{
"NDC": [
{
"NDCCode": "48951-7018-1",
"PackageDescription": "10 BLISTER PACK in 1 BOX (48951-7018-1) > 2 g in 1 BLISTER PACK",
"NDC11Code": "48951-7018-01",
"ProductNDC": "48951-7018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Marjoram Melissa Adult Size",
"NonProprietaryName": "Marjoram Melissa Adult Size",
"DosageFormName": "SUPPOSITORY",
"RouteName": "VAGINAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "SWEET MARJORAM; MELISSA OFFICINALIS",
"StrengthNumber": "1; 1",
"StrengthUnit": "[hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2021-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "0115-7018-06",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (0115-7018-06)",
"NDC11Code": "00115-7018-06",
"ProductNDC": "0115-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065005",
"LabelerName": "Global Pharmaceuticals, Division of Impax Laboratories Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-04-13"
},
{
"NDCCode": "0115-7018-13",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0115-7018-13)",
"NDC11Code": "00115-7018-13",
"ProductNDC": "0115-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065005",
"LabelerName": "Global Pharmaceuticals, Division of Impax Laboratories Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-04-13"
},
{
"NDCCode": "0169-7208-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7208-01) * 8 mL in 1 SYRINGE, GLASS (0169-7018-98) * 8 mL in 1 VIAL, GLASS (0169-7218-11) ",
"NDC11Code": "00169-7208-01",
"ProductNDC": "0169-7208",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoseven",
"ProprietaryNameSuffix": "Rt",
"NonProprietaryName": "Coagulation Factor Viia (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20121029",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103665",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2022-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121029",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant), is indicated for: 1 Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets., 2 Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.",
"Description": "NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant) is a sterile, white lyophilized powder of recombinant human coagulation factor VIIa (rFVIIa) for reconstitution for intravenous injection. The product is supplied as single‑dose vials containing the following. NOVOSEVEN RT also contains trace amounts of proteins derived from the manufacturing and purification processes such as mouse IgG (maximum of 1.2 ng/mg), bovine IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of 19 ng/mg). The diluent for reconstitution of NOVOSEVEN RT is a 10 mmol solution of histidine in water for injection and is supplied as a clear colorless solution in a vial or pre-filled diluent syringe. After reconstitution with the appropriate volume of histidine diluent, each vial contains approximately 1 mg/mL NOVOSEVEN RT (corresponding to 1000 micrograms/mL). The reconstituted solution is a clear colorless solution with a pH of approximately 6.0 and contains no preservatives. Recombinant coagulation Factor VIIa (rFVIIa), the active ingredient in NOVOSEVEN RT, is a vitamin K‑dependent glycoprotein consisting of 406 amino acid residues with an approximate molecular mass of 50 kDa). It is structurally similar to endogenous human coagulation factor VIIa. The gene for human coagulation factor VII (FVII) is cloned and expressed in baby hamster kidney cells (BHK cells). Recombinant FVII is secreted into the culture media (containing newborn calf serum) in its single-chain form and then proteolytically converted by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic purification process. The purification process has been demonstrated to remove exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human serum or other proteins are used in the production or formulation of NOVOSEVEN RT."
},
{
"NDCCode": "0270-7018-27",
"PackageDescription": "10 BOTTLE, GLASS in 1 CASE (0270-7018-27) / 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00270-7018-27",
"ProductNDC": "0270-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iomervu",
"NonProprietaryName": "Iomeprol Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216016",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "IOMEPROL",
"StrengthNumber": "816",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "IOMERVU is a radiographic contrast agent indicated for:Intra-arterial Procedures† (1.1): 1 Cerebral arteriography, includingintra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients, 2 Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients, 3 Coronary arteriography and cardiac ventriculography in adults, 4 Radiographic evaluation of cardiac chambers and related arteries in pediatric patients .",
"Description": "IOMERVU (iomeprol) injection is a tri-iodinated, non-ionic radiographic contrast agent for intra-arterial or intravenous use. It is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow solution. The chemical name for iomeprol is N,N’-bis(2,3-dihydroxypropyl)-5-[(hydroxyacetyl)-methylamino]-2,4,6-tri-iodo-1,3-benzenedicarboxamide. Iomeprol has a molecular formula of C17H22I3N3O8, a molecular weight of 777.09 (iodine content of 49%), and the following structural formula:. IOMERVU injection is available in four iodine concentrations: : 1 IOMERVU 250 mg Iodine/mL: Each mL contains 510 mg iomeprol (providing 250 mg bound iodine) and 1 mg tromethamine. , 2 IOMERVU 300 mg Iodine/mL: Each mL contains 612 mg iomeprol (providing 300 mg bound iodine) and 1 mg tromethamine., 3 IOMERVU 350 mg Iodine/mL: Each mL contains 714 mg iomeprol (providing 350 mg bound iodine) and 1 mg tromethamine. , 4 IOMERVU 400 mg Iodine/mL: Each mL contains 816 mg iomeprol (providing 400 mg bound iodine) and 1 mg tromethamine."
},
{
"NDCCode": "0270-7018-29",
"PackageDescription": "10 BOTTLE, GLASS in 1 CASE (0270-7018-29) / 200 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00270-7018-29",
"ProductNDC": "0270-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iomervu",
"NonProprietaryName": "Iomeprol Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216016",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "IOMEPROL",
"StrengthNumber": "816",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "IOMERVU is a radiographic contrast agent indicated for:Intra-arterial Procedures† (1.1): 1 Cerebral arteriography, includingintra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients, 2 Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients, 3 Coronary arteriography and cardiac ventriculography in adults, 4 Radiographic evaluation of cardiac chambers and related arteries in pediatric patients .",
"Description": "IOMERVU (iomeprol) injection is a tri-iodinated, non-ionic radiographic contrast agent for intra-arterial or intravenous use. It is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow solution. The chemical name for iomeprol is N,N’-bis(2,3-dihydroxypropyl)-5-[(hydroxyacetyl)-methylamino]-2,4,6-tri-iodo-1,3-benzenedicarboxamide. Iomeprol has a molecular formula of C17H22I3N3O8, a molecular weight of 777.09 (iodine content of 49%), and the following structural formula:. IOMERVU injection is available in four iodine concentrations: : 1 IOMERVU 250 mg Iodine/mL: Each mL contains 510 mg iomeprol (providing 250 mg bound iodine) and 1 mg tromethamine. , 2 IOMERVU 300 mg Iodine/mL: Each mL contains 612 mg iomeprol (providing 300 mg bound iodine) and 1 mg tromethamine., 3 IOMERVU 350 mg Iodine/mL: Each mL contains 714 mg iomeprol (providing 350 mg bound iodine) and 1 mg tromethamine. , 4 IOMERVU 400 mg Iodine/mL: Each mL contains 816 mg iomeprol (providing 400 mg bound iodine) and 1 mg tromethamine."
},
{
"NDCCode": "0406-7018-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (0406-7018-03) ",
"NDC11Code": "00406-7018-03",
"ProductNDC": "0406-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Hcl",
"NonProprietaryName": "Buprenorphine Hcl",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20260119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218473",
"LabelerName": "SpecGx LLC",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260119",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.",
"Description": "Buprenorphine sublingual tablets are round, white to off-white tablets, debossed with an alphanumeric word identifying the product and strength. They contain buprenorphine HCl, a partial agonist at the mu-opioid receptor, and are available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP). Each tablet also contains mannitol, lactose, corn starch, povidone, citric acid, sodium citrate, and sodium stearyl fumarate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane."
},
{
"NDCCode": "0904-7018-46",
"PackageDescription": "30 TABLET in 1 BOTTLE (0904-7018-46) ",
"NDC11Code": "00904-7018-46",
"ProductNDC": "0904-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206505",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180115",
"SamplePackage": "N"
},
{
"NDCCode": "44385-7018-0",
"PackageDescription": "208197 mL in 1 DRUM (44385-7018-0)",
"NDC11Code": "44385-7018-00",
"ProductNDC": "44385-7018",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20201213",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Nice-Pak Products, Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "50090-7018-0",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7018-0) ",
"NDC11Code": "50090-7018-00",
"ProductNDC": "50090-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091352",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2."
},
{
"NDCCode": "50090-7018-2",
"PackageDescription": "15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7018-2) ",
"NDC11Code": "50090-7018-02",
"ProductNDC": "50090-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091352",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2."
},
{
"NDCCode": "50090-7018-3",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7018-3) ",
"NDC11Code": "50090-7018-03",
"ProductNDC": "50090-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091352",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2."
},
{
"NDCCode": "50090-7018-4",
"PackageDescription": "20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7018-4) ",
"NDC11Code": "50090-7018-04",
"ProductNDC": "50090-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091352",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2."
},
{
"NDCCode": "50090-7018-5",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7018-5) ",
"NDC11Code": "50090-7018-05",
"ProductNDC": "50090-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091352",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2."
},
{
"NDCCode": "50090-7018-6",
"PackageDescription": "200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7018-6) ",
"NDC11Code": "50090-7018-06",
"ProductNDC": "50090-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091352",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2."
},
{
"NDCCode": "50090-7018-7",
"PackageDescription": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7018-7) ",
"NDC11Code": "50090-7018-07",
"ProductNDC": "50090-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091352",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2."
},
{
"NDCCode": "50090-7018-8",
"PackageDescription": "7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7018-8) ",
"NDC11Code": "50090-7018-08",
"ProductNDC": "50090-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091352",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2."
},
{
"NDCCode": "52731-7018-2",
"PackageDescription": "1 BOTTLE in 1 BOX (52731-7018-2) > 50 mL in 1 BOTTLE (52731-7018-1)",
"NDC11Code": "52731-7018-02",
"ProductNDC": "52731-7018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Indigestion Complex",
"NonProprietaryName": "Alumina, Anacardium Orientale, Atropinum Sulphuricum, Berberis Vulgaris, Capsicum Annuum, Carbo Vegetabilis, Ignatia Amara, Lycopodium Clavatum, Nux Vomica, Robinia Pseud., Sulphuricum Acidum, Valeriana Officinalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nova Homeopathic Therapeutics, Inc.",
"SubstanceName": "ALUMINUM OXIDE; SEMECARPUS ANACARDIUM JUICE; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; CAPSICUM; ACTIVATED CHARCOAL; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID; VALERIAN",
"StrengthNumber": "8; 6; 6; 4; 4; 10; 6; 4; 4; 4; 6; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For oral use only."
},
{
"NDCCode": "62670-7018-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-7018-0) ",
"NDC11Code": "62670-7018-00",
"ProductNDC": "62670-7018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iced Lemon Pound Cake",
"ProprietaryNameSuffix": "Pistachio Milk And Honey",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260105",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "71",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260105",
"SamplePackage": "N",
"IndicationAndUsage": "Decreases bacteria on hands."
},
{
"NDCCode": "68788-7018-0",
"PackageDescription": "100 TABLET in 1 BOTTLE (68788-7018-0) ",
"NDC11Code": "68788-7018-00",
"ProductNDC": "68788-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metaxalone",
"NonProprietaryName": "Metaxalone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203695",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "METAXALONE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171011",
"SamplePackage": "N",
"IndicationAndUsage": "Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.",
"Description": "Metaxalone Tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending."
},
{
"NDCCode": "68788-7018-1",
"PackageDescription": "15 TABLET in 1 BOTTLE (68788-7018-1) ",
"NDC11Code": "68788-7018-01",
"ProductNDC": "68788-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metaxalone",
"NonProprietaryName": "Metaxalone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203695",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "METAXALONE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171011",
"SamplePackage": "N",
"IndicationAndUsage": "Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.",
"Description": "Metaxalone Tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending."
},
{
"NDCCode": "68788-7018-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (68788-7018-2) ",
"NDC11Code": "68788-7018-02",
"ProductNDC": "68788-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metaxalone",
"NonProprietaryName": "Metaxalone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203695",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "METAXALONE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171011",
"SamplePackage": "N",
"IndicationAndUsage": "Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.",
"Description": "Metaxalone Tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending."
},
{
"NDCCode": "68788-7018-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68788-7018-3) ",
"NDC11Code": "68788-7018-03",
"ProductNDC": "68788-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metaxalone",
"NonProprietaryName": "Metaxalone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203695",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "METAXALONE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171011",
"SamplePackage": "N",
"IndicationAndUsage": "Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.",
"Description": "Metaxalone Tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending."
},
{
"NDCCode": "68788-7018-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (68788-7018-6) ",
"NDC11Code": "68788-7018-06",
"ProductNDC": "68788-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metaxalone",
"NonProprietaryName": "Metaxalone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203695",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "METAXALONE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171011",
"SamplePackage": "N",
"IndicationAndUsage": "Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.",
"Description": "Metaxalone Tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending."
},
{
"NDCCode": "71872-7018-1",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (71872-7018-1) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71872-7018-01",
"ProductNDC": "71872-7018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20170228",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208871",
"LabelerName": "Medical Purchasing Solutions, LLC",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180228",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N"
},
{
"NDCCode": "76472-7018-2",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (76472-7018-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7018-1) ",
"NDC11Code": "76472-7018-02",
"ProductNDC": "76472-7018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Travel Reset",
"ProprietaryNameSuffix": "Jet Lag - Motion Sickness",
"NonProprietaryName": "Chamomilla 9c, Cocculus Indicus 9c, Ignatia Amara 9c, Ipecacuanha 9c, Lycopodium Clavatum 9c, Tabacum 9c",
"DosageFormName": "SPRAY",
"RouteName": "BUCCAL",
"StartMarketingDate": "20260814",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "SEVENE USA",
"SubstanceName": "ANAMIRTA COCCULUS FRUIT; MATRICARIA RECUTITA; CARAPICHEA IPECACUANHA WHOLE; STRYCHNOS IGNATII SEED; NICOTIANA TABACUM WHOLE; LYCOPODIUM CLAVATUM SPORE",
"StrengthNumber": ".1; .1; .1; .1; .1; .1",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260814",
"SamplePackage": "N",
"IndicationAndUsage": "CHAMOMILLA. Teething pain- Irritability - Restlessness .*. COCCULUS INDICUS. Motion Sickness (with a need to lie down) - Nausea - Sleepless Exhaustion .*. IGNATIA AMARA. Sleeplessness, Nervousness, Hypersensitivity from Stress or Due to Emotional shock .*. IPECACUANHA. Nausea - Vomiting - Morning sickness - Colic .*. LYCOPODIUM CLAVATUM. Bloating - Indigestion - Gas. TABACUM. Motion sickness Improved by Fresh Air - Nausea .*."
},
{
"NDCCode": "48951-0076-1",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-0076-1)",
"NDC11Code": "48951-0076-01",
"ProductNDC": "48951-0076",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apis Levisticum Ear Irritation Relief",
"NonProprietaryName": "Apis Mellifera, Levisticum Officinale Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc",
"SubstanceName": "APIS MELLIFERA; LEVISTICUM OFFICINALE LEAF",
"StrengthNumber": "3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "48951-0077-1",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-0077-1)",
"NDC11Code": "48951-0077-01",
"ProductNDC": "48951-0077",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Echinacea First Aid",
"NonProprietaryName": "Bellis Perennis, Echinacea Unspecified, Hamamelis Virginiana Root Bark/stem Bark, St. Johns Wort, Achillea Millefolium, Aconitum Napellus, Arnica Montana, Atropa Belladonna, Calendula Officinalis Flowering Top, Matricaria Recutita, Calcium Sulfide, Mercurius Solubilis, Comfrey Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc",
"SubstanceName": "BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ST. JOHN'S WORT; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; COMFREY ROOT",
"StrengthNumber": "5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 9; 9; 9",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "48951-0078-1",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-0078-1)",
"NDC11Code": "48951-0078-01",
"ProductNDC": "48951-0078",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Avena Valeriana Nerve Relief",
"NonProprietaryName": "Avena Sativa Flowering Top, Valerian, Ostrea Edulis Shell, Phosphorus, Sulfur",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; VALERIAN; OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR",
"StrengthNumber": "3; 3; 7; 30; 30",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "48951-1001-1",
"PackageDescription": "10 AMPULE in 1 PACKAGE (48951-1001-1) / 1 mL in 1 AMPULE",
"NDC11Code": "48951-1001-01",
"ProductNDC": "48951-1001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viscum Abietis",
"NonProprietaryName": "Viscum Album Fruiting Top",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc",
"SubstanceName": "VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "2",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE."
}
]
}
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<NDCList>
<NDC>
<NDCCode>48951-7018-1</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX (48951-7018-1) > 2 g in 1 BLISTER PACK</PackageDescription>
<NDC11Code>48951-7018-01</NDC11Code>
<ProductNDC>48951-7018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Marjoram Melissa Adult Size</ProprietaryName>
<NonProprietaryName>Marjoram Melissa Adult Size</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>SWEET MARJORAM; MELISSA OFFICINALIS</SubstanceName>
<StrengthNumber>1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0115-7018-06</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (0115-7018-06)</PackageDescription>
<NDC11Code>00115-7018-06</NDC11Code>
<ProductNDC>0115-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065005</ApplicationNumber>
<LabelerName>Global Pharmaceuticals, Division of Impax Laboratories Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>0115-7018-13</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0115-7018-13)</PackageDescription>
<NDC11Code>00115-7018-13</NDC11Code>
<ProductNDC>0115-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065005</ApplicationNumber>
<LabelerName>Global Pharmaceuticals, Division of Impax Laboratories Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>0169-7208-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7208-01) * 8 mL in 1 SYRINGE, GLASS (0169-7018-98) * 8 mL in 1 VIAL, GLASS (0169-7218-11) </PackageDescription>
<NDC11Code>00169-7208-01</NDC11Code>
<ProductNDC>0169-7208</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Novoseven</ProprietaryName>
<ProprietaryNameSuffix>Rt</ProprietaryNameSuffix>
<NonProprietaryName>Coagulation Factor Viia (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20121029</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103665</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant), is indicated for: 1 Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets., 2 Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.</IndicationAndUsage>
<Description>NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant) is a sterile, white lyophilized powder of recombinant human coagulation factor VIIa (rFVIIa) for reconstitution for intravenous injection. The product is supplied as single‑dose vials containing the following. NOVOSEVEN RT also contains trace amounts of proteins derived from the manufacturing and purification processes such as mouse IgG (maximum of 1.2 ng/mg), bovine IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of 19 ng/mg). The diluent for reconstitution of NOVOSEVEN RT is a 10 mmol solution of histidine in water for injection and is supplied as a clear colorless solution in a vial or pre-filled diluent syringe. After reconstitution with the appropriate volume of histidine diluent, each vial contains approximately 1 mg/mL NOVOSEVEN RT (corresponding to 1000 micrograms/mL). The reconstituted solution is a clear colorless solution with a pH of approximately 6.0 and contains no preservatives. Recombinant coagulation Factor VIIa (rFVIIa), the active ingredient in NOVOSEVEN RT, is a vitamin K‑dependent glycoprotein consisting of 406 amino acid residues with an approximate molecular mass of 50 kDa). It is structurally similar to endogenous human coagulation factor VIIa. The gene for human coagulation factor VII (FVII) is cloned and expressed in baby hamster kidney cells (BHK cells). Recombinant FVII is secreted into the culture media (containing newborn calf serum) in its single-chain form and then proteolytically converted by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic purification process. The purification process has been demonstrated to remove exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human serum or other proteins are used in the production or formulation of NOVOSEVEN RT.</Description>
</NDC>
<NDC>
<NDCCode>0270-7018-27</NDCCode>
<PackageDescription>10 BOTTLE, GLASS in 1 CASE (0270-7018-27) / 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00270-7018-27</NDC11Code>
<ProductNDC>0270-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iomervu</ProprietaryName>
<NonProprietaryName>Iomeprol Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216016</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>IOMEPROL</SubstanceName>
<StrengthNumber>816</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IOMERVU is a radiographic contrast agent indicated for:Intra-arterial Procedures† (1.1): 1 Cerebral arteriography, includingintra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients, 2 Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients, 3 Coronary arteriography and cardiac ventriculography in adults, 4 Radiographic evaluation of cardiac chambers and related arteries in pediatric patients .</IndicationAndUsage>
<Description>IOMERVU (iomeprol) injection is a tri-iodinated, non-ionic radiographic contrast agent for intra-arterial or intravenous use. It is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow solution. The chemical name for iomeprol is N,N’-bis(2,3-dihydroxypropyl)-5-[(hydroxyacetyl)-methylamino]-2,4,6-tri-iodo-1,3-benzenedicarboxamide. Iomeprol has a molecular formula of C17H22I3N3O8, a molecular weight of 777.09 (iodine content of 49%), and the following structural formula:. IOMERVU injection is available in four iodine concentrations: : 1 IOMERVU 250 mg Iodine/mL: Each mL contains 510 mg iomeprol (providing 250 mg bound iodine) and 1 mg tromethamine. , 2 IOMERVU 300 mg Iodine/mL: Each mL contains 612 mg iomeprol (providing 300 mg bound iodine) and 1 mg tromethamine., 3 IOMERVU 350 mg Iodine/mL: Each mL contains 714 mg iomeprol (providing 350 mg bound iodine) and 1 mg tromethamine. , 4 IOMERVU 400 mg Iodine/mL: Each mL contains 816 mg iomeprol (providing 400 mg bound iodine) and 1 mg tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>0270-7018-29</NDCCode>
<PackageDescription>10 BOTTLE, GLASS in 1 CASE (0270-7018-29) / 200 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00270-7018-29</NDC11Code>
<ProductNDC>0270-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iomervu</ProprietaryName>
<NonProprietaryName>Iomeprol Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216016</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>IOMEPROL</SubstanceName>
<StrengthNumber>816</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IOMERVU is a radiographic contrast agent indicated for:Intra-arterial Procedures† (1.1): 1 Cerebral arteriography, includingintra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients, 2 Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients, 3 Coronary arteriography and cardiac ventriculography in adults, 4 Radiographic evaluation of cardiac chambers and related arteries in pediatric patients .</IndicationAndUsage>
<Description>IOMERVU (iomeprol) injection is a tri-iodinated, non-ionic radiographic contrast agent for intra-arterial or intravenous use. It is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow solution. The chemical name for iomeprol is N,N’-bis(2,3-dihydroxypropyl)-5-[(hydroxyacetyl)-methylamino]-2,4,6-tri-iodo-1,3-benzenedicarboxamide. Iomeprol has a molecular formula of C17H22I3N3O8, a molecular weight of 777.09 (iodine content of 49%), and the following structural formula:. IOMERVU injection is available in four iodine concentrations: : 1 IOMERVU 250 mg Iodine/mL: Each mL contains 510 mg iomeprol (providing 250 mg bound iodine) and 1 mg tromethamine. , 2 IOMERVU 300 mg Iodine/mL: Each mL contains 612 mg iomeprol (providing 300 mg bound iodine) and 1 mg tromethamine., 3 IOMERVU 350 mg Iodine/mL: Each mL contains 714 mg iomeprol (providing 350 mg bound iodine) and 1 mg tromethamine. , 4 IOMERVU 400 mg Iodine/mL: Each mL contains 816 mg iomeprol (providing 400 mg bound iodine) and 1 mg tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>0406-7018-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0406-7018-03) </PackageDescription>
<NDC11Code>00406-7018-03</NDC11Code>
<ProductNDC>0406-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Hcl</ProprietaryName>
<NonProprietaryName>Buprenorphine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20260119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218473</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.</IndicationAndUsage>
<Description>Buprenorphine sublingual tablets are round, white to off-white tablets, debossed with an alphanumeric word identifying the product and strength. They contain buprenorphine HCl, a partial agonist at the mu-opioid receptor, and are available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP). Each tablet also contains mannitol, lactose, corn starch, povidone, citric acid, sodium citrate, and sodium stearyl fumarate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane.</Description>
</NDC>
<NDC>
<NDCCode>0904-7018-46</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0904-7018-46) </PackageDescription>
<NDC11Code>00904-7018-46</NDC11Code>
<ProductNDC>0904-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206505</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<IndicationAndUsage>Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4), 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5), 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6), 7 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule intended for oral administration contains 10 mg or 20 mg or 40 mg of omeprazole. In addition, each capsule contains the following inactive ingredients: acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac. Omeprazole Delayed-Release Capsules USP meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>52731-7018-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (52731-7018-2) > 50 mL in 1 BOTTLE (52731-7018-1)</PackageDescription>
<NDC11Code>52731-7018-02</NDC11Code>
<ProductNDC>52731-7018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Indigestion Complex</ProprietaryName>
<NonProprietaryName>Alumina, Anacardium Orientale, Atropinum Sulphuricum, Berberis Vulgaris, Capsicum Annuum, Carbo Vegetabilis, Ignatia Amara, Lycopodium Clavatum, Nux Vomica, Robinia Pseud., Sulphuricum Acidum, Valeriana Officinalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nova Homeopathic Therapeutics, Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; SEMECARPUS ANACARDIUM JUICE; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; CAPSICUM; ACTIVATED CHARCOAL; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID; VALERIAN</SubstanceName>
<StrengthNumber>8; 6; 6; 4; 4; 10; 6; 4; 4; 4; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For oral use only.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62670-7018-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-7018-0) </PackageDescription>
<NDC11Code>62670-7018-00</NDC11Code>
<ProductNDC>62670-7018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iced Lemon Pound Cake</ProprietaryName>
<ProprietaryNameSuffix>Pistachio Milk And Honey</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>71</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decreases bacteria on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68788-7018-0</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68788-7018-0) </PackageDescription>
<NDC11Code>68788-7018-00</NDC11Code>
<ProductNDC>68788-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metaxalone</ProprietaryName>
<NonProprietaryName>Metaxalone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203695</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METAXALONE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Metaxalone Tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>68788-7018-1</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (68788-7018-1) </PackageDescription>
<NDC11Code>68788-7018-01</NDC11Code>
<ProductNDC>68788-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metaxalone</ProprietaryName>
<NonProprietaryName>Metaxalone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203695</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METAXALONE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Metaxalone Tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>68788-7018-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (68788-7018-2) </PackageDescription>
<NDC11Code>68788-7018-02</NDC11Code>
<ProductNDC>68788-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metaxalone</ProprietaryName>
<NonProprietaryName>Metaxalone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203695</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METAXALONE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Metaxalone Tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>68788-7018-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68788-7018-3) </PackageDescription>
<NDC11Code>68788-7018-03</NDC11Code>
<ProductNDC>68788-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metaxalone</ProprietaryName>
<NonProprietaryName>Metaxalone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203695</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METAXALONE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Metaxalone Tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>68788-7018-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68788-7018-6) </PackageDescription>
<NDC11Code>68788-7018-06</NDC11Code>
<ProductNDC>68788-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metaxalone</ProprietaryName>
<NonProprietaryName>Metaxalone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203695</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METAXALONE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Metaxalone Tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The molecular formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone, USP is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>71872-7018-1</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (71872-7018-1) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71872-7018-01</NDC11Code>
<ProductNDC>71872-7018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170228</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208871</ApplicationNumber>
<LabelerName>Medical Purchasing Solutions, LLC</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76472-7018-2</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (76472-7018-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7018-1) </PackageDescription>
<NDC11Code>76472-7018-02</NDC11Code>
<ProductNDC>76472-7018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Travel Reset</ProprietaryName>
<ProprietaryNameSuffix>Jet Lag - Motion Sickness</ProprietaryNameSuffix>
<NonProprietaryName>Chamomilla 9c, Cocculus Indicus 9c, Ignatia Amara 9c, Ipecacuanha 9c, Lycopodium Clavatum 9c, Tabacum 9c</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20260814</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>SEVENE USA</LabelerName>
<SubstanceName>ANAMIRTA COCCULUS FRUIT; MATRICARIA RECUTITA; CARAPICHEA IPECACUANHA WHOLE; STRYCHNOS IGNATII SEED; NICOTIANA TABACUM WHOLE; LYCOPODIUM CLAVATUM SPORE</SubstanceName>
<StrengthNumber>.1; .1; .1; .1; .1; .1</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CHAMOMILLA. Teething pain- Irritability - Restlessness .*. COCCULUS INDICUS. Motion Sickness (with a need to lie down) - Nausea - Sleepless Exhaustion .*. IGNATIA AMARA. Sleeplessness, Nervousness, Hypersensitivity from Stress or Due to Emotional shock .*. IPECACUANHA. Nausea - Vomiting - Morning sickness - Colic .*. LYCOPODIUM CLAVATUM. Bloating - Indigestion - Gas. TABACUM. Motion sickness Improved by Fresh Air - Nausea .*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>48951-0076-1</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-0076-1)</PackageDescription>
<NDC11Code>48951-0076-01</NDC11Code>
<ProductNDC>48951-0076</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apis Levisticum Ear Irritation Relief</ProprietaryName>
<NonProprietaryName>Apis Mellifera, Levisticum Officinale Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc</LabelerName>
<SubstanceName>APIS MELLIFERA; LEVISTICUM OFFICINALE LEAF</SubstanceName>
<StrengthNumber>3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>48951-0077-1</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-0077-1)</PackageDescription>
<NDC11Code>48951-0077-01</NDC11Code>
<ProductNDC>48951-0077</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Echinacea First Aid</ProprietaryName>
<NonProprietaryName>Bellis Perennis, Echinacea Unspecified, Hamamelis Virginiana Root Bark/stem Bark, St. Johns Wort, Achillea Millefolium, Aconitum Napellus, Arnica Montana, Atropa Belladonna, Calendula Officinalis Flowering Top, Matricaria Recutita, Calcium Sulfide, Mercurius Solubilis, Comfrey Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc</LabelerName>
<SubstanceName>BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ST. JOHN'S WORT; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; COMFREY ROOT</SubstanceName>
<StrengthNumber>5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 9; 9; 9</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>48951-0078-1</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-0078-1)</PackageDescription>
<NDC11Code>48951-0078-01</NDC11Code>
<ProductNDC>48951-0078</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Avena Valeriana Nerve Relief</ProprietaryName>
<NonProprietaryName>Avena Sativa Flowering Top, Valerian, Ostrea Edulis Shell, Phosphorus, Sulfur</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; VALERIAN; OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR</SubstanceName>
<StrengthNumber>3; 3; 7; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>48951-1001-1</NDCCode>
<PackageDescription>10 AMPULE in 1 PACKAGE (48951-1001-1) / 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>48951-1001-01</NDC11Code>
<ProductNDC>48951-1001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viscum Abietis</ProprietaryName>
<NonProprietaryName>Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc</LabelerName>
<SubstanceName>VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE.</IndicationAndUsage>
</NDC>
</NDCList>