{
"NDC": [
{
"NDCCode": "43386-543-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-543-05) ",
"NDC11Code": "43386-0543-05",
"ProductNDC": "43386-543",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203602",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151216",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1), 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. (1).",
"Description": "Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &C Blue #2 /Indigo carmine aluminum lake and FD&C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake and FD&C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD & C Blue # 2/ Indigo carmine aluminum lake, FD & C yellow # 6 /Sunset yellow. FCF aluminum lake and FD & C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "43386-543-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-543-01) ",
"NDC11Code": "43386-0543-01",
"ProductNDC": "43386-543",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203602",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151216",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &C Blue #2 /Indigo carmine aluminum lake and FD&C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake and FD&C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD & C Blue # 2/ Indigo carmine aluminum lake, FD & C yellow # 6 /Sunset yellow. FCF aluminum lake and FD & C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "16729-545-63",
"PackageDescription": "1 KIT in 1 CARTON (16729-545-63) * 3 mL in 1 VIAL (16729-544-85) * 20 mL in 1 VIAL, SINGLE-DOSE (16729-543-05) ",
"NDC11Code": "16729-0545-63",
"ProductNDC": "16729-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carmustine",
"NonProprietaryName": "Carmustine",
"DosageFormName": "KIT",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215000",
"LabelerName": "Accord Healthcare Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220818",
"SamplePackage": "N",
"IndicationAndUsage": "Carmustine for Injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: : 1 Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. , 2 Multiple myeloma in combination with prednisone. , 3 Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs., 4 Relapsed or refractory non-Hodgkin's lymphomas in combination with other approved drugs.",
"Description": "Carmustine is a nitrosourea with the chemical name 1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.05. The drug product is supplied as sterile lyophilized pale yellow dry flakes or dry congealed mass, and it is highly soluble in alcohol and lipids, and poorly soluble in water. Carmustine for Injection is administered by intravenous infusion after reconstitution with 10% Dehydrated Alcohol Injection and dilution with 0.9% Sodium Chloride Injection or 5% Dextrose Injection, as recommended. The structural formula of carmustine is. Carmustine for Injection is available in 50-mg single dose vial and 300-mg single dose vial of lyophilized material. Sterile diluent for constitution of Carmustine for Injection is co-packaged with the active drug product for use in constitution of the lyophile. Diluent vial containing 3 mL of Dehydrated Alcohol Injection and 9 mL of Dehydrated Alcohol Injection, is supplied along with drug product vial containing 50 mg of carmustine and 300 mg of carmustine respectively. Amount of dehydrated alcohol after reconstitution is 10% v/v, or 1185 mg and 7110 mg for 50 mg carmustine and 300 mg vials, respectively."
},
{
"NDCCode": "31722-543-05",
"PackageDescription": "12 BOTTLE in 1 CASE (31722-543-05) / 500 CAPSULE in 1 BOTTLE",
"NDC11Code": "31722-0543-05",
"ProductNDC": "31722-543",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091240",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160519",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis.",
"Description": "Indomethacin capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 25 mg or 50 mg of indomethacin USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19H 16ClNO 4, and it has the following chemical structure. Indomethacin USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, in chloroform and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin capsules USP, 25 mg or 50 mg include: lactose monohydrate, sodium lauryl sulfate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, FD & C Blue 1, D & C Yellow 10. The capsules are printed with black ink containing black iron oxide E172 dye."
},
{
"NDCCode": "40032-543-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-543-05) ",
"NDC11Code": "40032-0543-05",
"ProductNDC": "40032-543",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203602",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151216",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1), 2 Morphine sulfate extended-release tablets is not indicated as an as-needed (prn) analgesic. (1).",
"Description": "Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &C Blue #2 /Indigo carmine aluminum lake and FD&C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake and FD&C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD & C Blue # 2/ Indigo carmine aluminum lake, FD & C yellow # 6 /Sunset yellow. FCF aluminum lake and FD & C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "59746-543-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (59746-543-05) ",
"NDC11Code": "59746-0543-05",
"ProductNDC": "59746-543",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205407",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151223",
"SamplePackage": "N"
},
{
"NDCCode": "60429-543-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (60429-543-05)",
"NDC11Code": "60429-0543-05",
"ProductNDC": "60429-543",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flurazepam",
"NonProprietaryName": "Flurazepam Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19861208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071108",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "FLURAZEPAM HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2017-10-26"
},
{
"NDCCode": "64764-543-05",
"PackageDescription": "5 BLISTER PACK in 1 TRAY (64764-543-05) / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "64764-0543-05",
"ProductNDC": "64764-543",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prevacid Solutab",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20020830",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021428",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020830",
"SamplePackage": "N",
"IndicationAndUsage": "PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. PREVACID is supplied in delayed-release capsules and PREVACID SoluTab is supplied in delayed-release orally disintegrating tablets (SoluTab) for oral administration. PREVACID is available in one dosage strength: 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40. The 15 mg strength of PREVACID is not currently marketed by Takeda Pharmaceuticals America, Inc. PREVACID SoluTab is available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartamePhenylketonurics: PREVACID SoluTab Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet., glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide."
},
{
"NDCCode": "68428-543-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-543-05) ",
"NDC11Code": "68428-0543-05",
"ProductNDC": "68428-543",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oophorinum",
"NonProprietaryName": "Sus Scrofa Ovary",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100810",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SUS SCROFA OVARY",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100810",
"SamplePackage": "N"
},
{
"NDCCode": "70934-543-05",
"PackageDescription": "5 TABLET in 1 BOTTLE, PLASTIC (70934-543-05) ",
"NDC11Code": "70934-0543-05",
"ProductNDC": "70934-543",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200210",
"EndMarketingDate": "20230430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210525",
"LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200210",
"EndMarketingDatePackage": "20230430",
"SamplePackage": "N"
},
{
"NDCCode": "84827-543-05",
"PackageDescription": "100 mL in 1 BOTTLE (84827-543-05) ",
"NDC11Code": "84827-0543-05",
"ProductNDC": "84827-543",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "100% Sweet Almond Oil",
"NonProprietaryName": "100% Sweet Almond Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "43386-022-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-022-05) ",
"NDC11Code": "43386-0022-05",
"ProductNDC": "43386-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207526",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160822",
"SamplePackage": "N",
"IndicationAndUsage": "Linezolid tablets are an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections (1.5). Limitations of Use (1.6): 1 Linezolid Tablets are not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled, 3 clinical trials.",
"Description": "Linezolid Tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4- morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:. Linezolid tablets for oral administration contain 600 mg linezolid, supplied as white, oval, film-coated tablets, debossed with \"n 022\" on one side and plain on other side. Inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidine, magnesium stearate, titanium dioxide, polydextrose, hypromellose, triacetin, and polyethylene glycol."
},
{
"NDCCode": "43386-088-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43386-088-05) ",
"NDC11Code": "43386-0088-05",
"ProductNDC": "43386-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207371",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160524",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin."
},
{
"NDCCode": "43386-089-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43386-089-05) ",
"NDC11Code": "43386-0089-05",
"ProductNDC": "43386-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207371",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160524",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin."
},
{
"NDCCode": "43386-118-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-118-05) ",
"NDC11Code": "43386-0118-05",
"ProductNDC": "43386-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091528",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE",
"StrengthNumber": "1.5; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140923",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone Bitartrate and Homatropine Methylbromide Tablets are indicated for the symptomatic relief of cough in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ]., 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4) ]., 3 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.",
"Description": "Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP contains hydrocodone an opioid agonist, and homatropine a muscarinic antagonist. Each tablet of Hydrocodone Bitartrate and Homatropine Methylbromide contains 5 mg of Hydrocodone Bitartrate, USP and 1.5 mg of Homatropine Methylbromide, USP for oral administartion. Hydrocodone Bitartrate and Homatropine Methylbromide Tablets also contains the following inactive ingredients: anhydrous lactose, dicalcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate. Hydrocodone Bitartrate. The chemical name for hydrocodone bitartrate is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one-tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8- Azoniabicyclo[3.2.1]octane, 3-[(hydroxyphenyl-acetyl)oxy]-8, 8-dimethyl-,bromide,endo. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure. C17H24BrNO3."
},
{
"NDCCode": "43386-350-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-350-05)",
"NDC11Code": "43386-0350-05",
"ProductNDC": "43386-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091528",
"LabelerName": "GAVIS Pharmaceuticals, LLC",
"SubstanceName": "HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE",
"StrengthNumber": "1.5; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-09-26"
},
{
"NDCCode": "43386-351-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-351-05) ",
"NDC11Code": "43386-0351-05",
"ProductNDC": "43386-351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206142",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161114",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "43386-352-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-352-05) ",
"NDC11Code": "43386-0352-05",
"ProductNDC": "43386-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206142",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161114",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "43386-353-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-353-05) ",
"NDC11Code": "43386-0353-05",
"ProductNDC": "43386-353",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206142",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161114",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "43386-356-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-356-05) ",
"NDC11Code": "43386-0356-05",
"ProductNDC": "43386-356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206245",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2."
},
{
"NDCCode": "43386-357-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-357-05) ",
"NDC11Code": "43386-0357-05",
"ProductNDC": "43386-357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206245",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2."
},
{
"NDCCode": "43386-358-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-358-05) ",
"NDC11Code": "43386-0358-05",
"ProductNDC": "43386-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206245",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2."
},
{
"NDCCode": "43386-430-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-430-05) ",
"NDC11Code": "43386-0430-05",
"ProductNDC": "43386-430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204021",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170612",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white to off-white, fine 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. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "43386-431-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-431-05) ",
"NDC11Code": "43386-0431-05",
"ProductNDC": "43386-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204021",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170612",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white to off-white, fine 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. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "43386-432-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-432-05) ",
"NDC11Code": "43386-0432-05",
"ProductNDC": "43386-432",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204021",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170612",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white to off-white, fine 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. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "43386-433-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-433-05) ",
"NDC11Code": "43386-0433-05",
"ProductNDC": "43386-433",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204021",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170612",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white to off-white, fine 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. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "43386-434-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-434-05) ",
"NDC11Code": "43386-0434-05",
"ProductNDC": "43386-434",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204021",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170612",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white to off-white, fine 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. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "43386-490-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-490-05) ",
"NDC11Code": "43386-0490-05",
"ProductNDC": "43386-490",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204407",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170224",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen 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 [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP.................................................................. 2.5 mg*. (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 5 mg*. (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 7.5 mg*. (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 10 mg*. (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. C18H21NO4 ·HCl MW 351.82. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. C8H9NO2 MW 151.16."
},
{
"NDCCode": "43386-491-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-491-05) ",
"NDC11Code": "43386-0491-05",
"ProductNDC": "43386-491",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204407",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170224",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen 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 [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP.................................................................. 2.5 mg*. (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 5 mg*. (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 7.5 mg*. (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 10 mg*. (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. C18H21NO4 ·HCl MW 351.82. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. C8H9NO2 MW 151.16."
},
{
"NDCCode": "43386-492-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43386-492-05) ",
"NDC11Code": "43386-0492-05",
"ProductNDC": "43386-492",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204407",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170224",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen 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 [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP.................................................................. 2.5 mg*. (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 5 mg*. (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 7.5 mg*. (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 10 mg*. (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. C18H21NO4 ·HCl MW 351.82. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. C8H9NO2 MW 151.16."
}
]
}
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<NDCList>
<NDC>
<NDCCode>43386-543-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-543-05) </PackageDescription>
<NDC11Code>43386-0543-05</NDC11Code>
<ProductNDC>43386-543</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203602</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1), 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. (1).</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &C Blue #2 /Indigo carmine aluminum lake and FD&C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake and FD&C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD & C Blue # 2/ Indigo carmine aluminum lake, FD & C yellow # 6 /Sunset yellow. FCF aluminum lake and FD & C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>43386-543-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-543-01) </PackageDescription>
<NDC11Code>43386-0543-01</NDC11Code>
<ProductNDC>43386-543</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203602</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &C Blue #2 /Indigo carmine aluminum lake and FD&C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake and FD&C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD & C Blue # 2/ Indigo carmine aluminum lake, FD & C yellow # 6 /Sunset yellow. FCF aluminum lake and FD & C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>16729-545-63</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (16729-545-63) * 3 mL in 1 VIAL (16729-544-85) * 20 mL in 1 VIAL, SINGLE-DOSE (16729-543-05) </PackageDescription>
<NDC11Code>16729-0545-63</NDC11Code>
<ProductNDC>16729-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carmustine</ProprietaryName>
<NonProprietaryName>Carmustine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215000</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carmustine for Injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: : 1 Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. , 2 Multiple myeloma in combination with prednisone. , 3 Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs., 4 Relapsed or refractory non-Hodgkin's lymphomas in combination with other approved drugs.</IndicationAndUsage>
<Description>Carmustine is a nitrosourea with the chemical name 1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.05. The drug product is supplied as sterile lyophilized pale yellow dry flakes or dry congealed mass, and it is highly soluble in alcohol and lipids, and poorly soluble in water. Carmustine for Injection is administered by intravenous infusion after reconstitution with 10% Dehydrated Alcohol Injection and dilution with 0.9% Sodium Chloride Injection or 5% Dextrose Injection, as recommended. The structural formula of carmustine is. Carmustine for Injection is available in 50-mg single dose vial and 300-mg single dose vial of lyophilized material. Sterile diluent for constitution of Carmustine for Injection is co-packaged with the active drug product for use in constitution of the lyophile. Diluent vial containing 3 mL of Dehydrated Alcohol Injection and 9 mL of Dehydrated Alcohol Injection, is supplied along with drug product vial containing 50 mg of carmustine and 300 mg of carmustine respectively. Amount of dehydrated alcohol after reconstitution is 10% v/v, or 1185 mg and 7110 mg for 50 mg carmustine and 300 mg vials, respectively.</Description>
</NDC>
<NDC>
<NDCCode>31722-543-05</NDCCode>
<PackageDescription>12 BOTTLE in 1 CASE (31722-543-05) / 500 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0543-05</NDC11Code>
<ProductNDC>31722-543</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091240</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 25 mg or 50 mg of indomethacin USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19H 16ClNO 4, and it has the following chemical structure. Indomethacin USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, in chloroform and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin capsules USP, 25 mg or 50 mg include: lactose monohydrate, sodium lauryl sulfate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, FD & C Blue 1, D & C Yellow 10. The capsules are printed with black ink containing black iron oxide E172 dye.</Description>
</NDC>
<NDC>
<NDCCode>40032-543-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-543-05) </PackageDescription>
<NDC11Code>40032-0543-05</NDC11Code>
<ProductNDC>40032-543</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203602</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1), 2 Morphine sulfate extended-release tablets is not indicated as an as-needed (prn) analgesic. (1).</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &C Blue #2 /Indigo carmine aluminum lake and FD&C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake and FD&C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD & C Blue # 2/ Indigo carmine aluminum lake, FD & C yellow # 6 /Sunset yellow. FCF aluminum lake and FD & C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&C Yellow #10 aluminum lake and FD&C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>59746-543-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59746-543-05) </PackageDescription>
<NDC11Code>59746-0543-05</NDC11Code>
<ProductNDC>59746-543</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205407</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60429-543-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (60429-543-05)</PackageDescription>
<NDC11Code>60429-0543-05</NDC11Code>
<ProductNDC>60429-543</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flurazepam</ProprietaryName>
<NonProprietaryName>Flurazepam Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071108</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>FLURAZEPAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-10-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>64764-543-05</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 TRAY (64764-543-05) / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0543-05</NDC11Code>
<ProductNDC>64764-543</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prevacid Solutab</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020830</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021428</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. PREVACID is supplied in delayed-release capsules and PREVACID SoluTab is supplied in delayed-release orally disintegrating tablets (SoluTab) for oral administration. PREVACID is available in one dosage strength: 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40. The 15 mg strength of PREVACID is not currently marketed by Takeda Pharmaceuticals America, Inc. PREVACID SoluTab is available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartamePhenylketonurics: PREVACID SoluTab Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet., glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>68428-543-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-543-05) </PackageDescription>
<NDC11Code>68428-0543-05</NDC11Code>
<ProductNDC>68428-543</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oophorinum</ProprietaryName>
<NonProprietaryName>Sus Scrofa Ovary</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100810</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SUS SCROFA OVARY</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70934-543-05</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE, PLASTIC (70934-543-05) </PackageDescription>
<NDC11Code>70934-0543-05</NDC11Code>
<ProductNDC>70934-543</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200210</StartMarketingDate>
<EndMarketingDate>20230430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210525</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200210</StartMarketingDatePackage>
<EndMarketingDatePackage>20230430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84827-543-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84827-543-05) </PackageDescription>
<NDC11Code>84827-0543-05</NDC11Code>
<ProductNDC>84827-543</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>100% Sweet Almond Oil</ProprietaryName>
<NonProprietaryName>100% Sweet Almond Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43386-022-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-022-05) </PackageDescription>
<NDC11Code>43386-0022-05</NDC11Code>
<ProductNDC>43386-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207526</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Linezolid tablets are an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections (1.5). Limitations of Use (1.6): 1 Linezolid Tablets are not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled, 3 clinical trials.</IndicationAndUsage>
<Description>Linezolid Tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4- morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:. Linezolid tablets for oral administration contain 600 mg linezolid, supplied as white, oval, film-coated tablets, debossed with "n 022" on one side and plain on other side. Inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidine, magnesium stearate, titanium dioxide, polydextrose, hypromellose, triacetin, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>43386-088-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43386-088-05) </PackageDescription>
<NDC11Code>43386-0088-05</NDC11Code>
<ProductNDC>43386-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207371</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>43386-089-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43386-089-05) </PackageDescription>
<NDC11Code>43386-0089-05</NDC11Code>
<ProductNDC>43386-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207371</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>43386-118-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-118-05) </PackageDescription>
<NDC11Code>43386-0118-05</NDC11Code>
<ProductNDC>43386-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091528</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>1.5; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone Bitartrate and Homatropine Methylbromide Tablets are indicated for the symptomatic relief of cough in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ]., 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4) ]., 3 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP contains hydrocodone an opioid agonist, and homatropine a muscarinic antagonist. Each tablet of Hydrocodone Bitartrate and Homatropine Methylbromide contains 5 mg of Hydrocodone Bitartrate, USP and 1.5 mg of Homatropine Methylbromide, USP for oral administartion. Hydrocodone Bitartrate and Homatropine Methylbromide Tablets also contains the following inactive ingredients: anhydrous lactose, dicalcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate. Hydrocodone Bitartrate. The chemical name for hydrocodone bitartrate is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one-tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8- Azoniabicyclo[3.2.1]octane, 3-[(hydroxyphenyl-acetyl)oxy]-8, 8-dimethyl-,bromide,endo. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure. C17H24BrNO3.</Description>
</NDC>
<NDC>
<NDCCode>43386-350-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-350-05)</PackageDescription>
<NDC11Code>43386-0350-05</NDC11Code>
<ProductNDC>43386-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091528</ApplicationNumber>
<LabelerName>GAVIS Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>1.5; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>43386-351-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-351-05) </PackageDescription>
<NDC11Code>43386-0351-05</NDC11Code>
<ProductNDC>43386-351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206142</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43386-352-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-352-05) </PackageDescription>
<NDC11Code>43386-0352-05</NDC11Code>
<ProductNDC>43386-352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206142</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43386-353-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-353-05) </PackageDescription>
<NDC11Code>43386-0353-05</NDC11Code>
<ProductNDC>43386-353</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206142</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43386-356-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-356-05) </PackageDescription>
<NDC11Code>43386-0356-05</NDC11Code>
<ProductNDC>43386-356</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206245</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43386-357-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-357-05) </PackageDescription>
<NDC11Code>43386-0357-05</NDC11Code>
<ProductNDC>43386-357</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206245</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43386-358-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-358-05) </PackageDescription>
<NDC11Code>43386-0358-05</NDC11Code>
<ProductNDC>43386-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206245</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are 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 dosages or duration [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43386-430-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-430-05) </PackageDescription>
<NDC11Code>43386-0430-05</NDC11Code>
<ProductNDC>43386-430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204021</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white to off-white, fine 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. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>43386-431-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-431-05) </PackageDescription>
<NDC11Code>43386-0431-05</NDC11Code>
<ProductNDC>43386-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204021</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white to off-white, fine 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. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>43386-432-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-432-05) </PackageDescription>
<NDC11Code>43386-0432-05</NDC11Code>
<ProductNDC>43386-432</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204021</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</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>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white to off-white, fine 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. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>43386-433-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-433-05) </PackageDescription>
<NDC11Code>43386-0433-05</NDC11Code>
<ProductNDC>43386-433</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204021</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white to off-white, fine 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. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>43386-434-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-434-05) </PackageDescription>
<NDC11Code>43386-0434-05</NDC11Code>
<ProductNDC>43386-434</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204021</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white to off-white, fine 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. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>43386-490-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-490-05) </PackageDescription>
<NDC11Code>43386-0490-05</NDC11Code>
<ProductNDC>43386-490</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204407</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen 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 [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP.................................................................. 2.5 mg*. (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 5 mg*. (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 7.5 mg*. (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 10 mg*. (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. C18H21NO4 ·HCl MW 351.82. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. C8H9NO2 MW 151.16.</Description>
</NDC>
<NDC>
<NDCCode>43386-491-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-491-05) </PackageDescription>
<NDC11Code>43386-0491-05</NDC11Code>
<ProductNDC>43386-491</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204407</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen 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 [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP.................................................................. 2.5 mg*. (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 5 mg*. (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 7.5 mg*. (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 10 mg*. (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. C18H21NO4 ·HCl MW 351.82. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. C8H9NO2 MW 151.16.</Description>
</NDC>
<NDC>
<NDCCode>43386-492-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43386-492-05) </PackageDescription>
<NDC11Code>43386-0492-05</NDC11Code>
<ProductNDC>43386-492</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204407</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen 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 [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP.................................................................. 2.5 mg*. (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 5 mg*. (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 7.5 mg*. (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. Oxycodone Hydrochloride, USP.................................................................. 10 mg*. (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone). Acetaminophen, USP...................................................................................... 325 mg. All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. C18H21NO4 ·HCl MW 351.82. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. C8H9NO2 MW 151.16.</Description>
</NDC>
</NDCList>