{
"NDC": [
{
"NDCCode": "55700-484-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (55700-484-12)",
"NDC11Code": "55700-0484-12",
"ProductNDC": "55700-484",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "43598-484-12",
"PackageDescription": "5 BOTTLE in 1 CARTON (43598-484-12) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0484-12",
"ProductNDC": "43598-484",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20200911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212983",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200911",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "62559-484-12",
"PackageDescription": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-484-12) ",
"NDC11Code": "62559-0484-12",
"ProductNDC": "62559-484",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076697",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260413",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine extended-release capsules are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 1.Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types., 2 2.Generalized tonic-clonic seizures (grand mal)., 3 3.Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
"Description": "Carbamazepine extended-release capsules are an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f] azepine-5-carboxamide, and its structural formula is. Carbamazepine extended-release capsules contain a single type of beads designed to provide twice daily dosing of carbamazepine. The inactive ingredients contained in carbamazepine extended-release capsules are:Ethylcellulose, medium chain triglycerides, oleic acid, hypromellose, polyethylene glycol, microcrystalline cellulose, colloidal silicon dioxide, and sodium lauryl sulfate. In addition: 1 The 100 mg capsule shell contains gelatin, titanium dioxide, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, and is imprinted with black ink., 2 The 200 mg capsule shell contains gelatin, titanium dioxide, D&C Yellow #10, and is imprinted with black ink., 3 The 300 mg capsule shell contains gelatin, titanium dioxide, D&C Red #28, FD&C Blue #1, black iron oxide, and is imprinted with black ink."
},
{
"NDCCode": "68428-484-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-484-12) ",
"NDC11Code": "68428-0484-12",
"ProductNDC": "68428-484",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Luffa Operculata",
"NonProprietaryName": "Luffa Operculata Fruit",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "LUFFA OPERCULATA FRUIT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "55700-484-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (55700-484-10)",
"NDC11Code": "55700-0484-10",
"ProductNDC": "55700-484",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55700-484-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (55700-484-20)",
"NDC11Code": "55700-0484-20",
"ProductNDC": "55700-484",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55700-484-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (55700-484-30)",
"NDC11Code": "55700-0484-30",
"ProductNDC": "55700-484",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55700-004-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-004-12)",
"NDC11Code": "55700-0004-12",
"ProductNDC": "55700-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077797",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "55700-044-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (55700-044-12)",
"NDC11Code": "55700-0044-12",
"ProductNDC": "55700-044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55700-044-40",
"PackageDescription": "12 TABLET in 1 BOTTLE (55700-044-40)",
"NDC11Code": "55700-0044-40",
"ProductNDC": "55700-044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55700-064-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (55700-064-12)",
"NDC11Code": "55700-0064-12",
"ProductNDC": "55700-064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55700-221-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (55700-221-12) ",
"NDC11Code": "55700-0221-12",
"ProductNDC": "55700-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150218",
"SamplePackage": "N"
},
{
"NDCCode": "55700-229-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-229-12)",
"NDC11Code": "55700-0229-12",
"ProductNDC": "55700-229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077797",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55700-261-12",
"PackageDescription": "12 TABLET in 1 BOTTLE, PLASTIC (55700-261-12) ",
"NDC11Code": "55700-0261-12",
"ProductNDC": "55700-261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040655",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151113",
"SamplePackage": "N"
},
{
"NDCCode": "55700-311-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (55700-311-12)",
"NDC11Code": "55700-0311-12",
"ProductNDC": "55700-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55700-412-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (55700-412-12) ",
"NDC11Code": "55700-0412-12",
"ProductNDC": "55700-412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091498",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160603",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated for the management of moderate to moderately severe pain in adults.",
"Description": "Tramadol hydrochloride tablets, USP, is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "55700-627-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (55700-627-12) ",
"NDC11Code": "55700-0627-12",
"ProductNDC": "55700-627",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180518",
"EndMarketingDate": "20280131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078539",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180518",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6."
},
{
"NDCCode": "55700-652-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (55700-652-12) ",
"NDC11Code": "55700-0652-12",
"ProductNDC": "55700-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209037",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180713",
"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 UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [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 is 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, USP 5 mg/300 mg contains. Hydrocodone Bitartrate. . . . . . . . 5 mgAcetaminophen. . . . . . . . . . . . . .300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/300 mg contains. Hydrocodone Bitartrate. . . . . . . . .7.5 mgAcetaminophen. . . . . . . . . . . . . . 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/300 mg contains. Hydrocodone Bitartrate. . . . . . . . 10 mgAcetaminophen. . . . . . . . . . . . . .300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 5 mg/325 mg contains. Hydrocodone Bitartrate. . . . . . . . 5 mgAcetaminophen. . . . . . . . . . . . . .325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/325 mg contains. Hydrocodone Bitartrate. . . . . . . . .7.5 mgAcetaminophen. . . . . . . . . . . . . . 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/325 mg contains. Hydrocodone Bitartrate. . . . . . . . 10 mgAcetaminophen. . . . . . . . . . . . . .325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg: This product complies with USP dissolution test 2. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg: This product complies with USP dissolution test 1."
},
{
"NDCCode": "55700-771-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (55700-771-12) ",
"NDC11Code": "55700-0771-12",
"ProductNDC": "55700-771",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211487",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190628",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets, USP 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], reserve hydrocodone bitartrate and acetaminophen tablets, USP 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, USP is 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 Bitartate and Acetaminophen Tablet, USP contains. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide, crospovidone, pregelatinized starch, povidone, FD&C Yellow No 6 (for strength 5mg/325 mg), D&C Yellow No 10 (for strength 10 mg/325 mg) and stearic acid. Hydrocodone Bitartrate and Acetaminophen Tablets, USP complies to USP Dissolution Test 1."
},
{
"NDCCode": "55700-920-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (55700-920-12) ",
"NDC11Code": "55700-0920-12",
"ProductNDC": "55700-920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209587",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE",
"StrengthNumber": "325; 50; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210910",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients. Inactive Ingredients: silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula."
},
{
"NDCCode": "55700-961-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (55700-961-12) ",
"NDC11Code": "55700-0961-12",
"ProductNDC": "55700-961",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220131",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088481",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220131",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis and serum sickness.",
"Description": "Dexamethasone Tablets 0.5 mg, 0.75 mg, 4 mg and 6 mg are for oral administration. Each tablet contains 0.5 mg, 0.75 mg, 4 mg or 6 mg of dexamethasone. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 0.5 mg tablet contains D&C Yellow #10. The 0.75 mg tablet contains D&C Yellow #10 and FD&C Blue #1."
},
{
"NDCCode": "0121-0759-08",
"PackageDescription": "237 mL in 1 BOTTLE (0121-0759-08) ",
"NDC11Code": "00121-0759-08",
"ProductNDC": "0121-0759",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone Sodium Phosphate",
"NonProprietaryName": "Prednisolone Sodium Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20050425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076913",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "PREDNISOLONE SODIUM PHOSPHATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050425",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisolone sodium phosphate oral solution is indicated in the following conditions:.",
"Description": "Prednisolone Sodium Phosphate Oral Solution is a dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base) in a palatable, aqueous vehicle. Inactive ingredients: Prednisolone Sodium Phosphate Oral Solution equivalent to 15 mg prednisolone per 5 mL contains the following inactive ingredients: anti-bitter mask, edetate disodium, glycerin, grape flavor, high fructose corn syrup, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic, potassium phosphate monobasic, purified water, and saccharin sodium. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)-,disodium salt, (11β)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. Its chemical structure is. Pharmacological Category: Glucocorticoid."
},
{
"NDCCode": "0121-0902-04",
"PackageDescription": "120 mL in 1 BOTTLE (0121-0902-04) ",
"NDC11Code": "00121-0902-04",
"ProductNDC": "0121-0902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone Sodium Phosphate",
"NonProprietaryName": "Prednisolone Sodium Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20040525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075988",
"LabelerName": "Pharmaceutical Associates, Inc.",
"SubstanceName": "PREDNISOLONE SODIUM PHOSPHATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210510",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisolone sodium phosphate oral solution is indicated in the following conditions. 1. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States. To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia. 4. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 5. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis. 6. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia. 7. Neoplastic Diseases. For the treatment of acute leukemia and aggressive lymphomas in adults and children. 8. Nervous System. Acute exacerbations of multiple sclerosis. 9. Ophthalmic Diseases. Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia. 10. Respiratory Diseases. Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “Allergic States”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia. 11. Rheumatic Disorders. As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); Trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).",
"Description": "Prednisolone sodium phosphate oral solution is a dye free, clear, colorless to slightly yellow colored, raspberry flavored solution. Each 5 mL (teaspoonful) of prednisolone sodium phosphate oral solution contains 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) in a palatable, aqueous vehicle. Prednisolone sodium phosphate oral solution also contains edetate disodium, methylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sorbitol solution, and artificial raspberry flavor. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)-,disodium salt,(11β)-. The empirical formula is C 21H 27Na 2O 8P; the molecular weight is 484.39. Its chemical structure is. Pharmacological Category: Glucocorticoid."
},
{
"NDCCode": "0121-1100-04",
"PackageDescription": "5 mL in 1 BOTTLE (0121-1100-04) ",
"NDC11Code": "00121-1100-04",
"ProductNDC": "0121-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone Sodium Phosphate",
"NonProprietaryName": "Prednisolone Sodium Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260626",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019157",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "PREDNISOLONE SODIUM PHOSPHATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260626",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions. 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides.3. Edematous States To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia.4. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.5. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis.6. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia.7. Neoplastic Diseases For the treatment of acute leukemia and aggressive lymphomas in adults and children.8. Nervous System Acute exacerbations of multiple sclerosis.9. Ophthalmic Diseases Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia.10. Respiratory Diseases Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “Allergic States”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti- PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia.11. Rheumatic DisordersAs adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis.12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); Trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).",
"Description": "Prednisolone Sodium Phosphate Oral Solution is a dye free, colorless to light strawcolored, raspberry flavored solution. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) in a palatable, aqueous vehicle. Prednisolone Sodium Phosphate Oral Solution also contains dibasic sodium phosphate, edetate disodium, methylparaben, purified water, sodium biphosphate, sorbitol, natural and artificial raspberry flavor. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)-,disodium salt,(11β)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. The chemical structure is:. Pharmacological Category: Glucocorticoid."
},
{
"NDCCode": "0121-4759-50",
"PackageDescription": "5 TRAY in 1 CASE (0121-4759-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4759-05) ",
"NDC11Code": "00121-4759-50",
"ProductNDC": "0121-4759",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone Sodium Phosphate",
"NonProprietaryName": "Prednisolone Sodium Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076913",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "PREDNISOLONE SODIUM PHOSPHATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240322",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisolone sodium phosphate oral solution is indicated in the following conditions:.",
"Description": "Prednisolone Sodium Phosphate Oral Solution is a dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base) in a palatable, aqueous vehicle. Inactive ingredients: Prednisolone Sodium Phosphate Oral Solution equivalent to 15 mg prednisolone per 5 mL contains the following inactive ingredients: anti-bitter mask, edetate disodium, glycerin, grape flavor, high fructose corn syrup, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic, potassium phosphate monobasic, purified water, and saccharin sodium. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)-,disodium salt, (11β)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. Its chemical structure is. Pharmacological Category: Glucocorticoid."
},
{
"NDCCode": "0187-0653-01",
"PackageDescription": "1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE",
"NDC11Code": "00187-0653-01",
"ProductNDC": "0187-0653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duobrii",
"NonProprietaryName": "Halobetasol Propionate And Tazarotene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190425",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209354",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "HALOBETASOL PROPIONATE; TAZAROTENE",
"StrengthNumber": ".1; .45",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2023-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190425",
"SamplePackage": "N",
"IndicationAndUsage": "DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults.",
"Description": "DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients in a white to off-white lotion formulation intended for topical use. Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is [(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate. The structural formula for halobetasol propionate is represented below. Molecular Formula: C25H31ClF2O5 Molecular Weight: 484.96. Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below. Molecular Formula: C21H21NO2S Molecular Weight: 351.46. Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%."
},
{
"NDCCode": "0187-0653-03",
"PackageDescription": "6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE",
"NDC11Code": "00187-0653-03",
"ProductNDC": "0187-0653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duobrii",
"NonProprietaryName": "Halobetasol Propionate And Tazarotene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190425",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209354",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "HALOBETASOL PROPIONATE; TAZAROTENE",
"StrengthNumber": ".1; .45",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2023-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190425",
"SamplePackage": "Y",
"IndicationAndUsage": "DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults.",
"Description": "DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients in a white to off-white lotion formulation intended for topical use. Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is [(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate. The structural formula for halobetasol propionate is represented below. Molecular Formula: C25H31ClF2O5 Molecular Weight: 484.96. Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below. Molecular Formula: C21H21NO2S Molecular Weight: 351.46. Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%."
},
{
"NDCCode": "10631-122-04",
"PackageDescription": "59 g in 1 BOTTLE (10631-122-04) ",
"NDC11Code": "10631-0122-04",
"ProductNDC": "10631-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultravate",
"NonProprietaryName": "Halobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208183",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "HALOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.",
"Description": "ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone. It has the following structural formula. Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water."
},
{
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"PackageDescription": "2 BOTTLE in 1 CARTON (10631-122-51) > 59 g in 1 BOTTLE (10631-122-04) ",
"NDC11Code": "10631-0122-51",
"ProductNDC": "10631-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultravate",
"NonProprietaryName": "Halobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208183",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "HALOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180319",
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"IndicationAndUsage": "ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.",
"Description": "ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone. It has the following structural formula. Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water."
},
{
"NDCCode": "13668-484-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (13668-484-05) ",
"NDC11Code": "13668-0484-05",
"ProductNDC": "13668-484",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065062",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150402",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Upper respiratory tract infections caused by Streptococcus pneumoniae.Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.Infections in women caused by Neisseria gonorrhoeae.Syphilis caused by Treponema pallidum subspecies pallidum.Yaws caused by Treponema pallidum subspecies pertenue.Listeriosis due to Listeria monocytogenes.Anthrax due to Bacillus anthracis.Vincent’s infection caused by Fusobacterium fusiforme.Actinomycosis caused by Actinomyces israelii.Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. Each minocycline hydrochloride capsule, USP for oral administration contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac."
}
]
}
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<LastUpdate>2026-07-28</LastUpdate>
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<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
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<ApplicationNumber>ANDA076697</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
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<Description>Carbamazepine extended-release capsules are an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f] azepine-5-carboxamide, and its structural formula is. Carbamazepine extended-release capsules contain a single type of beads designed to provide twice daily dosing of carbamazepine. The inactive ingredients contained in carbamazepine extended-release capsules are:Ethylcellulose, medium chain triglycerides, oleic acid, hypromellose, polyethylene glycol, microcrystalline cellulose, colloidal silicon dioxide, and sodium lauryl sulfate. In addition: 1 The 100 mg capsule shell contains gelatin, titanium dioxide, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, and is imprinted with black ink., 2 The 200 mg capsule shell contains gelatin, titanium dioxide, D&C Yellow #10, and is imprinted with black ink., 3 The 300 mg capsule shell contains gelatin, titanium dioxide, D&C Red #28, FD&C Blue #1, black iron oxide, and is imprinted with black ink.</Description>
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<NonProprietaryName>Luffa Operculata Fruit</NonProprietaryName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>LUFFA OPERCULATA FRUIT</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>
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<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<ProductNDC>55700-484</ProductNDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<NDC11Code>55700-0004-12</NDC11Code>
<ProductNDC>55700-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20070228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077797</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>55700-044-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (55700-044-12)</PackageDescription>
<NDC11Code>55700-0044-12</NDC11Code>
<ProductNDC>55700-044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062935</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
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<PackageDescription>12 TABLET in 1 BOTTLE (55700-044-40)</PackageDescription>
<NDC11Code>55700-0044-40</NDC11Code>
<ProductNDC>55700-044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062935</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-064-12</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE (55700-064-12)</PackageDescription>
<NDC11Code>55700-0064-12</NDC11Code>
<ProductNDC>55700-064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-221-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (55700-221-12) </PackageDescription>
<NDC11Code>55700-0221-12</NDC11Code>
<ProductNDC>55700-221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-229-12</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-229-12)</PackageDescription>
<NDC11Code>55700-0229-12</NDC11Code>
<ProductNDC>55700-229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077797</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-261-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE, PLASTIC (55700-261-12) </PackageDescription>
<NDC11Code>55700-0261-12</NDC11Code>
<ProductNDC>55700-261</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>20060119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040655</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</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>Deprecated</Status>
<LastUpdate>2019-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-311-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (55700-311-12)</PackageDescription>
<NDC11Code>55700-0311-12</NDC11Code>
<ProductNDC>55700-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-412-12</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE (55700-412-12) </PackageDescription>
<NDC11Code>55700-0412-12</NDC11Code>
<ProductNDC>55700-412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091498</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated for the management of moderate to moderately severe pain in adults.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55700-627-12</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE (55700-627-12) </PackageDescription>
<NDC11Code>55700-0627-12</NDC11Code>
<ProductNDC>55700-627</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180518</StartMarketingDate>
<EndMarketingDate>20280131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078539</ApplicationNumber>
<LabelerName>Quality Care Products LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180518</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>55700-652-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (55700-652-12) </PackageDescription>
<NDC11Code>55700-0652-12</NDC11Code>
<ProductNDC>55700-652</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>20180713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209037</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>325; 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>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180713</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 UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [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 is 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, USP 5 mg/300 mg contains. Hydrocodone Bitartrate. . . . . . . . 5 mgAcetaminophen. . . . . . . . . . . . . .300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/300 mg contains. Hydrocodone Bitartrate. . . . . . . . .7.5 mgAcetaminophen. . . . . . . . . . . . . . 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/300 mg contains. Hydrocodone Bitartrate. . . . . . . . 10 mgAcetaminophen. . . . . . . . . . . . . .300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 5 mg/325 mg contains. Hydrocodone Bitartrate. . . . . . . . 5 mgAcetaminophen. . . . . . . . . . . . . .325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/325 mg contains. Hydrocodone Bitartrate. . . . . . . . .7.5 mgAcetaminophen. . . . . . . . . . . . . . 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/325 mg contains. Hydrocodone Bitartrate. . . . . . . . 10 mgAcetaminophen. . . . . . . . . . . . . .325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg: This product complies with USP dissolution test 2. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg: This product complies with USP dissolution test 1.</Description>
</NDC>
<NDC>
<NDCCode>55700-771-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (55700-771-12) </PackageDescription>
<NDC11Code>55700-0771-12</NDC11Code>
<ProductNDC>55700-771</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>20190628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211487</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>325; 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>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets, USP 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], reserve hydrocodone bitartrate and acetaminophen tablets, USP 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, USP is 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 Bitartate and Acetaminophen Tablet, USP contains. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide, crospovidone, pregelatinized starch, povidone, FD&C Yellow No 6 (for strength 5mg/325 mg), D&C Yellow No 10 (for strength 10 mg/325 mg) and stearic acid. Hydrocodone Bitartrate and Acetaminophen Tablets, USP complies to USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>55700-920-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (55700-920-12) </PackageDescription>
<NDC11Code>55700-0920-12</NDC11Code>
<ProductNDC>55700-920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209587</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; BUTALBITAL; CAFFEINE</SubstanceName>
<StrengthNumber>325; 50; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients. Inactive Ingredients: silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>55700-961-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (55700-961-12) </PackageDescription>
<NDC11Code>55700-0961-12</NDC11Code>
<ProductNDC>55700-961</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone</ProprietaryName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220131</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088481</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220131</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis and serum sickness.</IndicationAndUsage>
<Description>Dexamethasone Tablets 0.5 mg, 0.75 mg, 4 mg and 6 mg are for oral administration. Each tablet contains 0.5 mg, 0.75 mg, 4 mg or 6 mg of dexamethasone. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 0.5 mg tablet contains D&C Yellow #10. The 0.75 mg tablet contains D&C Yellow #10 and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>0121-0759-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (0121-0759-08) </PackageDescription>
<NDC11Code>00121-0759-08</NDC11Code>
<ProductNDC>0121-0759</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisolone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Prednisolone Sodium Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076913</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>PREDNISOLONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisolone sodium phosphate oral solution is indicated in the following conditions:.</IndicationAndUsage>
<Description>Prednisolone Sodium Phosphate Oral Solution is a dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base) in a palatable, aqueous vehicle. Inactive ingredients: Prednisolone Sodium Phosphate Oral Solution equivalent to 15 mg prednisolone per 5 mL contains the following inactive ingredients: anti-bitter mask, edetate disodium, glycerin, grape flavor, high fructose corn syrup, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic, potassium phosphate monobasic, purified water, and saccharin sodium. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)-,disodium salt, (11β)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. Its chemical structure is. Pharmacological Category: Glucocorticoid.</Description>
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<IndicationAndUsage>Prednisolone sodium phosphate oral solution is indicated in the following conditions. 1. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States. To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia. 4. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 5. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis. 6. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia. 7. Neoplastic Diseases. For the treatment of acute leukemia and aggressive lymphomas in adults and children. 8. Nervous System. Acute exacerbations of multiple sclerosis. 9. Ophthalmic Diseases. Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia. 10. Respiratory Diseases. Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “Allergic States”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia. 11. Rheumatic Disorders. As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); Trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).</IndicationAndUsage>
<Description>Prednisolone sodium phosphate oral solution is a dye free, clear, colorless to slightly yellow colored, raspberry flavored solution. Each 5 mL (teaspoonful) of prednisolone sodium phosphate oral solution contains 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) in a palatable, aqueous vehicle. Prednisolone sodium phosphate oral solution also contains edetate disodium, methylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sorbitol solution, and artificial raspberry flavor. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)-,disodium salt,(11β)-. The empirical formula is C 21H 27Na 2O 8P; the molecular weight is 484.39. Its chemical structure is. Pharmacological Category: Glucocorticoid.</Description>
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<IndicationAndUsage>Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions. 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides.3. Edematous States To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia.4. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.5. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis.6. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia.7. Neoplastic Diseases For the treatment of acute leukemia and aggressive lymphomas in adults and children.8. Nervous System Acute exacerbations of multiple sclerosis.9. Ophthalmic Diseases Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia.10. Respiratory Diseases Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “Allergic States”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti- PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia.11. Rheumatic DisordersAs adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis.12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); Trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).</IndicationAndUsage>
<Description>Prednisolone Sodium Phosphate Oral Solution is a dye free, colorless to light strawcolored, raspberry flavored solution. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) in a palatable, aqueous vehicle. Prednisolone Sodium Phosphate Oral Solution also contains dibasic sodium phosphate, edetate disodium, methylparaben, purified water, sodium biphosphate, sorbitol, natural and artificial raspberry flavor. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)-,disodium salt,(11β)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. The chemical structure is:. Pharmacological Category: Glucocorticoid.</Description>
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<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>PREDNISOLONE SODIUM PHOSPHATE</SubstanceName>
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<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisolone sodium phosphate oral solution is indicated in the following conditions:.</IndicationAndUsage>
<Description>Prednisolone Sodium Phosphate Oral Solution is a dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base) in a palatable, aqueous vehicle. Inactive ingredients: Prednisolone Sodium Phosphate Oral Solution equivalent to 15 mg prednisolone per 5 mL contains the following inactive ingredients: anti-bitter mask, edetate disodium, glycerin, grape flavor, high fructose corn syrup, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic, potassium phosphate monobasic, purified water, and saccharin sodium. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)-,disodium salt, (11β)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. Its chemical structure is. Pharmacological Category: Glucocorticoid.</Description>
</NDC>
<NDC>
<NDCCode>0187-0653-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>00187-0653-01</NDC11Code>
<ProductNDC>0187-0653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duobrii</ProprietaryName>
<NonProprietaryName>Halobetasol Propionate And Tazarotene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190425</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209354</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>HALOBETASOL PROPIONATE; TAZAROTENE</SubstanceName>
<StrengthNumber>.1; .45</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults.</IndicationAndUsage>
<Description>DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients in a white to off-white lotion formulation intended for topical use. Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is [(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate. The structural formula for halobetasol propionate is represented below. Molecular Formula: C25H31ClF2O5 Molecular Weight: 484.96. Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below. Molecular Formula: C21H21NO2S Molecular Weight: 351.46. Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%.</Description>
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<PackageDescription>6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE</PackageDescription>
<NDC11Code>00187-0653-03</NDC11Code>
<ProductNDC>0187-0653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duobrii</ProprietaryName>
<NonProprietaryName>Halobetasol Propionate And Tazarotene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190425</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209354</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>HALOBETASOL PROPIONATE; TAZAROTENE</SubstanceName>
<StrengthNumber>.1; .45</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-26</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190425</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults.</IndicationAndUsage>
<Description>DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients in a white to off-white lotion formulation intended for topical use. Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is [(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate. The structural formula for halobetasol propionate is represented below. Molecular Formula: C25H31ClF2O5 Molecular Weight: 484.96. Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below. Molecular Formula: C21H21NO2S Molecular Weight: 351.46. Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%.</Description>
</NDC>
<NDC>
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<PackageDescription>59 g in 1 BOTTLE (10631-122-04) </PackageDescription>
<NDC11Code>10631-0122-04</NDC11Code>
<ProductNDC>10631-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultravate</ProprietaryName>
<NonProprietaryName>Halobetasol Propionate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208183</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>HALOBETASOL PROPIONATE</SubstanceName>
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<StrengthUnit>mg/g</StrengthUnit>
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<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.</IndicationAndUsage>
<Description>ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone. It has the following structural formula. Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultravate</ProprietaryName>
<NonProprietaryName>Halobetasol Propionate</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208183</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.</IndicationAndUsage>
<Description>ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone. It has the following structural formula. Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20150402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065062</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
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<StartMarketingDatePackage>20150402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Upper respiratory tract infections caused by Streptococcus pneumoniae.Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.Infections in women caused by Neisseria gonorrhoeae.Syphilis caused by Treponema pallidum subspecies pallidum.Yaws caused by Treponema pallidum subspecies pertenue.Listeriosis due to Listeria monocytogenes.Anthrax due to Bacillus anthracis.Vincent’s infection caused by Fusobacterium fusiforme.Actinomycosis caused by Actinomyces israelii.Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. Each minocycline hydrochloride capsule, USP for oral administration contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
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