. 1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is soluble in formic acid. It is sparingly soluble in methoxyethanol. It is very slightly soluble in acetic acid, alcohol and dilute mineral acids. It is practically insoluble in water, benzene, ether, chloroform and dilute alkali hydroxides. Its molecular weight is 253.26. Its structural formula is. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is very slightly soluble in water. It is freely soluble in sodium hydroxide solution, n-butylamine and dimethyl formamide. It is sparingly soluble in methanol. It is insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.7. Its structural formula is:."
},
{
"NDCCode": "70771-1361-5",
"PackageDescription": "500 TABLET in 1 BOTTLE (70771-1361-5) ",
"NDC11Code": "70771-1361-05",
"ProductNDC": "70771-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208360",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "37.5; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180904",
"SamplePackage": "N",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). .",
"Description": "Triamterene and hydrochlorothiazide combines triamterene a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg contains. Triamterene, USP ..............................................................................37.5 mg. Hydrochlorothiazide, USP ................................................................25 mg. Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg contains. Triamterene, USP .............................................................................75 mg. Hydrochlorothiazide, USP ................................................................50 mg. Each triamterene and hydrochlorothiazide tablet, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP and 75 mg triamterene USP with 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and microcrystalline cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue No. 1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is soluble in formic acid. It is sparingly soluble in methoxyethanol. It is very slightly soluble in acetic acid, alcohol and dilute mineral acids. It is practically insoluble in water, benzene, ether, chloroform and dilute alkali hydroxides. Its molecular weight is 253.26. Its structural formula is. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is very slightly soluble in water. It is freely soluble in sodium hydroxide solution, n-butylamine and dimethyl formamide. It is sparingly soluble in methanol. It is insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.7. Its structural formula is:."
},
{
"NDCCode": "71335-1361-0",
"PackageDescription": "15 TABLET in 1 BOTTLE (71335-1361-0) ",
"NDC11Code": "71335-1361-00",
"ProductNDC": "71335-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240812",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "71335-1361-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (71335-1361-1) ",
"NDC11Code": "71335-1361-01",
"ProductNDC": "71335-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191119",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "71335-1361-2",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-1361-2) ",
"NDC11Code": "71335-1361-02",
"ProductNDC": "71335-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "71335-1361-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-1361-3) ",
"NDC11Code": "71335-1361-03",
"ProductNDC": "71335-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "71335-1361-4",
"PackageDescription": "56 TABLET in 1 BOTTLE (71335-1361-4) ",
"NDC11Code": "71335-1361-04",
"ProductNDC": "71335-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240812",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "71335-1361-5",
"PackageDescription": "100 TABLET in 1 BOTTLE (71335-1361-5) ",
"NDC11Code": "71335-1361-05",
"ProductNDC": "71335-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240812",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "71335-1361-6",
"PackageDescription": "120 TABLET in 1 BOTTLE (71335-1361-6) ",
"NDC11Code": "71335-1361-06",
"ProductNDC": "71335-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240812",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "71335-1361-8",
"PackageDescription": "40 TABLET in 1 BOTTLE (71335-1361-8) ",
"NDC11Code": "71335-1361-08",
"ProductNDC": "71335-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240812",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "71335-1361-9",
"PackageDescription": "20 TABLET in 1 BOTTLE (71335-1361-9) ",
"NDC11Code": "71335-1361-09",
"ProductNDC": "71335-1361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191018",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "48951-1026-7",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, GLASS (48951-1026-7)",
"NDC11Code": "48951-1026-07",
"ProductNDC": "48951-1026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amethyst Rosa Clear Skin",
"NonProprietaryName": "Amethyst Rosa Clear Skin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "SILICON DIOXIDE; ACTIVATED CHARCOAL; FUMARIA OFFICINALIS FLOWERING TOP; WORMWOOD; BETULA PUBESCENS LEAF; ACORUS CALAMUS ROOT; MATRICARIA RECUTITA; COCHLEARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GEUM URBANUM ROOT; OXALIS MONTANA LEAF; ROSA RUGOSA FLOWER BUD; URTICA DIOICA LEAF; URTICA DIOICA ROOT; GINGER; ANTIMONY TRISULFIDE; BLACK PEPPER; FERRIC OXIDE RED; GRAPHITE",
"StrengthNumber": "2; 2; 3; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 5; 5; 6; 17",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "48951-1096-1",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BAG (48951-1096-1) > 7 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "48951-1096-01",
"ProductNDC": "48951-1096",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Argentum Nitricum",
"NonProprietaryName": "Argentum Nitricum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "SILVER",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "48951-1102-1",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BAG (48951-1102-1) > 7 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "48951-1102-01",
"ProductNDC": "48951-1102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Argentum Viscum",
"NonProprietaryName": "Argentum Viscum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "SILVER CHLORIDE; VISCUM ALBUM FRUITING TOP; BOS TAURUS EYE",
"StrengthNumber": "6; 6; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "48951-1213-1",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (48951-1213-1) > 7 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "48951-1213-01",
"ProductNDC": "48951-1213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Rosa",
"NonProprietaryName": "Arnica Rosa",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "BOS TAURUS NERVE; BOS TAURUS EYE; BOS TAURUS BRAIN; ARNICA MONTANA; SILICON DIOXIDE",
"StrengthNumber": "6; 6; 7; 17; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "48951-1271-7",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, GLASS (48951-1271-7) ",
"NDC11Code": "48951-1271-07",
"ProductNDC": "48951-1271",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amethyst Rosa",
"NonProprietaryName": "Amethyst Rosa",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "ACORUS CALAMUS ROOT; ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; BETULA PUBESCENS LEAF; BLACK PEPPER; COCHLEARIA OFFICINALIS FLOWERING TOP; FERRIC OXIDE RED; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GEUM URBANUM ROOT; GINGER; GRAPHITE; MATRICARIA RECUTITA; OXALIS ACETOSELLA LEAF; ROSA RUGOSA FLOWER BUD; SILICON DIOXIDE; URTICA DIOICA LEAF; URTICA DIOICA ROOT; WORMWOOD",
"StrengthNumber": "4; 2; 5; 4; 5; 4; 6; 3; 4; 4; 4; 17; 4; 4; 4; 2; 4; 4; 4",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "48951-1298-1",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BAG (48951-1298-1) > 7 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "48951-1298-01",
"ProductNDC": "48951-1298",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aesculinum Comp. Special Order",
"NonProprietaryName": "Aesculinum Comp. Special Order",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "BOS TAURUS PLACENTA; BOS TAURUS NERVE; BOS TAURUS DIENCEPHALON; BOS TAURUS EYE; ESCULIN; BOS TAURUS FRONTAL LOBE; BOS TAURUS BRAIN; SUS SCROFA TEMPORAL LOBE",
"StrengthNumber": "8; 12; 12; 10; 6; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "48951-1357-7",
"PackageDescription": "75 g in 1 BOTTLE, GLASS (48951-1357-7) ",
"NDC11Code": "48951-1357-07",
"ProductNDC": "48951-1357",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amethyst Rosa",
"NonProprietaryName": "Amethyst Rosa",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy, Inc.",
"SubstanceName": "ACORUS CALAMUS ROOT; ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; BETULA PUBESCENS BARK; BLACK PEPPER; CHAMOMILE; COCHLEARIA OFFICINALIS FLOWERING TOP; FERRIC OXIDE RED; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GEUM URBANUM ROOT; GINGER; GRAPHITE; OXALIS STRICTA WHOLE; SEDUM ROSEUM WHOLE; SILICON DIOXIDE; URTICA DIOICA LEAF; URTICA DIOICA ROOT; WORMWOOD",
"StrengthNumber": "4; 2; 5; 4; 5; 4; 4; 6; 3; 4; 4; 4; 17; 4; 4; 2; 4; 4; 4",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "48951-1363-7",
"PackageDescription": "75 CAPSULE in 1 BOTTLE, GLASS (48951-1363-7) ",
"NDC11Code": "48951-1363-07",
"ProductNDC": "48951-1363",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amethyst Rosa",
"NonProprietaryName": "Amethyst Rosa",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy, Inc.",
"SubstanceName": "ACORUS CALAMUS ROOT; ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; BETULA PUBESCENS BARK; BLACK PEPPER; CHAMOMILE; COCHLEARIA OFFICINALIS FLOWERING TOP; FERRIC OXIDE RED; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GEUM URBANUM ROOT; GINGER; GRAPHITE; OXALIS STRICTA WHOLE; ROSA RUGOSA FLOWER; SEDUM ROSEUM WHOLE; SILICON DIOXIDE; URTICA DIOICA; WORMWOOD",
"StrengthNumber": "4; 2; 5; 4; 5; 4; 4; 6; 3; 4; 4; 4; 15; 4; 4; 4; 2; 4; 4",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "48951-2010-1",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BAG (48951-2010-1) > 7 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "48951-2010-01",
"ProductNDC": "48951-2010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bambusa Formica",
"NonProprietaryName": "Bambusa Formica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "MYRRH; FRANKINCENSE; BOS TAURUS CEREBELLUM; SILICON DIOXIDE; BOS TAURUS BRAIN; BOS TAURUS PITUITARY GLAND; BOS TAURUS EYE; SUS SCROFA THALAMUS; SILVER",
"StrengthNumber": "7; 7; 8; 8; 8; 8; 8; 8; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "48951-2027-1",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BAG (48951-2027-1) > 7 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "48951-2027-01",
"ProductNDC": "48951-2027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Belladonna Betula Formica",
"NonProprietaryName": "Belladonna Betula Formica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "BETULA PUBESCENS LEAF; ATROPA BELLADONNA; FORMICA RUFA",
"StrengthNumber": "3; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "48951-3024-7",
"PackageDescription": "1 POWDER in 1 BOTTLE, GLASS (48951-3024-7)",
"NDC11Code": "48951-3024-07",
"ProductNDC": "48951-3024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carbo Chamomilla Digestive Support",
"NonProprietaryName": "Activated Charcoal Artemisia Absinthium Flowering Top Matricaria Recutita Gentiana Lutea Root Avens Extract Black Pepper Ginger Antimony Trisulfide Arsenic Trioxide",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc",
"SubstanceName": "ACTIVATED CHARCOAL; ARTEMISIA ABSINTHIUM FLOWERING TOP; MATRICARIA RECUTITA; GENTIANA LUTEA ROOT; AVENS EXTRACT; BLACK PEPPER; GINGER; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE",
"StrengthNumber": "2; 3; 3; 3; 3; 3; 3; 3; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "48951-3046-1",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BAG (48951-3046-1) > 7 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "48951-3046-01",
"ProductNDC": "48951-3046",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Celandine Honey",
"NonProprietaryName": "Celandine Honey",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "CHELIDONIUM MAJUS; HONEY",
"StrengthNumber": "4; 4",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "48951-3073-7",
"PackageDescription": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (48951-3073-7) ",
"NDC11Code": "48951-3073-07",
"ProductNDC": "48951-3073",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chelidonium Cichorium",
"NonProprietaryName": "Chelidonium Cichorium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "BOS TAURUS GALLBLADDER; CHELIDONIUM MAJUS; CHICORY ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; IRON",
"StrengthNumber": "6; 4; 4; 4; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2023-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "48951-3080-1",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BAG (48951-3080-1) > 7 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "48951-3080-01",
"ProductNDC": "48951-3080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chelidonium Rosa",
"NonProprietaryName": "Chelidonium Rosa",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "FERRIC OXIDE RED; SEDUM ROSEUM WHOLE; CHELIDONIUM MAJUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; LARIX DECIDUA RESIN",
"StrengthNumber": "3; 3; 4; 4; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>48951-1361-7</NDCCode>
<PackageDescription>75 g in 1 BOTTLE, GLASS (48951-1361-7) </PackageDescription>
<NDC11Code>48951-1361-07</NDC11Code>
<ProductNDC>48951-1361</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amethyst Rosa</ProprietaryName>
<NonProprietaryName>Amethyst Rosa</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy, Inc.</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; FUMARIA OFFICINALIS FLOWERING TOP; GRAPHITE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>2; 5; 3; 15; 2</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-1361-7</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (71335-1361-7) </PackageDescription>
<NDC11Code>71335-1361-07</NDC11Code>
<ProductNDC>71335-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>67296-1361-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (67296-1361-3) </PackageDescription>
<NDC11Code>67296-1361-03</NDC11Code>
<ProductNDC>67296-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081297</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BENZONATATE is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. [Structure for Benzonatate]. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>70771-1361-0</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70771-1361-0) </PackageDescription>
<NDC11Code>70771-1361-00</NDC11Code>
<ProductNDC>70771-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208360</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>37.5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). .</IndicationAndUsage>
<Description>Triamterene and hydrochlorothiazide combines triamterene a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg contains. Triamterene, USP ..............................................................................37.5 mg. Hydrochlorothiazide, USP ................................................................25 mg. Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg contains. Triamterene, USP .............................................................................75 mg. Hydrochlorothiazide, USP ................................................................50 mg. Each triamterene and hydrochlorothiazide tablet, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP and 75 mg triamterene USP with 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and microcrystalline cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue No. 1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is soluble in formic acid. It is sparingly soluble in methoxyethanol. It is very slightly soluble in acetic acid, alcohol and dilute mineral acids. It is practically insoluble in water, benzene, ether, chloroform and dilute alkali hydroxides. Its molecular weight is 253.26. Its structural formula is. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is very slightly soluble in water. It is freely soluble in sodium hydroxide solution, n-butylamine and dimethyl formamide. It is sparingly soluble in methanol. It is insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.7. Its structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>70771-1361-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70771-1361-1) </PackageDescription>
<NDC11Code>70771-1361-01</NDC11Code>
<ProductNDC>70771-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208360</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>37.5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). .</IndicationAndUsage>
<Description>Triamterene and hydrochlorothiazide combines triamterene a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg contains. Triamterene, USP ..............................................................................37.5 mg. Hydrochlorothiazide, USP ................................................................25 mg. Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg contains. Triamterene, USP .............................................................................75 mg. Hydrochlorothiazide, USP ................................................................50 mg. Each triamterene and hydrochlorothiazide tablet, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP and 75 mg triamterene USP with 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and microcrystalline cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue No. 1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is soluble in formic acid. It is sparingly soluble in methoxyethanol. It is very slightly soluble in acetic acid, alcohol and dilute mineral acids. It is practically insoluble in water, benzene, ether, chloroform and dilute alkali hydroxides. Its molecular weight is 253.26. Its structural formula is. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is very slightly soluble in water. It is freely soluble in sodium hydroxide solution, n-butylamine and dimethyl formamide. It is sparingly soluble in methanol. It is insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.7. Its structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>70771-1361-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70771-1361-4) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70771-1361-04</NDC11Code>
<ProductNDC>70771-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208360</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>37.5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). .</IndicationAndUsage>
<Description>Triamterene and hydrochlorothiazide combines triamterene a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg contains. Triamterene, USP ..............................................................................37.5 mg. Hydrochlorothiazide, USP ................................................................25 mg. Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg contains. Triamterene, USP .............................................................................75 mg. Hydrochlorothiazide, USP ................................................................50 mg. Each triamterene and hydrochlorothiazide tablet, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP and 75 mg triamterene USP with 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and microcrystalline cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue No. 1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is soluble in formic acid. It is sparingly soluble in methoxyethanol. It is very slightly soluble in acetic acid, alcohol and dilute mineral acids. It is practically insoluble in water, benzene, ether, chloroform and dilute alkali hydroxides. Its molecular weight is 253.26. Its structural formula is. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is very slightly soluble in water. It is freely soluble in sodium hydroxide solution, n-butylamine and dimethyl formamide. It is sparingly soluble in methanol. It is insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.7. Its structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>70771-1361-5</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70771-1361-5) </PackageDescription>
<NDC11Code>70771-1361-05</NDC11Code>
<ProductNDC>70771-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208360</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>37.5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). .</IndicationAndUsage>
<Description>Triamterene and hydrochlorothiazide combines triamterene a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg contains. Triamterene, USP ..............................................................................37.5 mg. Hydrochlorothiazide, USP ................................................................25 mg. Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg contains. Triamterene, USP .............................................................................75 mg. Hydrochlorothiazide, USP ................................................................50 mg. Each triamterene and hydrochlorothiazide tablet, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP and 75 mg triamterene USP with 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and microcrystalline cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue No. 1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is soluble in formic acid. It is sparingly soluble in methoxyethanol. It is very slightly soluble in acetic acid, alcohol and dilute mineral acids. It is practically insoluble in water, benzene, ether, chloroform and dilute alkali hydroxides. Its molecular weight is 253.26. Its structural formula is. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is very slightly soluble in water. It is freely soluble in sodium hydroxide solution, n-butylamine and dimethyl formamide. It is sparingly soluble in methanol. It is insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.7. Its structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>71335-1361-0</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (71335-1361-0) </PackageDescription>
<NDC11Code>71335-1361-00</NDC11Code>
<ProductNDC>71335-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>71335-1361-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71335-1361-1) </PackageDescription>
<NDC11Code>71335-1361-01</NDC11Code>
<ProductNDC>71335-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>71335-1361-2</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-1361-2) </PackageDescription>
<NDC11Code>71335-1361-02</NDC11Code>
<ProductNDC>71335-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>71335-1361-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-1361-3) </PackageDescription>
<NDC11Code>71335-1361-03</NDC11Code>
<ProductNDC>71335-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>71335-1361-4</NDCCode>
<PackageDescription>56 TABLET in 1 BOTTLE (71335-1361-4) </PackageDescription>
<NDC11Code>71335-1361-04</NDC11Code>
<ProductNDC>71335-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>71335-1361-5</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71335-1361-5) </PackageDescription>
<NDC11Code>71335-1361-05</NDC11Code>
<ProductNDC>71335-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>71335-1361-6</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (71335-1361-6) </PackageDescription>
<NDC11Code>71335-1361-06</NDC11Code>
<ProductNDC>71335-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>71335-1361-8</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (71335-1361-8) </PackageDescription>
<NDC11Code>71335-1361-08</NDC11Code>
<ProductNDC>71335-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>71335-1361-9</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (71335-1361-9) </PackageDescription>
<NDC11Code>71335-1361-09</NDC11Code>
<ProductNDC>71335-1361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>48951-1026-7</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, GLASS (48951-1026-7)</PackageDescription>
<NDC11Code>48951-1026-07</NDC11Code>
<ProductNDC>48951-1026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amethyst Rosa Clear Skin</ProprietaryName>
<NonProprietaryName>Amethyst Rosa Clear Skin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>SILICON DIOXIDE; ACTIVATED CHARCOAL; FUMARIA OFFICINALIS FLOWERING TOP; WORMWOOD; BETULA PUBESCENS LEAF; ACORUS CALAMUS ROOT; MATRICARIA RECUTITA; COCHLEARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GEUM URBANUM ROOT; OXALIS MONTANA LEAF; ROSA RUGOSA FLOWER BUD; URTICA DIOICA LEAF; URTICA DIOICA ROOT; GINGER; ANTIMONY TRISULFIDE; BLACK PEPPER; FERRIC OXIDE RED; GRAPHITE</SubstanceName>
<StrengthNumber>2; 2; 3; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 5; 5; 6; 17</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>48951-1096-1</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BAG (48951-1096-1) > 7 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>48951-1096-01</NDC11Code>
<ProductNDC>48951-1096</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Argentum Nitricum</ProprietaryName>
<NonProprietaryName>Argentum Nitricum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>SILVER</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-1102-1</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BAG (48951-1102-1) > 7 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>48951-1102-01</NDC11Code>
<ProductNDC>48951-1102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Argentum Viscum</ProprietaryName>
<NonProprietaryName>Argentum Viscum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>SILVER CHLORIDE; VISCUM ALBUM FRUITING TOP; BOS TAURUS EYE</SubstanceName>
<StrengthNumber>6; 6; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-1213-1</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (48951-1213-1) > 7 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>48951-1213-01</NDC11Code>
<ProductNDC>48951-1213</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Rosa</ProprietaryName>
<NonProprietaryName>Arnica Rosa</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>BOS TAURUS NERVE; BOS TAURUS EYE; BOS TAURUS BRAIN; ARNICA MONTANA; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>6; 6; 7; 17; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-1271-7</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, GLASS (48951-1271-7) </PackageDescription>
<NDC11Code>48951-1271-07</NDC11Code>
<ProductNDC>48951-1271</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amethyst Rosa</ProprietaryName>
<NonProprietaryName>Amethyst Rosa</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>ACORUS CALAMUS ROOT; ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; BETULA PUBESCENS LEAF; BLACK PEPPER; COCHLEARIA OFFICINALIS FLOWERING TOP; FERRIC OXIDE RED; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GEUM URBANUM ROOT; GINGER; GRAPHITE; MATRICARIA RECUTITA; OXALIS ACETOSELLA LEAF; ROSA RUGOSA FLOWER BUD; SILICON DIOXIDE; URTICA DIOICA LEAF; URTICA DIOICA ROOT; WORMWOOD</SubstanceName>
<StrengthNumber>4; 2; 5; 4; 5; 4; 6; 3; 4; 4; 4; 17; 4; 4; 4; 2; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-1298-1</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BAG (48951-1298-1) > 7 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>48951-1298-01</NDC11Code>
<ProductNDC>48951-1298</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aesculinum Comp. Special Order</ProprietaryName>
<NonProprietaryName>Aesculinum Comp. Special Order</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>BOS TAURUS PLACENTA; BOS TAURUS NERVE; BOS TAURUS DIENCEPHALON; BOS TAURUS EYE; ESCULIN; BOS TAURUS FRONTAL LOBE; BOS TAURUS BRAIN; SUS SCROFA TEMPORAL LOBE</SubstanceName>
<StrengthNumber>8; 12; 12; 10; 6; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-1357-7</NDCCode>
<PackageDescription>75 g in 1 BOTTLE, GLASS (48951-1357-7) </PackageDescription>
<NDC11Code>48951-1357-07</NDC11Code>
<ProductNDC>48951-1357</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amethyst Rosa</ProprietaryName>
<NonProprietaryName>Amethyst Rosa</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy, Inc.</LabelerName>
<SubstanceName>ACORUS CALAMUS ROOT; ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; BETULA PUBESCENS BARK; BLACK PEPPER; CHAMOMILE; COCHLEARIA OFFICINALIS FLOWERING TOP; FERRIC OXIDE RED; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GEUM URBANUM ROOT; GINGER; GRAPHITE; OXALIS STRICTA WHOLE; SEDUM ROSEUM WHOLE; SILICON DIOXIDE; URTICA DIOICA LEAF; URTICA DIOICA ROOT; WORMWOOD</SubstanceName>
<StrengthNumber>4; 2; 5; 4; 5; 4; 4; 6; 3; 4; 4; 4; 17; 4; 4; 2; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-1363-7</NDCCode>
<PackageDescription>75 CAPSULE in 1 BOTTLE, GLASS (48951-1363-7) </PackageDescription>
<NDC11Code>48951-1363-07</NDC11Code>
<ProductNDC>48951-1363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amethyst Rosa</ProprietaryName>
<NonProprietaryName>Amethyst Rosa</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy, Inc.</LabelerName>
<SubstanceName>ACORUS CALAMUS ROOT; ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; BETULA PUBESCENS BARK; BLACK PEPPER; CHAMOMILE; COCHLEARIA OFFICINALIS FLOWERING TOP; FERRIC OXIDE RED; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GEUM URBANUM ROOT; GINGER; GRAPHITE; OXALIS STRICTA WHOLE; ROSA RUGOSA FLOWER; SEDUM ROSEUM WHOLE; SILICON DIOXIDE; URTICA DIOICA; WORMWOOD</SubstanceName>
<StrengthNumber>4; 2; 5; 4; 5; 4; 4; 6; 3; 4; 4; 4; 15; 4; 4; 4; 2; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>48951-2010-1</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BAG (48951-2010-1) > 7 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>48951-2010-01</NDC11Code>
<ProductNDC>48951-2010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bambusa Formica</ProprietaryName>
<NonProprietaryName>Bambusa Formica</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>MYRRH; FRANKINCENSE; BOS TAURUS CEREBELLUM; SILICON DIOXIDE; BOS TAURUS BRAIN; BOS TAURUS PITUITARY GLAND; BOS TAURUS EYE; SUS SCROFA THALAMUS; SILVER</SubstanceName>
<StrengthNumber>7; 7; 8; 8; 8; 8; 8; 8; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-2027-1</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BAG (48951-2027-1) > 7 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>48951-2027-01</NDC11Code>
<ProductNDC>48951-2027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Belladonna Betula Formica</ProprietaryName>
<NonProprietaryName>Belladonna Betula Formica</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>BETULA PUBESCENS LEAF; ATROPA BELLADONNA; FORMICA RUFA</SubstanceName>
<StrengthNumber>3; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-3024-7</NDCCode>
<PackageDescription>1 POWDER in 1 BOTTLE, GLASS (48951-3024-7)</PackageDescription>
<NDC11Code>48951-3024-07</NDC11Code>
<ProductNDC>48951-3024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carbo Chamomilla Digestive Support</ProprietaryName>
<NonProprietaryName>Activated Charcoal Artemisia Absinthium Flowering Top Matricaria Recutita Gentiana Lutea Root Avens Extract Black Pepper Ginger Antimony Trisulfide Arsenic Trioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ARTEMISIA ABSINTHIUM FLOWERING TOP; MATRICARIA RECUTITA; GENTIANA LUTEA ROOT; AVENS EXTRACT; BLACK PEPPER; GINGER; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>2; 3; 3; 3; 3; 3; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>48951-3046-1</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BAG (48951-3046-1) > 7 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>48951-3046-01</NDC11Code>
<ProductNDC>48951-3046</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Celandine Honey</ProprietaryName>
<NonProprietaryName>Celandine Honey</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>CHELIDONIUM MAJUS; HONEY</SubstanceName>
<StrengthNumber>4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-3073-7</NDCCode>
<PackageDescription>90 CAPSULE, LIQUID FILLED in 1 BOTTLE (48951-3073-7) </PackageDescription>
<NDC11Code>48951-3073-07</NDC11Code>
<ProductNDC>48951-3073</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chelidonium Cichorium</ProprietaryName>
<NonProprietaryName>Chelidonium Cichorium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>BOS TAURUS GALLBLADDER; CHELIDONIUM MAJUS; CHICORY ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; IRON</SubstanceName>
<StrengthNumber>6; 4; 4; 4; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-3080-1</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BAG (48951-3080-1) > 7 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>48951-3080-01</NDC11Code>
<ProductNDC>48951-3080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chelidonium Rosa</ProprietaryName>
<NonProprietaryName>Chelidonium Rosa</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>FERRIC OXIDE RED; SEDUM ROSEUM WHOLE; CHELIDONIUM MAJUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; LARIX DECIDUA RESIN</SubstanceName>
<StrengthNumber>3; 3; 4; 4; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>